MEDICINAL PRODUCTS ACT (ZZdr-1)
 

I. GENERAL PROVISIONS
Article 1
(Scope of application and competences)
(1) This Act defines medicinal products for use in human and veterinary medicine, stipulates the conditions and measures for assuring their quality, safety and efficacy, the conditions and procedures for their testing, manufacture, price, sales, official control and supervision with the aim of protecting public health, as well as defines the establishment and tasks of the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia.
(2) This Act defines the conditions and procedures for industrially manufactured medicinal products or medicinal products produced in a way that includes industrial procedures, including pre-mixes for the preparation of medicated feedingstuffs, medicinal substances used as input materials for certain substances that can be used as veterinary medicinal products that have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties.
(3) The purpose of this Act is to transpose into the legislation of the Republic of Slovenia the contents of the following directives and regulations and to regulate certain issues concerning the implementation of the following regulations:
– Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use Official Journal L 121, 01/05/2001 p. 34, with all the applicable amendments, hereinafter: the Directive 2001/20/EC);
– Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (Official Journal L 311, 28/11/2001 p. 1, with all the applicable amendments, hereinafter: the Directive 2001/82/EC);
– Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Official Journal L 311, 28/11/2001 p. 67, with all the applicable amendments, hereinafter: the Directive 2001/83/EC);
– Directive 2003/94/EC of the European Parliament and of the Council of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Official Journal L 262, 14 October 2003 p. 22, with all the applicable amendments, hereinafter: the Directive 2003/94/EC);
– Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Official Journal L 91, 9 April 2005 p. 13, with all the applicable amendments, hereinafter: the Directive 2005/28/EC);
– Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (Official Journal L 224, 18 August 1990 p. 1, with all the applicable amendments, hereinafter: the Regulation 2377/90/EEC);
– Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State (Official Journal L 159, 27 June 2003 p. 1, with all the applicable amendments, hereinafter: the Regulation 1084/2003/EC);
– Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Official Journal L 136, 30 April 2004 p. 1, with all the applicable amendments, hereinafter: the Regulation 726/2004/EC);
Article 2
(Authority)
(1) The competent minister (hereinafter: the minister) for medicinal products shall be the minister competent for health, unless otherwise stipulated herein.
(2) The implementing regulations for the area of veterinary medicinal products shall be issued by the competent minister in agreement with the minister competent for veterinary medicine.
(3) The authority competent for medicinal products covered by this Act shall be the Agency for Medicinal Products and Medical Devices.
(4) The authority competent for medicinal products shall decide in administrative matters in accordance with the act governing the general administrative procedure, unless otherwise determined by this Act.
(5) Unless otherwise determined by this Act, the authority competent for medicinal products must request that any incomplete applications be supplemented within 30 days of receiving such application and set a deadline in which the applicant (hereinafter: the applicant) must supplement such application.

Article 3
(Committees and specialists)
(1) The authority competent for medicinal products has established permanent and temporary committees and uses the services provided by individual specialists (hereinafter: the specialist). Within the scope of their operation the committees and individual specialists shall have a consultative role and shall be professionally independent and autonomous.
(2) There are permanent committees operating in the area of medicinal products, clinical trials and pharmacopoeia.
(3) Permanent committees are specialist bodies in various fields of activities. For the area of medicinal products for human use the composition and the members of such committees shall be determined by the competent minister and for the area of medicinal products for use in veterinary medicine, it shall be determined by the minister responsible for veterinary medicine, from among the experts (hereinafter: the expert) in the field of pharmacy, medicine, veterinary medicine, pharmacology and other fields.
(4) The permanent committees shall adopt their rules of procedure.
(5) Temporary committees and individual specialists shall be appointed by the authority competent for medicinal products, to discuss and issue opinions in various areas of expertise requiring special skills.
(6) Members of the committees and individual specialists must not be biased and must act in accordance with the applicable regulations. Because of the conflict of interest, they may not enable unjustified benefits or prioritise individual applicants and must comply with the provisions on data confidentiality.
Article 4
(Specialists in the bodies of the European Union)
(1) The specialists co-operating with the competent bodies of the European Union responsible for medicinal products for use in human medicine shall be determined by the competent minister upon the proposal of the body competent for medicinal products.
(2) The specialists co-operating with the competent bodies of the European Union responsible for medicinal products for use in veterinary medicine shall be determined by the minister responsible for veterinary medicine upon the proposal of the body competent for medicinal products.
Article 5
(Definition of medicinal product)
(1) Medicinal product shall mean any substance or combination of substances presented for treating or preventing disease in human beings or animals.
(2) Any substance or combination of substances which may be used on or administered to human beings or animals with a view to restoring, improving or modifying their physiological functions by pharmacological, immunological or metabolic means, or making a medical diagnosis, shall likewise be considered a medicinal product.
(3) Substances referred to in the first paragraph of this Article may be:
1. Of human origin - e.g. human blood, blood preparations, blood products;
2. Of animal origin - e.g. animals, parts of organs, animal secretions, toxins, extracts, blood products;
3. Of plant origin - e.g. plants, parts of plants, plant secretions, plant extracts;
4. Of microbial origin – e.g. whole microorganisms, their constituents;
5. Of chemical origin - e.g. elements, chemical substances appearing in nature in a certain form; chemical products obtained by chemical change or synthesis;
6. Developed by means of by biotechnological processes.
Article 6
(Definitions of other terms)
For the purposes of this Act, the terms shall have the following meanings:
1. Quality analysis of the medicinal product shall mean a qualitative analysis of all constituents, quantitative analysis of at least all active substances and all other tests, requisite for assessing quality of medicinal products in compliance with the marketing authorisation requirements.
2. Biological medicinal product shall mean a medicinal product that contains biological substances or substances obtained through a process including biological systems. A biological substance is a substance obtained from, or through the use of, a biological source, the quality of which is determined by means of a combination of physico-chemical and biological testing, together with the manufacturing process and supervision. These are for example medicinal products made by means of a biological or biotechnical process, including cell cultures and recombinant DNA technology, medicinal products derived from blood and plasma, immunological medicinal products and similar.
3. Centralised procedure shall mean the procedure for obtaining a marketing authorisation for the medicinal product in the European Union, as defined by the Regulation 726/2004/EC.
4. Decentralised procedure shall mean the procedure for obtaining a marketing authorisation for the medicinal product initiated simultaneously in the reference Member State and the EU Member States concerned. It is mandatory for those medicinal products not subjected to centralised procedure which have not yet obtained the marketing authorisation for the medicinal product in the European Union and which will be marketed in more than one EU Member State, as stipulated by the Directives 2001/83/EC and 2001/82/EC.
5. Good distribution practice shall mean a qualitative system governing the organisation, implementation and control of product storage in accordance with a defined regime prior to their further use or putting into circulation and transportation of medicinal products from the manufacturer to the end-user.
6. Good clinical practice in clinical trials in human medicine shall mean an international ethical and scientific system of quality control, planning, implementation, recording, controlling and reporting on clinical trials on humans, providing for the credibility of data acquired through trials and the protection of rights and the safety of trial subjects (hereinafter: the trial subjects) pursuant to the Declaration of Helsinki of the World Medical Association on biomedical testing on human subjects (1964) with all the amendments as well as pursuant to this Act and any regulations arising hereof.
7. Good clinical practice in clinical trials in veterinary medicine shall mean an international ethical and scientific system of quality control, planning, implementation, recording, controlling and reporting on clinical trials on target animals providing for the credibility of data acquired through trials and the safety of trial subjects pursuant to this Act, any regulations arising hereof and regulations on animal protection.
8. Good control laboratory practice shall mean the system of the analytical testing of a medicinal product, which can also be part of good manufacturing practice used for controlling the quality of products.
9. Good laboratory practice shall mean a qualitative system governing organisational processes and conditions of planning, implementing, controlling, recording and reporting on non-clinical medical and environmental studies.
10. Good manufacturing practice shall mean a system for ensuring quality, providing for the consistent manufacture and control of products by qualitative criteria and conformity assessing criteria with intended purpose as required by the documentation needed for obtaining the marketing authorisation or the specification of the product.
11. European Pharmacopoeia shall mean the pharmacopoeia as defined by the Council of Europe Convention on the elaboration of a European Pharmacopoeia (1964).
12. Pharmaceutical form shall mean a form incorporating the active substance(s) producing effects of medicinal products through technological processes, taking into account the physical and chemical characteristics of agent(s) and substances with ancillary action.
13. Pharmacopoeia shall mean a list of provisions regulating the manufacture of medicinal products, their identification, establishing their purity and testing the other quality parameters of the medicinal product and its component substances.
14. Pharmacovigilance shall mean system of identifying, collecting and evaluating the adverse reactions to medicinal products and other findings about the safety of a medicinal product and measures taken with the aim of managing and reducing the risks arising from medicinal products.
15. Natural person shall mean an individual sole proprietor (hereinafter: the individual) or any other natural person with permanent residence in the European Union, performing a gainful activity as his/her exclusive business activity, who complies with the relevant criteria of the Member State concerned.
16. Galenic product for human use shall mean a medicinal product prepared in a galenic laboratory of a pharmacy pursuant to existing pharmacopoeia and the principles of good practices intended for retail supply by the pharmacy in question.
17. Galenic product for use in veterinary medicine shall mean a medicinal product prepared in a galenic laboratory of a pharmacy pursuant to existing pharmacopoeia and the principles of good practices intended for retail supply.
18. Generic medicinal product shall mean a medicinal product with the same qualitative and quantitative composition, active substances and pharmaceutical form as the reference medicinal product whose bioequivalence with the reference medicinal product has been proved by suitable bioavailability studies. Various salts, esters, ethers, isomers, mixed isomers, complexes or active substance derivatives shall be treated as equal active substance unless they differ considerably in terms of safety or efficacy or both. In such case, the applicant must submit additional information on the safety or efficacy or both of various salts, esters, active substance derivatives in a medicinal product for which a marketing authorisation has already been obtained. Different oral forms with immediate release are considered to be the same pharmaceutical forms. Bioavailability studies need not be submitted if so stipulated by the relevant instructions prepared in accordance with the scientific and technical knowledge.
19. Homeopathic medicinal product shall mean a medicinal product prepared from substances called homeopathic stock by a homeopathic method described in the European Pharmacopoeia or the existing Pharmacopoeias of the EU Member States, if the European Pharmacopoeia does not contain such provisions. A homeopathic medicinal product may also contain a number of essential components.
20. The name given to a medicinal product may be either an invented name which shall not be liable to confusion with the common name or scientific name, together with a trade mark or the name of the marketing authorisation holder.
21. Medicinal product marketing authorisation holder shall mean a natural person or a legal entity with the registered office in the European Union, meeting the conditions specified in the Act.
22. Immunological medicinal product shall be those which consist of vaccines, toxins, serums and allergens, namely:
a) Vaccines, toxins and serums shall cover in particular the agents used to diagnose the state of immunity:
- agents used to produce active immunity,
- agents used to produce passive immunity,
- agents used to diagnose the state of immunity;
b) Allergen product shall mean any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent;
c) Immunological medicinal product shall mean a medicinal product for use in veterinary medicine administered to animals in order to produce active or passive immunity or to diagnose the state of immunity.
23. The issue of a medicinal product shall mean retail sales to the end user, accompanied with adequate expert support and consultancy.
24. The manufacturer of a medicinal product shall mean a legal entity or a natural person holding a manufacturing authorisation pursuant to this Act and any regulations arising hereof.
25. Off-label use shall mean the use of a veterinary medicinal product which is not consistent with the summary of the product characteristics but nevertheless allowed under this Act and the act regulating veterinary conformity criteria.
26. Exit of a medicinal product shall mean the wholesale from the Republic of Slovenia into other EU Member States.
27. Exports of a medicinal product shall mean the wholesale from the Republic of Slovenia into third countries.
28. The strength of a medicinal product shall mean the content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form.
29. Withdrawal period shall mean the period necessary between the last administration of the veterinary medicinal product to animals under normal conditions of use pursuant to this Act and any regulations arising hereof and the beginning of the production of foodstuffs from such animals, in order to ensure that such foodstuffs do not contain residues in quantities in excess of the maximum limits laid down in Regulation No. 2377/90/EEC.
30. Magistral preparation for human use shall mean a medicinal product prepared in a pharmacy on prescription for an individual patient.
31. Magistral preparation for use in veterinary medicine shall mean a medicinal product prepared in a pharmacy on veterinary prescription for an animal or a small group of animals.
32. National procedure for obtaining a marketing authorisation for the medicinal product in the Republic of Slovenia shall mean the procedure for obtaining a marketing authorisation for those medicinal products which are not subject to centralised procedure and for which marketing authorisation will only be issued for the sales in the Republic of Slovenia.
33. Maximum residue limit shall mean the maximum residue limit of medicinal products for use in veterinary medicine as stipulated by the Regulation No. 2377/90/EEC.
34. Package insert shall mean the information for the user attached in written form to the medicinal product, as a rule in the form of a leaflet.
35. Unexpected adverse reaction of a medicinal product shall mean adverse reaction, the nature, severity or outcome of which is not consistent with the summary of the product characteristics.
36. Unexpected adverse reaction in clinical trials shall mean adverse reaction, the nature, severity or outcome of which is not consistent with the applicable product information (e.g. investigator's brochure or summary of product characteristics).
37. Adverse reaction in clinical trials shall mean any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
38. Adverse reaction to a medicinal product shall mean a reaction which is noxious and unintended and which occurs at doses normally used in humans or animals for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.
39. Human adverse reaction caused by veterinary medicinal products shall mean a reaction which is noxious and unintended and which occurs in humans unintentionally exposed to a veterinary medicinal product.
40. Adverse reaction in clinical trials shall mean all untoward and unintended responses to an investigational medicinal product related to any dose administered.
41. Public service obligation shall mean the obligation placed on wholesalers in medicinal products and holders of marketing authorisation to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.
42. Labelling of medicinal product shall mean information on the immediate or outer packaging.
43. Parallel distribution shall mean the entry of a medicinal product for which marketing authorisation was obtained in accordance with the centralised procedure from one Member State of the European Union or the European Economic Area (hereinafter: the EEA) to another, if performed by a wholesaler who is not in a business relationship for the marketing of such medicinal product with the holder of marketing authorisation, in accordance with the applicable regulations.
44. Parallel import shall mean the entry of a medicinal product for which marketing authorisation was obtained in the exporting country that is similar enough to the medicinal product for which marketing authorisation was obtained in the Republic of Slovenia according to the national procedure, the mutual recognition procedure or the decentralised procedure and is entered from one Member State of the European Union or the European Economic Area (hereinafter: the EEA) to another on the basis of the marketing authorisation for parallel imported medicinal product issued by a body competent for medicinal products if parallel import is performed by a wholesaler who is not in a business relationship for the marketing of such medicinal product with the holder of marketing authorisation.
45. Periodic safety update report shall be a periodic report submitted in predetermined intervals or upon the request of the body competent for medicinal products by the marketing authorisation holder, which must include all the prescribed data on the safety of the medicinal product and the estimate on the relationship between the risks and the benefits.
46. Substance with ancillary action shall mean substance having physical characteristics which can support the action of a medicinal product and improve its tolerability.
47. Mutual recognition procedure shall mean the procedure for obtaining marketing authorisation for the medicinal product initiated after the approval in the reference Member State also in other EU Member States concerned and is mandatory for those medicinal products not subjected to centralised or decentralised procedure for the issue of marketing authorisation which will be marketed in more than one EU Member State, as stipulated by the Directives 2001/83/EC and 2001/82/EC.
48. Pre-mixes for medicated feedingstuffs shall mean any medicinal product prepared in advance for use in veterinary medicine, intended for the subsequent manufacture of medicated feedingstuffs.
49. Representative of the marketing authorisation holder shall mean a legal entity or natural person acting on behalf of the marketing authorisation holder as its representative in the Republic of Slovenia.
50. Manufacturer of a medicinal product shall mean a legal entity or natural person responsible for the development, manufacture, quality control, packaging and labelling of medicinal products as well as their safety and efficacy irrespective of whether medicinal products were manufactured by themselves or on their behalf by a third party.
51. Wholesale distribution of medicinal products shall mean the activity of purchasing, storing, selling, entering, exiting, importing or exporting of medicinal products with the exception of issuing medicinal products to individual natural persons or legal entities for their personal use or the use in the performance of medical activity.
52. Radiopharmaceuticals are radiopharmaceuticals, radionuclide precursors, radionuclide generators and radionuclide kits, namely:
a) radiopharmaceutical shall mean a medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) intended for medicinal use,
b) radionuclide generator shall mean any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be obtained by elution or by any other method and used in a radiopharmaceutical,
c) radionuclide precursor shall mean any radionuclide produced for the labelling of another substance prior to administration to a patient,
č) radionuclide kit shall mean any preparation to be reconsitituted or combined with radionuclides (radionuclide precursors) in the final radiopharmaceutical, usually prior to its administration.
53. Risk/benefit balance shall mean a positive assessment of the therapeutic efficacy of a medicinal product in comparison with the risk, as defined in Points 64 and 65 hereunder.
54. Reference Member State shall mean the Member State which compiles, in the mutual recognition procedure or the decentralised procedure, the report on the assessment of the medicinal product on the basis of which the EU Member States concerned shall decide on the acceptability of the risk/benefit balance and/or the assessment of quality, safety and efficacy of a medicinal product in accordance with the Directives 2001/83/EC and 2001/82/EC.
55. Reference medicinal product shall mean a medicinal product for which marketing authorisation has been issued on the basis of Article 23 hereof and to whose documentation other applicants pursuant to this Act and any regulations arising hereof shall refer.
56. Serious adverse reaction or serious adverse reaction in clinical trials shall mean any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.
57. Serious adverse reaction of a medicinal product for use in human medicine shall mean any adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.
58. Serious adverse reaction of a medicinal product for use in veterinary medicine shall mean any adverse reaction which is fatal, life-threatening, incapacitating and constant, a prolonged occurrence of signs and symptoms of disease in a treated animal, or is a congenital anomaly/birth defect.
59. Risk medicinal products shall mean immunological medicinal products and medicinal products derived from blood and plasma.
60. Specialised shop selling over-the-counter medicinal products shall mean a retail outlet selling those medicinal products which the authority competent for medicinal products allows to be dispensed without prescription in pharmacies and specialised shops.
61. Common name of a medicinal product shall mean the international non-proprietary name recommended by the World Health Organization, or, if one does not exist, the usual common name.
62. Sponsor of a clinical trial shall mean a legal entity, natural person or individual who takes responsibility for the initiation, management and/or financing of a clinical trial.
63. Immediate packaging shall mean a container or other form of packaging immediately in contact with the medicinal product.
64. Study of the safety of medicinal product after obtaining the marketing authorisation for a medicinal product used in human medicine shall mean a pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying or quantifying a safety hazard relating to an authorised medicinal product.
65. Study of the safety of medicinal product after obtaining the marketing authorisation for a medicinal product used in veterinary medicine shall mean a pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying or investigating a safety hazard relating to an authorised medicinal product for use in veterinary medicine.
66. Traditional herbal medicinal product shall mean a herbal medicinal product whose properties can be recognised on the basis of its traditional use and which meets the conditions stipulated by this Act.
67. Third countries shall mean the Non-Member States of the European Union or the EEA Agreement.
68. Risk related to the use of medicinal product shall mean:
a) Any risk of the occurrence of environmentally harmful adverse reactions,
b) Any risk to the health of a patient or animal or public health, related to the quality, safety or efficacy of a medicinal product.
69. Active ingredient shall mean a substance which can support the action of a medicinal product.
70. Official control laboratory shall mean a legal entity or a natural person holding the authorisation of the authority competent for medicinal products for analytical testing of medicinal products appointed by the competent minister for verifying whether the official quality of medicinal products, which is a member of the European network of official control laboratories or which annually participates in the intra-laboratory verification organised by the European Directorate for the Quality of Medicines and the results achieved are in compliance with the organiser’s requirements;
71. Import of a medicinal product shall mean the wholesale from third countries into the Republic of Slovenia.
72. Wholesaler in medicinal products shall mean a legal entity or a natural person wholesaling medicinal products on the basis of the authorisation issued by the authority competent for medicinal products with the aim of generating profit or not.
73. Entry of a medicinal product shall mean the wholesale from other EU Member States into the Republic of Slovenia.
74. Member State concerned shall mean the Member State which shall decide, in the mutual recognition procedure or the decentralised procedure, on the acceptability of the risk/benefit balance and/or the assessment of quality, safety and efficacy of a medicinal product on the basis of the report on the assessment of the medicinal product compiled by a reference EU Member States in accordance with the Directives 2001/83/EC and 2001/82/EC.
75. Medicinal products derived from blood or plasma shall mean those medicinal products manufactured by means of industrial procedures by specialised legal entities or natural persons from blood components obtained in accordance with the provisions of the Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L no. 33 of 8.2.2002, p. 30) which contain above all albumin, coagulating factors and immunoglobulins of human origin, taking into account the self-sufficiency principle.
76. Medicated feedingstuffs shall mean any mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a medicinal product.
77. Herbal medicinal product shall mean any medicinal product which cannot contain one or more herbal substances, one or more herbal preparations or one or more herbal substances in combination with one or more herbal preparations as active ingredients.
78. Medical or veterinary prescription shall mean a document issued in accordance with the applicable regulations by an expert qualified and authorised to prescribe medicinal products.
79. Abuse of medicinal product shall mean persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effects.
80. Outer packaging shall mean the packaging into which is placed the immediate packaging.
Article 7
(Relationship between medicinal and other products)
(1) If, by definition and taking into account all its characteristics, a medicinal product can simultaneously be classified as medicinal product and as product subject to other provisions, the provisions of this Act shall apply in the case of doubt.
(2) The classification referred to in the previous paragraph shall be decided in an administrative procedure on the basis of a special declaratory procedure by the authority competent for medicinal products.
(3) The costs of establishing the adequacy of the proposed definition shall be borne by the applicant.
Article 8
(Prohibition of inappropriate presentation of products)
It is prohibited to place on the market any products with an alleged healing properties or disease prevention properties for use in human or veterinary medicine which pursuant to this Act, are not considered a medicinal product.
Article 9
(Equal manufacturing requirements)
The provisions of this Act on manufacturing and import shall also apply to medicinal products intended for placement on the market outside the territory of the Republic of Slovenia and for intermediate products not intended for further processing.
Article 10
(Exceptions to the application of this Act)
The provisions of this Act shall not apply to the following:
1. Magistral preparations regulated by the provisions on pharmaceutical activity;
2. Galenic products regulated by the provisions on pharmaceutical activity;
3. Intermediate products intended for further processing by manufacturing authorisation holders, if intermediate products are not regulated as medicinal products;
4. Radioactive isotopes in the form of sealed sources regulated by the provisions on protection against ionising radiation and nuclear safety;
5. Blood, plasma or blood cells regulated by the provisions on blood supply, except for industrially processed plasma;
6. Medicated feedingstuffs regulated by the provisions on feedingstuffs;
7. Inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality regulated by the provisions on veterinary medicine;
8. Feed additives stipulated by the provisions on feedingstuffs.
Article 11
(Classification of medicinal products on the basis of prescribing practices)
(1) In terms of prescribing practices, medicinal products shall be classified into:
- medicinal products for which medical or veterinary prescription is required,
- medicinal products for which medical or veterinary prescription is not required,
(2) The competent minister shall determine the definition, classification and the manner of prescribing medicinal products.
Article 12
(Protection of data upon the modification of classification)
If a modification of classification is approved for a medicinal product for which medical or veterinary prescription is required among medicinal products for which no medical or veterinary prescription is required on the basis of significant non-clinical pharmacotoxicological tests or clinical trials, the authority competent for medicinal products shall not be allowed to refer to the results of such tests or clinical trials when studying the application of another applicant or marketing authorisation holder for a modification in the classification of the same active ingredient in the period of one year after the first approval of modification.
Article 13
(Traditional herbal medicinal products)
(1) Traditional herbal medicinal products must meet the following requirements:
1. They may have therapeutic indications, suitable for traditional herbal medicinal products only, which, by virtue of their composition and purpose, are intended for self-medication;
2. They can only be administered in accordance with the prescribed strength and dosage;
3. They are intended for oral or external use or for inhalation;
4. The period of its traditional use has expired;
5. The data on the traditional use of medicinal product must be sufficient; in particular, it must be proved that the product is not harmful if used as foreseen and that the pharmacological effects or efficacy of the medicinal product are probable on the basis of long-term use and experience.
(2) Traditional herbal medicinal products ma also contain vitamins and minerals provided that there exists documented evidence on their safety and that such vitamins and minerals support the activity of herbal substances in terms of the stated therapeutic indications.
(3) If the authority competent for medicinal products establishes that the traditional herbal medicinal product meets the criteria for obtaining the marketing authorisation or registration for the homeopathic medicinal product, the provisions applicable to traditional herbal medicinal product shall not apply.
Article 14
(Homeopathic medicinal products)
(1) Marketing authorisation for homeopathic medicinal products must be obtained pursuant to Article 23 hereof.
(2) Notwithstanding the provision of the previous paragraph, a simplified procedure for obtaining the marketing authorisation (registration procedure) shall be applied to homeopathic medicinal products for external or oral use, provided that they meet the following requirements:
1. The outer packaging and the instructions for use do not indicate any healing effect or therapeutic indication or information relating to them;
2. They have a sufficient degree of dilution to guarantee the safety of the product, as stipulated by the regulations.
(3) All the provisions of this Act shall apply to all homeopathic medicinal products, unless otherwise stipulated herein.
(4) A more specific determination, labelling, advertising and conditions for the issue of marketing authorisation and the simplified registration procedure for homeopathic medicinal products shall be determined by the competent minister.
Article 15
(List of urgently needed medicinal products)
(1) The competent minister may prescribe a list of urgently needed medicinal products for use in human medicine.
(2) The minister competent for veterinary medicine may prescribe a list of urgently needed medicinal products for use in veterinary medicine.
(3) Urgently needed medicinal products are those which are necessary in the provision of human and/or animal health care on the basis of the latest findings of biomedical science and profession and the systemic definitions in the framework of the national health priorities.
Article 16
(Interchangeable medicinal products)
(1) Interchangeable medicinal products are those products that the body competent for medicinal products defines and publishes as suitable for interchanging, taking into account the fact that the probability of the occurrence of clinically significant differences in the efficiency and safety of such medicinal products are adequately low or negligible; such decision must be supported by:
- Identification of common or comparable characteristics of medicinal products or groups of medicinal products pursuant to this Act or the regulations adopted on its basis;
- Consideration of provisions stipulated by marketing authorisation;
- Incorporation of the latest findings and discoveries of biomedical science and profession;
- Opinion of the Medicinal Products Committee;
- Data on pharmacovigilance.
(2) Medicinal products referred to in the previous paragraph can only be interchanged by persons authorised for prescribing medicinal products or persons authorised for issuing medicinal products, as stipulated by the relevant provisions.
(3) The competent minister shall prescribe more detailed requirements and procedures for establishing interchangeability of medicinal products.
Article 17
(Marketed medicinal product)
(1) A medicinal product can be marketed:
- Provided that it has obtained marketing authorisation in accordance with this Act or the centralised procedures stipulated by the provisions of the European Union;
- Provided that it is authorised for the needs of an individual patient by the authority competent for medicinal products upon the request of the personal physician, clinic or institute, at their personal responsibility;
- Provided that the authority competent for medicinal products temporarily allows the marketing of a medicinal product without marketing authorisation in exceptional situations (infections, poisoning, radiation and similar) or for any other reasons in the interest of public health protection;
- Provided that the authority competent for medicinal products, on the proposal of the authority competent for veterinary medicine temporarily allows the marketing of an immunological veterinary medicinal product without marketing authorisation, if no appropriate medicinal product is available, in which case the body competent for veterinary medicine informs the European Commission in advance of the conditions of use; or
- Provided that it is included in the list of urgently needed medicinal products, stipulated in Article 15 hereof, without marketing authorisation.
(2) Notwithstanding the provision of the first indent of the previous paragraph, medicinal products without marketing authorisation can be used for research and development purposes as well as those with appropriate authorisation for clinical trials or further processing.
(3) Notwithstanding the provision of the first indent of the previous paragraph hereunder, veterinary medicinal products without marketing authorisation can be used for veterinary emergencies (for example prevention of foot-and-mouth disease) if their use in such conditions is approved by the authority competent for veterinary medicine and the competent institution of the European Union.
Article 18
(Off-label use of veterinary medicinal products)
(1) If no suitable veterinary medicinal product with adequate marketing authorisation for the Republic of Slovenia is available to treat the disease state of certain animal species, a veterinary responsible for the treatment of animals can, in order to prevent unacceptable suffering of animals, exceptionally approve medicinal products without marketing authorisation for the use in such species or to treat the disease state concerned.
(2) The competent minister shall determine in greater detail the conditions for off-label use.
Article 19
(Responsibility)
(1) The marketing authorisation holder shall be responsible for the placing of medicinal product on the market.
(2) The manufacturer of the medicinal product shall be responsible for the damage caused by inappropriate quality of the medicinal product or the consequences of the use of such medicinal product even if it is proved that it would not be possible for the global science to discover the defect or the consequences of use, in view of the current level of technological development in the moment the medical product was placed on the market.
(3) Marketing authorisation holder, manufacturer and health professionals shall not be responsible for the consequences of treatment arising from the use of medicinal product which is not in accordance with the issued marketing authorisation or the use of medicinal product without a marketing authorisation, if such use was recommended or requested by the authority competent for medicinal products in the event of the spread of pathogenic substances, toxins, chemical substances or nuclear radiation which could be harmful to the health of humans or animals or damage the environment.
Article 20
(Pharmacopoeia)
(1) Medicinal products marketed in the Republic of Slovenia must be manufactured and controlled according to the requirements of the European Pharmacopoeia and the Slovene national supplement thereof as prescribed by the competent minister.
Should the European Pharmacopoeia and the Slovene national supplement thereof not prescribe methods of manufacture and requirements concerning quality of medicinal products, such medicinal products may be manufactured and controlled according to methods and requirements of pharmacopoeias of other EU Member States. Should the pharmacopoeias of other EU Member States not prescribe methods of manufacture and requirements concerning quality, medicinal products may subjected to methods and requirements of the pharmacopoeias of third countries or to the methods proposed by the manufacturer.
II. MARKETING AUTHORISATION
Article 21
(Marketing authorisation)
(1) A medicinal product can only be marketed on the basis of marketing authorisation.
(2) Notwithstanding the provisions of the previous paragraph, the marketing authorisation shall not be required for medicinal products stated in Article 10 of this Act and for the following:
1. Medicinal products subject to clinical trials;
2. Medicinal products intended for treatment as a continuation of a treatment started abroad;
3. Intermediate products which will be processed further;
4. Medicinal products to be used in research and development;
5. Medicinal products with marketing authorisation for parallel imported medicinal products.
Article 22
(Marketing authorisation holder)
(1) The procedure for the issue of marketing authorisation shall begin with the submission of an application by a natural person or legal entity with registered office in the European Union. This can be either the manufacturer of the medicinal product or a natural person or a legal entity that has concluded a written agreement with the manufacturer and meets the requirements stipulated hereby.
(2) The marketing authorisation holder shall have established a pharmacovigilance system and appointed an appropriately qualified person responsible for pharmacovigilance, who must be available at all times.
(3) Such appropriately qualified person responsible for pharmacovigilance must have a permanent residence on the territory of the European Union and hold a university degree in pharmacy or human medicine specialised in human medicinal products or hold a university degree in pharmacy or veterinary medicine specialised in veterinary medicinal products. If such person does not have appropriate qualification, then he or she must have the possibility to seek professional assistance of a person holding a university degree in pharmacy or human medicine specialised in human medicinal products or holding a university degree in pharmacy or veterinary medicine specialised in veterinary medicinal products at all times.
(4) If the marketing authorisation holder does not have a registered office in the Republic of Slovenia, it can appoint, besides the responsible person, also a contact person for pharmacovigilance on the territory of the Republic of Slovenia.
Article 23
(Application for obtaining marketing authorisation)
(1) The application for obtaining marketing authorisation shall comprise documents, samples and reference standards, if necessary and if required by the authority competent for medicinal products.
(2) The documents pursuant to the preceding paragraph shall comprise:
1. General part, including data on the manufacturer, manufacturing site and the applicant for marketing authorisation, data on medicinal product, data on previously issued or rejected marketing authorisations, the summary of product characteristics, package insert, draft packaging, data on the status of orphan medicinal products, if obtained, expert reports and summaries, estimates of risk/benefit balance, environmental impact assessment and other data necessary for public health protection, especially in the case of risk medicinal products.
2. Pharmaceutical-chemical and biological part including data on quality and quantity of the composition, description of the method of preparation, quality control of starting material, quality control carried out at intermediate stages of the manufacturing process, quality control of the finished product, stability tests and other data necessary for public health protection.
3. Non-clinical pharmacotoxicological part, including data on the pharmacodynamic and pharmacokinetic properties of a medicinal product, its toxicity and effect on the reproductive function, data on embryo-foetal toxicity, mutagenic potential and carcinogenic potential, data on local tolerance, excretion and other data necessary for public health protection. The pharmacotoxicological part of the documentation related to veterinary medicinal product should also include data on residues and proposed withdrawal periods.
4. Clinical part of documentation including general data on trials, how they have been carried out and ensuing results, clinical and pharmacological data, data on bioavailability/bioequivalence (if required), clinical safety and efficacy, documentation on exceptional circumstances in trials (if required) and data on experience with the product gained in other countries which have authorised marketing and other data necessary for public health protection.
Article 24
(Expert advice)
Before the beginning of the procedure for obtaining marketing authorisation, the authority competent for medicinal products shall provide orientations and advice, if requested by the client, concerning the compilation and the expert contents of the application.

Article 25
(Generic medicinal products)
(1) Notwithstanding the provisions of Article 23 of this Act, the applicant need not submit the results of non-clinical pharmacotoxicological tests or clinical trials of the veterinary medicinal products nor the results of residue tests, if proven that the subject of the procedure is a generic medicinal product whose reference medicinal product has obtained marketing authorisation in the Republic of Slovenia or the European Union at least eight years earlier.
(2) A generic medicinal product referred to in the previous paragraph may not be marketed for ten years after obtaining the marketing authorisation for the reference medicinal product.
(3) If the reference medicinal product referred to in the first paragraph hereunder did not obtain marketing authorisation in the Republic of Slovenia, the applicant shall state in the application for obtaining marketing authorisation the EU Member State in which such authorisation had been obtained.
(4) Within 30 days of receiving the complete application the authority competent for medicinal products shall ask the competent authority of the selected Member State of the European Union to issue the certificate of issued marketing authorisation for the reference medicinal product concerned and the qualitative and quantitative particulars of the composition in terms of the active substances and constituents of the excipient of the reference medicinal product and, if necessary, any other relevant documents.
(5) In line with the EU regulations, a Member State that issued the marketing authorisation for the reference medicinal product shall send the certificate and data referred to in the previous paragraph within one month of receiving the request.
Article 26
(Data protection)
(1) The ten-year period referred to in the second paragraph of the previous Article shall be extended to a maximum of 11 years if, during the first eight years of the ten-year period referred to in the second paragraph of the previous Article, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which are expected to bring a significant clinical benefit in comparison with existing therapies.
(2) For veterinary medicinal products the ten-year period referred to in the second paragraph of the previous Article shall be extended to 13 years in respect of medicinal products for fish, bees and other animal species pursuant to this Act and any regulations arising hereof.
Article 27
(Additional requirements)
If a medicinal product does not correspond to the definition of a generic medicinal product or if bioequivalence cannot be proven by means of suitable bioavailability studies or changes in the active substances, indications, strength, pharmaceutical form or method administration in respect to the reference medicinal product, it shall be necessary to submit the results of non-clinical pharmacotoxicological tests or clinical trials of the veterinary medicinal products as well as the results of the tests of safety and residues of the medicinal product.

Article 28
(Biological medicinal products)
If a biological medicinal product similar to the reference medicinal product does not correspond to the definition of a generic medicinal product because of the differences related to starting materials or manufacturing procedure compared to the reference medicinal product, the application for marketing authorisation shall be accompanied by the results of adequate non-clinical pharmacotoxicological tests or clinical trials relating to the stated differences. The type and scope of additionally required data shall be in compliance with the requirements of this Act and any regulations arising hereof.
Article 29
(Well established use)
Notwithstanding the provisions of Article 23 of this Act, the applicant need not submit own data on non-clinical pharmacotoxicological tests or clinical trials of the veterinary medicinal products nor the results of residue tests, if proven that the active substance of the veterinary medicinal product have a well-established medicinal or veterinary use, with recognized efficacy and an acceptable level of safety, and has been used on the territory of the European Union in appropriate scope for at least ten years and if enough literature on the use of active substance is available. In such case, adequate data from the available literature must be submitted instead of own data.
Article 30
(Well established use and data protection)
(1) If the components of the medicinal product have a well-established medicinal use, with recognized efficacy and an acceptable level of safety and such medicinal product has obtained marketing authorisation for a new indication for which significant non-clinical pharmacotoxicological tests or clinical trials have been submitted, other applicants shall not be allowed to refer to this part of documentation for a non-cumulative period of up to one year.
(2) If the applicant has used scientific literature for obtaining marketing authorisation for a veterinary medicinal product for use in food producing animals and has submitted, in respect of the same medicinal product and for the needs of obtaining authorisation for another species of food producing animals, new studies on medicinal product residues in accordance with the Regulation 2377/90/EEC together with further clinical trials, then other applicants may not refer to the data of such studies or the results of tests in accordance with the provisions of Article 25 hereof for the period of three years following the issue of marketing authorisation for the purpose of which they have been carried out.
Article 31
(Data protection for veterinary medicinal products)
(1) In veterinary medicinal products foreseen for one or more species of food producing animals which contain new active substances and have not been allowed in the European Union before 30 April 2004, the ten-year period stipulated by the second paragraph of Article 25 hereof shall be extended by one year in each case of extension to the marketing authorisation for another species of food producing animals, provided that such extension to the marketing authorisation is obtained within five days of issuing the initial marketing authorisation.
(2) The period stipulated by the second paragraph of Article 25 hereof, together with any extensions under the previous paragraph may not be longer than 13 years which also applies to the extension to marketing authorisation related to four or more species of food producing animals.
(3) The extension of the ten-year period to 11, 12 or 13 years for a veterinary medicinal product, foreseen for food producing animals, shall only be granted if the marketing authorisation holder has previously submitted the application for determination of maximum residue limit for those species covered by the marketing authorisation.
Article 32
(Generic medicinal products and patent rights)
The necessary studies conducted with the aim of fulfilling the requirements of Articles 25, 27, 28 and 29 hereof and meeting other requirements related to the obtaining of marketing authorisation shall not represent a violation of patent rights or the rights arising from additional safety certificate for a medicinal product.
Article 33
(Combinations of active substances)
If the application concerns new medicinal products containing active substances present in the medicinal products for which marketing authorisations have already been issued, however, not hitherto used in the proposed combination for therapeutic purposes, the results of toxicological and pharmacological tests and of clinical trials relating to that combination must be provided, but it shall not be necessary to provide references relating to each individual substance. The application for veterinary medicinal products must also contain the results of safety and residue tests, if necessary or required by the authority competent for medicinal products.
Article 34
(Approved use of documentation)
Marketing authorisation holder may authorise the use of data from the pharmaceutical, chemical, biological, non-clinical pharmacological-toxicological and clinical part of documentation for veterinary medicinal products as well as data from the documentation on safety and residue tests which is a constituent part of the application on the basis of which the marketing authorisation has been obtained, for compiling or processing the subsequent applications for other medicinal products with the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.
Article 35
(Exceptional circumstances)
Notwithstanding the provisions of Article 23 of this Act and in exceptional circumstances related to immunological medicinal products for the use in veterinary medicine, the applicant need not submit the results of certain on-the-field tests carried out in the target species if such tests cannot be carried out because of well-grounded reasons.
Article 36
(Registration of a traditional medicinal product)
(1) Simplified procedure for obtaining the marketing authorisation shall be applied to traditional herbal medicinal products (traditional medicinal product registration procedure), in which the applicant shall enclose with the application a general part and the pharmaceutical-chemical and biological documentation in accordance with Points 1 and 2 of the second paragraph of Article 23 hereof. Instead of data referred to in Points 3 and 4 of the second paragraph of Article 23 of this Act, the following shall be submitted:
1. Bibliographic or expert evidence that the medicinal product concerned, or other appropriate medicinal product had been used for medical purposes for at least 30 years prior to the date of application, of which at least 15 years in the European Union. If a medicinal product had been used in the European Union for less than 15 years and nevertheless meets the conditions prescribed for traditional herbal medicinal products, the authority competent for medicinal products shall submit evidence of long-term use of such medicinal product or another adequate medicinal product to the European Medicines Agency; and
2. Bibliographic overview of data on the safety, together with the expert report and, if requested by the authority competent for medicinal products, any other data needed for the assessment of safety of the medicinal product.
(2) The competent minister shall prescribe the necessary evidence of medical use during the 30-year period, the requirements for other appropriate medicinal product and the form and contents of the required documentation in the national procedure, mutual recognition procedure and decentralised procedure, as well as the method of resolving any arbitration proceedings, the rules of labelling and advertising for traditional herbal medicinal products.
Article 37
(Emergency procedures)
(1) Notwithstanding the provisions of Articles 23 and 25 to 36 hereof, the competent authority may, in order to protect public health in the event of a threat to human life or health, issue ex officio marketing authorisation on the basis of the facts established in the report on the assessment of medicinal product and in the valid marketing authorisation for the medicinal product concerned, obtained from the authority competent for medicinal products in the selected Member State. The marketing authorisation holder in the Member State in which the medicinal product concerned is authorised shall be informed of the application for the issue of marketing authorisation pursuant to this Article.
(2) A wholesaler marketing the medicinal product referred to in the previous paragraph shall be responsible for labelling, package insert, summary of the product characteristics, advertising and pharmacovigilance.
Article 38
(Procedure for obtaining marketing authorization)
(1) The authority competent for medicinal products shall verify the completeness of the application for marketing authorisation within 60 days of receiving it.
(2) The applicant shall enclose with the application, if requested by the authority competent for medicinal products the samples of medicinal product, its starting materials and, if need be, its intermediate products or other constituent materials, which will be submitted to the official control laboratory for establishing the adequacy and reproducibility of control methods used by the manufacturer.
(3) During the evidence-taking procedure prior to the issue of marketing authorisation, the authority competent for medicinal products may order analytical testing of medicinal products in the official control laboratory, assessment of adherence to good practices by persons stated in the documentation, verification of analytical methods aimed at discovering and defining residues of veterinary medicinal products, request additional data and explanations or other relevant evidence.
(4) During the evidence-taking procedure prior to the issue of marketing authorisation, the authority competent for medicinal products must verify compliance with the principles and guidelines of good practices by persons from third countries stated in the documentation.
(5) The Committee on Medicinal Products shall issue an opinion on the quality, safety and efficacy of a medicinal product and the risk/benefit balance which will serve as the basis for drafting the report on the assessment of the medicinal product.
(6) The authority competent for medicinal products shall adopt a decision on the application for marketing authorisation within 210 days of receiving a complete application.
(7) The procedure shall be suspended until the fulfilment of requirements laid down in paragraphs 2 and 3 of this Article within the prescribed deadlines.
(8) Marketing authorisation shall, as a rule, be issued for a period of five years, unless otherwise determined by this Act.
Article 39
(Mutual recognition)
(1) Notwithstanding the provisions of the previous Article, the authority competent for medicinal products shall issue or reject the issue of marketing authorisation in the application for obtaining marketing authorisation according to the mutual recognition procedure or the decentralised procedure on the basis of the assessment report compiled by the reference Member State.
(2) The competent minister shall prescribe the contents of the application, the conditions for obtaining marketing authorisation, the form and contents of the required documentation in the national procedure, mutual recognition procedure or decentralised procedure, as well as more detailed conditions for obtaining marketing authorisation pursuant to Articles 37 and 38 and the first paragraph hereunder.
Article 40
(Conditional marketing authorisation)
In exceptional circumstances and following consultation with the applicant, the authority competent for medicinal products may grant authorisation subject to a requirement for the applicant to introduce specific procedures, in particular concerning product safety, notification to the relevant authorities of any incident relating to its use, and action to be taken. Such authorisation may only be issued for objective and verifiable reasons prescribed by the competent minister. Continuation of the validity of authorisation shall be linked to the annual reassessment of the fulfilment of these conditions. On the basis of positive assessment of the fulfilment of these conditions, the authority competent for medicinal products shall issue a new decision, which shall also be published. The list of requirements shall be made public together with the final deadlines for meeting them.
Article 41
(Scope of marketing authorization)
Notwithstanding the fact whether a separate marketing authorisation is issued for additional strengths, pharmaceutical forms, indications, dosages or other changes or extensions to the marketing authorisation, or an authorisation which is part of the underlying authorisation, all such marketing authorisations resulting from the extension to the underlying authorisation (new indication, new strength, new pharmaceutical form and method of administration and dosage, and in the case of veterinary medicinal products also addition of a new species) shall be treated as part of the same marketing authorisation.

Article 42
(Refused issue of marketing authorization)
(1) The marketing authorization shall be withheld if, during the examination of the documents and particulars, the authority competent for medicinal products establishes that:
- The risk/benefit balance of the medicinal product is not favourable,
- The applicant did not provide sufficient evidence in support of the quality, safety and therapeutic efficacy of the medicinal product,
- Its qualitative and quantitative composition is not in compliance with the documentation, or
- The label or the package insert, submitted by the applicant, is not in accordance with this Act and the regulations issued on the basis hereof.
(2) The marketing authorization shall also be withheld if the authority competent for veterinary medicinal products establishes that:
- The efficacy of the medicinal product is insufficiently substantiated or that the medicinal product is not efficient,
- The withdrawal period recommended by the applicant is not long enough to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer, or is insufficiently substantiated,
- The veterinary medicinal product is offered for sale for a use prohibited under other EU provisions, or
- The veterinary medicinal product is intended for use in one or more species of food producing animals and contains one or more active substances not stated in Annexes I, II or III of the Regulation 2377/90/EEC.
Article 43
(Refused issue of marketing authorization for traditional medicinal product)
The issue of marketing authorization for traditional herbal medicinal product shall be refused if at least one of the following conditions is fulfilled:
- That its qualitative and quantitative composition is not as declared;
- That its therapeutic indications are not in line with the prescribed conditions;
- That the medicinal product could be harmful in normal use;
- That the data on the traditional use of medicinal product are insufficient; in particular, the pharmacological effects or efficacy of the medicinal product are not probable on the basis of long-term use and experience;
- That the quality of the medicinal product is not sufficiently evidenced.

Article 44
(Data on the placement of medicinal products on the market)
(1) The marketing authorisation holder, the holder of marketing authorisation for parallel imported medicinal product and the wholesaler providing parallel distribution of medicinal product shall inform the authority competent for medicinal products, in writing, of the actual beginning of distribution of the medicinal product in the Republic of Slovenia.
(2) The marketing authorisation holder referred to under the previous paragraph shall be obliged to inform the authority competent for medicinal products on any temporary or permanent suspension of such marketing or interrupted supply of such medicinal product at least two months before adopting a decision on suspension of such marketing, except in the case of force majeure.
(3) If requested by the authority competent for medicinal products, the marketing authorisation holder must submit data on the volume of sales and any data available to the holder concerning the scope of medicinal products issued on prescription.
Article 45
(Roll-out period)
(1) If the medicinal product has not been marketed for three consecutive years after the issue of marketing authorisation, such authorisation shall be cancelled.
(2) Notwithstanding the provisions of the previous paragraph, the authority competent for medicinal products shall be entitled not to cancel marketing authorisation in exceptional well-justified cases and for the needs of protecting public health even if the medicinal product has not been actually marketed for three consecutive years after the issue of marketing authorisation.
Article 46
(Changed conditions of marketing authorisation)
(1) After a marketing authorisation has been issued, the authorization holder must, in respect of the methods of manufacture and control, take account of scientific and technical progress and introduce any changes that may be required to enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods. Before introducing any changes, the authority competent for medicinal products must be informed of any new information that could impact the change of marketing authorisation or the change of documentation on medicinal product.
(2) Marketing authorisation holder must inform the authority competent for medicinal products of any data that could impact the assessment of the risk/benefit balance and particularly of any measures, restrictions or prohibitions introduced by other countries.
(3) The authority competent for medicinal products shall accept or refuse the application for marketing authorisation within the deadlines and according to the procedure stipulated by the Regulation 1084/2003/EC.
(4) The competent minister shall determine the documentation and the detailed conditions for dealing with variations or supplements to the marketing authorisation.

Article 47
(Extension of marketing authorisation)
(1) The holder of a marketing authorisation must, no later than six months prior to its expiry, file an application for renewing marketing authorisation.
(2) The validity of marketing authorisation can be extended after the expiry of the five-year period on the basis of the application for extending the marketing authorisation and reassessment of the risk/benefit balance.
(3) The authority competent for medicinal products shall adopt a decision on the extension of marketing authorisation within 90 days of receiving a complete application.
(4) Once the marketing authorisation has been extended for the first time, it shall, as a rule, be valid for an indefinite period of time or until the reasons stipulated hereby no longer exist. The authority competent for medicinal products shall be entitled to decide that another extension of marketing authorisation is required in exceptional cases, for the needs of protecting public health and, providing an explanation for the marketing authorisation holder.
(5) Notwithstanding the provisions of the previous paragraphs, the authority competent for medicinal products shall accept or refuse the application for the extension of marketing authorisation according to the mutual recognition procedure or the decentralised procedure on the basis of the assessment report compiled by the reference Member State.
(6) The competent minister shall determine more specific conditions and contents of the documentation required for extension of marketing authorisation.
Article 48
(Cancellation of and amendments to marketing authorisation for medicinal products for human use ex officio)
(1) The marketing authorization shall be cancelled, withheld or amended if the authority competent for medicinal products for human use establishes that:
- The medicinal product is harmful in normal use;
- The therapeutic efficacy is lacking, i.e. when it is established that therapeutic results cannot be obtained with the medicinal product;
- The risk/benefit balance of the medicinal product is not favourable in the scope of normal use;
- Its qualitative and quantitative composition is not as declared;
- The medicinal product was marketed contrary to the provisions of the marketing authorisation; or
- The medicinal product was marketed contrary to this Act and the regulations issued on the basis hereof or the EU regulations on medicinal products.
(2) Marketing authorisation shall also be suspended, suspended or amended if it is subsequently established that the particulars supporting the application are incorrect, on the basis of applicable regulations, or have not been submitted or supplemented in accordance with such regulations, or where the prescribed controls have not been carried out.
(3) The authority competent for medicinal products shall cancel or suspend the marketing authorisation for a group of medicinal products or all medicinal products for use in human medicine which are produced on the basis of a certain manufacturing authorisation if any of the requirements of such manufacturing authorisation is not met and cancel or suspend the manufacturing authorisation for such group of medicinal products or all medicinal products.
Article 49
(Cancellation of and changes to marketing authorisation for veterinary medicinal products ex officio)
(1) The marketing authorization shall be cancelled, suspended or amended if the authority competent for veterinary medicinal products establishes that:
- The assessment of the risk/benefit balance of such medicinal product is unfavourable in terms of the conditions of use as stated in the marketing authorisation, taking into account above all health and wellbeing of animals and safety of consumers in the event of marketing authorisation for use in zootechnics;
- The medicinal product does not have any therapeutic effect on the species of animal for which the treatment is intended;
- Its qualitative and quantitative composition is not as stated;
- The recommended withdrawal period is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer;
- The medicinal product is offered for sale or advertised for a use prohibited under other applicable regulations;
- The data in the application are incompliant, incorrect, or have not been supplemented in accordance with the regulations, or where the prescribed controls have not been carried out;
- The particulars from the documentation have not been changed in line with the scientific and technological development in the field of medicinal product manufacturing and control;
- The competent authorities have not been submitted new information on any prohibitions or restrictions of the use of medicinal product in any country or new information on the risk/benefit balance;
- The medicinal product was marketed contrary to the provisions of the marketing authorisation; or
- The medicinal product was marketed contrary to this Act and the regulations issued on the basis hereof or the EU regulations on medicinal products.
(2) The authority competent for medicinal products shall cancel or suspend the marketing authorisation for a group of medicinal products or all veterinary medicinal products which are produced on the basis of a certain manufacturing authorisation if any of the requirements of such manufacturing authorisation is not met and cancel or suspend the manufacturing authorisation for such group of medicinal products or all medicinal products.
Article 50
(Sale of medicinal product following the amendment or expiry of marketing authorisation)
(1) A medicinal which has been manufactured or imported prior to the expiry of or amendment to the marketing authorisation may be marketed even after the expiry of the period for which its marketing authorisation was granted until the expiry date of such medicinal product, but for no longer than 18 months after the expiry of or amendment to the marketing authorisation, with the exception of measures taken in accordance with Articles 83 or 84 hereof.
(2) It is prohibited to place on the market any medicinal product whose shelf life has expired or whose quality, safety and efficacy has been found to be deficient.
Article 51
(Documentation as trade secret)
The documentation enclosed in the application for the issue of, amendment to or extension of a marketing authorisation is the property of the applicant and a trade secret, with the exception of data stated in the marketing authorisation and including the summary of product characteristics of the medicinal product, its instructions for use and data on the packaging.
Article 52
(Publication of lists)
(1) Lists of medicinal products for which a marketing authorisation has been issued and lists of medicinal products whose validity has expired or whose marketing authorisation has been amended, extended, suspended or cancelled shall be published by the authority competent for medicinal products in the Official Gazette of the Republic of Slovenia.
(2) The competent minister shall prescribe the contents of the publication stated in the previous paragraph.
Article 53
(Transfer of marketing authorisation)
(1) A marketing authorisation holder may transfer its marketing authorisation to another legal entity or natural person who meets the conditions stipulated hereunder.
(2) The competent minister shall prescribe the procedure for the transfer of marketing authorisation stipulated in the previous paragraph and the necessary documentation and procedure for verifying the prescribed conditions and other necessary evidence.
III. TESTING OF MEDICINAL PRODUCTS
Article 54
(Testing of medicinal products)
(1) Prior to being placed on the market, a medicinal product must undergo analytical and non-clinical pharmacotoxicological tests as well as clinical trials in order to obtain the assessment of its quality, safety and efficacy.
(2) A medicinal product shall undergo analytical and pharmacotoxicological tests as well as clinical trials even if it has already been granted a marketing authorisation or has been marketed, if such testing is performed with the purpose of regular control of medicinal products or for acquiring additional data on that product.
(3) Analytical and non-clinical pharmacotoxicological tests as well as clinical trials may be carried out by legal entities and natural persons (hereinafter: the medicinal product investigation institutions) who satisfy the requirements in terms of staff, facilities, equipment and principles of good practices and hold the licence for performing such activities.
(4) Data on analytical and non-clinical pharmacotoxicological tests as well as clinical trials represent a constituent part of the documentation for obtaining the marketing authorisation.
(5) Analytical and non-clinical pharmacotoxicological tests as well as clinical trials must correspond to contemporary scientific knowledge and principles of good practices. They must be described in sufficient detail so that the tests and trials can be repeated in order to ensure data comparability.
(6) The competent minister shall determine more detailed methods and procedures of analytical and non-clinical pharmacotoxicological tests as well as clinical trials and the requirements which the medicinal product investigation institutions must satisfy as well as the procedures and methods of their verification.
Article 55
(Analytical testing)
Analytical testing shall mean pharmaceutical, chemical and biological quality testing of a medicinal product in compliance with the principles of good laboratory practice and in accordance with the data contained in the documentation for obtaining the marketing authorisation or medicinal product specifications.
Article 56
(Non-clinical pharmacotoxicological testing)
(1) Non-clinical pharmacotoxicological testing shall mean the procedure for establishing the safety of a medicinal product and shall be carried out in compliance with the principles of good laboratory practice and in accordance with the data contained in the documentation for obtaining the marketing authorisation.
(2) Non-clinical pharmacotoxicological testing must define pharmacodynamic, pharmacokinetic and toxicological properties demonstrated on laboratory animals and foresee any possible effects in human beings or target animal species.
(3) The non-clinical pharmacotoxicological testing concerning medicinal products for use in veterinary medicine must provide data on metabolism, kinetics, elimination of medicinal product residues and routine analysis methods that can be applied to determine the level of such residues.
Article 57
(Clinical trials of medicinal products)
(1) Clinical trials of human medicinal products shall mean trials involving healthy and sick human beings, with the purpose of demonstrating or ascertaining any pharmacological or other pharmacodynamic effects of the investigated medicinal product, demonstrating any adverse reactions to it, or investigating its absorption, distribution, metabolism and elimination during investigation with a view to proving its safety and efficacy.
(2) Clinical trials of veterinary medicinal products shall mean the organised study of the effect of a medicinal product on an animal organism with the purpose of demonstrating or ascertaining any pharmacological or other pharmacodynamic effects of the investigated veterinary medicinal product, demonstrating any adverse reactions to it, or investigating its absorption, distribution, metabolism, elimination and residues during investigation with a view to proving its safety and efficacy in target animal species.
Article 58
(Prerequisites for clinical trial)
(1) Medicinal products can be submitted to clinical trials only after the submission of the results on analytical and non-clinical pharmacotoxicological testing of a medicinal product and in the event of investigating a medicinal product that has no impact on the subject's germ line genetic identity.
(2) The procedure for the clinical testing of a medicinal product which is described in the documentation submitted for obtaining marketing authorisation must correspond to the requirements stipulated under Article 54 hereof and the principles of good clinical practice in clinical testing and principles of human medical and veterinary ethics as well as the mandatory and guaranteed protection of personal data.
Article 59
(Conditions for the commencement of a clinical trial)
(1) The applicant for a clinical trial can be either the sponsor of such clinical trial or its representative if the sponsor’s registered office is located outside the European Union in which case the representative’s registered office must be located in the European Union.
(2) Clinical trial can commence once the conditions stipulated by this Act and any regulations arising hereof are fulfilled.
(3) Written authorisation must be issued by the authority competent for medicinal products before commencing clinical trials involving human medicinal products for gene therapy, somatic cell therapy including xenogenic cell therapy and all medicinal products containing genetically modified organisms.
(4) Prior to the commencement of clinical trials of other medicinal products such trials must be notified and the trial can begin if the authority competent for medicinal product does not object within the foreseen deadline.
Article 60
(Liability insurance)
Prior to the commencement of the clinical trial, the applicant for such trial must take up liability insurance for any possible damage resulting from the trial.
Article 61
(Supervision of clinical trial)
Clinical trials performed hereunder shall be supervised by pharmaceutical supervisors holding a university degree in pharmacy, human or veterinary medicine, having additional skills and experience with good clinical practice and meeting the conditions stipulated under the second and the third indent of the first paragraph of Article 102 hereof.
Article 62
(Approval and notification of a clinical trial)
(1) The authority competent for medicinal products shall decide on the applications for approval or notification of a clinical trial. The Committee for Clinical Trials shall issue an opinion on the proposed or notified clinical trial.
(2) The applicant must enclose with the application for a clinical trial of a human medicinal product the opinion of the National Medical Ethics Committee within the ministry competent for health.
(3) The authority competent for medicinal products shall adopt a decision on the application for a clinical trial within 60 days of receiving a complete application. In the case of medicinal products obtained through a biotechnology process, the said deadline can exceptionally be extended for further 30 days. If the application concerns human medicinal products for xenogenic cell therapy no deadline will be laid down for the issue of a decision by the authority competent for medicinal products. Clinical trial can commence once the applicant has received the decision on the approval of such clinical trial.
(4) The authority competent for medicinal products shall adopt a decision on the notification of a clinical trial within 60 days of receiving a complete notification. If there is no response from the competent authority it shall be deemed that the notification has been approved and the clinical trial can commence.
Article 63
(Changes in clinical trial)
(1) In the case of any material changes to ongoing clinical trials, the sponsor must inform the authority competent for medicinal products thereof.
(2) The notified change can be introduced if the authority competent for medicinal products does not issue a negative decision within 35 days of receiving a complete application for such change. In exceptional cases, this period of time may be extended to 60 days.
Article 64
(Discontinuation of a clinical trial)
The authority competent for medicinal products may, for the purpose of protecting public health or health of investigated subjects, order that a trial be temporarily or permanently discontinued.
Article 65
(Payment of expenses arising from trials)
If a clinical trial of a medicinal product with marketing authorisation or marketing authorisation for parallel imported medicinal product is required by an authority competent for medicinal products in order to verify the risk/benefit balance, the costs shall only be borne by the applicant if it turns out that the safety and efficacy correspond to the requirements of the marketing authorisation. In all other events, the costs shall be paid by the marketing authorisation holder.
IV. MANUFACTURING AUTHORISATION FOR MEDICINAL PRODUCTS
Article 66
(Manufacturing of medicinal products)
(1) Legal entities or natural persons may manufacture medicinal products only after they have been granted a manufacturing authorisation and in compliance with such authorisation. The authorisation shall comprise the manufacturing of medicinal products and their sales to wholesalers that have obtained appropriate marketing authorisation and shall be required in the following cases:
- Individual manufacturing processes or the entire production process;
- Individual manufacturing or production unit;
- Individual pharmaceutical forms;
- Manufacturing of active substances;
- For excipients, based on the applicable regulations.
(2) The provisions laid down in the preceding paragraph shall also apply to the manufacturers of medicinal products intended exclusively for exports or clinical trials.
(3)Importers of medicinal products from third countries must also hold manufacturing authorisations.
(4) Manufacturing authorisation shall also include authorisation to distribute by wholesale the medicinal products covered by that authorisation.
Article 67
(Manufacturing conditions)
Legal entities and natural persons manufacturing medicinal products must meet the following conditions:
1. Given the volume and complexity of their medicinal product manufacture, to employ an adequate number of professionals holding university degrees and with an appropriate specialisation in pharmacy, chemistry, chemical technology, medicine, stomatology, veterinary medicine or other appropriate discipline with adequate skills depending on the subject of operations.
2. They must have concluded a contract with an adequately skilled person in charge of releasing the batch of medicinal products to the market who is available at all times. In the case of corporations and groups of companies, it is possible to appoint such person only in one of the members of the group, provided that there exists adequate legal and organisational delimitation of responsibilities and competencies. Such qualified person must have university education in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. The programme of such studies must comprise skills defined by the second paragraph of Article 49 of the Directive 2001/83/EC or the second paragraph of Article 53 of the Directive 2001/82/EC. If the programme of studies does not comprise either of those skills, the qualified person must submit appropriate evidence of having obtained such skills. The qualified person must also have adequate work experience as defined by the third paragraph of Article 49 of the Directive 2001/83/EC or the third paragraph of Article 53 of the Directive 2001/82/EC.
3. They must be equipped with adequate facilities, devices and equipment for the manufacture, control, storage and dispatching and of medicinal products in accordance with the principles of good manufacturing practice.
4. The activity must be performed in accordance with the principles of good manufacturing practice.
5. Only active substances produced in line with good manufacturing practice for starting materials and excipients must be used as starting materials, in accordance with the regulations.
6. They must only provide medicinal products for which marketing authorisation has been issued or medicinal products manufactured or imported in the scope of such marketing authorisation and in line with the applicable regulations.
7. The qualified person referred to under Point 2 hereunder must have the possibility to independently perform its tasks and must have access to all necessary means.
Article 68
(Procedure for obtaining authorisation)
(1) The procedure for the issue of manufacturing authorisation shall be initiated on the basis of an application submitted by a legal entity or a natural person. The application for obtaining a manufacturing authorisation shall contain evidence on the fulfilment of conditions referred to under the previous Article.
(2) The authority competent for medicinal products shall issue or refuse to issue the manufacturing authorisation within 90 days of receiving a complete application on the basis of an opinion issued by the pharmaceutical supervision.
(3) The authority competent for medicinal products may require additional documents or data needed for adopting the decision on the issue of manufacturing authorisation. The procedure shall be suspended until the fulfilment of requirements.
(4) The competent minister shall determine in greater detail the contents of the application and specify the conditions and the procedures for establishing that such conditions for obtaining the marketing authorisation are met as well as the substance and form of the required documentation.
(5) The documentation from the application for obtaining the manufacturing authorisation is a business secret if defined as such by the applicant, in accordance with the regulations.
Article 69
(Certificate of good manufacturing practice)
(1) The manufacturing authorisation holder may require from the authority competent for medicinal products to be issued a certificate of good manufacturing practice.
(2) The procedure for granting or cancelling the certificate of good manufacturing practice shall be prescribed by the competent minister.
Article 70
(Changed conditions for issuing manufacturing authorisations)
(1) The marketing authorisation holder must inform the authority competent for medicinal products of any change in the conditions stipulated under Article 67 hereof which served as the basis for the issue of marketing authorisation.
(2) The deadline for issuing the decision shall be 30 days except in case a specific declaratory procedure is necessary for verifying conditions based on examination. In such cases the deadline for issuing the decision shall be 90 days.
(3) The competent minister shall determine in greater detail the contents of the application for the change of conditions on the basis of which the manufacturing authorisation has been issued and specify the conditions and the procedures for establishing that such conditions for issuing manufacturing authorisation are met.

Article 71
(Cancellation of manufacturing authorisation)
A manufacturing authorisation shall be suspended or cancelled, should the authority competent for medicinal products ascertain that the manufacture of medicinal products no longer satisfies the requirements defined in Article 67 herein and regulations arising hereto.
V. LABELLING AND PACKAGE INSERT
Article 72
(Labelling and package insert)
(1) Information about each medicinal product placed on the market must be written in the Slovene language on its outer packaging or, where there is no outer packaging, on the immediate packaging. Identical information may be given in one or more foreign languages. Data must be legible.
(2) In every medicinal product placed on the market there must be a package insert containing instructions for use in the Slovene language in line with the summary of product characteristics, unless the information required by a regulation is given on the outer packaging or, where there is no outer packaging, on the immediate packaging. Data must be legible and understandable for the user.
(3) Notwithstanding the provisions of the first and the second paragraph hereunder the authority competent for medicinal products may exceptionally allow the use of packaging in a foreign language with a label in the Slovene language and the packaging insert in a foreign language, provided that the insert is enclosed with the medicinal product in the Slovene language in the prescribed manner.
(4) The name of the medicinal product on the packaging must also be printed in Braille. Marketing authorisation holder must ensure that the packaging insert is available in the forms suitable for the blind and the partially sighted, if required by competent patient organisations.
(5) The competent minister shall prescribe a more detailed manner of labelling medicinal products, the form and contents of package insert and the manner of using the labels, special labelling conditions and package inserts for individual medicinal products or groups of medicinal products.
VI. MARKETING OF MEDICINAL PRODUCTS
Article 73
(Wholesale)
(1) Wholesalers in medicinal products may only buy medicinal products from legal entities and natural persons holding appropriate manufacturing or wholesale marketing authorisation.
(2) Wholesalers in medicinal products may only sell medicinal products to legal entities and natural persons holding appropriate retail or wholesale marketing authorisation and pharmacies.
(3) Notwithstanding the provision of the previous paragraph, wholesalers may sell medicinal products directly to health institutions, legal entities or natural persons holding an authorisation issued by the competent authority for performing medical activity, provided that they have established the system for receiving, storing and tracing medicinal products which has been appropriately verified by the competent authority, and appointed a qualified person to receive, store and ensure traceability of medicinal products who holds a diploma, degree or another university or equivalent certificate in the field of pharmaceutical science.
(4) Notwithstanding the provision of the second paragraph hereunder, the wholesalers may sell veterinary medicinal products to veterinary and other organisations which perform veterinary activity in line with the veterinary regulations and authorised manufacturers of medicated feedingstuffs in accordance with the regulations and in the scope covered by their manufacturing authorisation.
(5) Medicinal products referred to in the third paragraph hereunder may only be used for the provision of health services arising from the abovementioned authorisation for performing medical activity.
Article 74
(Conditions for wholesalers)
(1) The wholesale of medicinal products may be undertaken by legal entities and natural persons holding an authorisation issued by the competent authority for performing medical activity and satisfying the following requirements:
1. Have at their disposal the services of professionals, based on contractual relationship, holding a university degree in pharmacy or experts in other disciplines, if necessary.
2. Appoint from among the experts mentioned in the previous point a person in charge of receiving, storing, issuing and transporting medicinal products as well as examining documentation that enables traceability of medicinal products. Such qualified person must hold a university degree in pharmacy.
3. Have at their disposal adequate facilities and equipment, depending on the type of medicinal product that is the subject of wholesale trade.
4. Keep appropriate documentation so as to enable the immediate withdrawal of a medicinal product from the market and resolve complaints.
5. Organise work in accordance with the principles of good distribution practice.
6. Guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a reasonably short time over the whole of the area in question.
7. Have established quality assurance system.
8. Meet the conditions for performing trading activity in accordance with the applicable trade regulations.
(2) If the responsible person stipulated by Point 2 of the previous paragraph does not have a university degree in pharmacy, such person must have obtained additional skills defined by the second paragraph of Article 49 of the Directive 2001/83/EC or the second paragraph of Article 53 of the Directive 2001/82/EC. If the programme of studies does not comprise either of those skills, the qualified person must submit appropriate evidence of having obtained such skills. The qualified person must also have adequate work experience as defined by the third paragraph of Article 49 of the Directive 2001/83/EC or the third paragraph of Article 53 of the Directive 2001/82/EC.
(3) Legal entities or natural persons having obtained the marketing authorisation for wholesaling of medicinal products in another EU Member State and intending to wholesale medicinal products in the Republic of Slovenia can start performing such activity in the Republic of Slovenia once they have notified themselves with the authority competent for medicinal products in accordance with the procedure prescribed by the competent minister.
(4) A distribution authorisation holder must obtain the manufacturing authorisation and meet the conditions stipulated by Article 67 hereof if they plan to manufacture or import medicinal products besides distributing them through wholesale trade.
(5) The competent minister shall determine in greater detail the requirements for the wholesalers of medicinal products as well as the notification procedure in agreement with the minister competent fro trade.
(6) In view of the type of medicinal products in wholesale, the competent minister may prescribe different conditions of wholesale for certain medicinal products.
Article 75
(Issue of authorisation)
(1) The procedure for the issue of distribution authorisation shall be initiated on the basis of an application submitted by a legal entity or a natural person. The application for obtaining a manufacturing authorisation shall contain evidence on the fulfilment of conditions referred to under Article 74 hereof.
(2) The authority competent for medicinal products shall decide on the issue of distribution authorisation within 90 days of receiving a complete application on the basis of an expert opinion issued by the pharmaceutical supervision concerning the fulfilment of conditions.
(3) The authorisation referred to in the previous paragraph may be issued for a limited time or under certain conditions and can be suspended or cancelled should the competent authority ascertain that the holder of distribution authorisation no longer satisfies the prescribed requirements.
Article 76
(Imports)
(1) Medicinal products shall be imported by the manufacturing authorisation holders and wholesalers who, besides the conditions stipulated by Article 74 hereof also meet the conditions prescribed for the manufacturers of medicinal products in respect to the parts of manufacturing procedure they carry out.
(Wholesalers and manufacturing authorisation holders importing medicinal products from third countries and not having themselves the appropriate facilities, equipment and devices for controlling the quality of each imported batch of medicinal product, can enter into a contractual relationship with a legal entity or natural person for the provision of the services of analytical testing of medicinal products, provided that such entity or person holds the authorisation of the authority competent for medicinal products to perform analytical testing of medicinal products.
(3) The batches of medicinal products which have undergone such controls in another EU Member State shall be exempt from the controls prior to their marketing in the Republic of Slovenia, provided that they are accompanied by the control reports signed by the qualified person in charge of batch release.
(4) In the case of medicinal products imported from a country that has entered into Mutual Recognition Agreement with the European Union for the area of medicinal products, the analysis certificate obtained in the exporting country shall be recognised.
Article 77
(Entry and imports of medicinal products)
(1) Entry and imports of medicinal products with:
- Marketing authorization,
- Marketing authorisation for parallel imported medicinal product, or
- Authorisation for clinical trial or adequately notified clinical trial,
need not meet the conditions stipulated by this Act.
(2) Notwithstanding the provisions of the previous paragraph, the entry and import of medicinal products shall only be allowed on the basis of entry authorisation or import authorisation issued by the authority competent for medicinal products within 30 days after receiving a complete application in the following cases:
1. Immunological serums, vaccines, blood products, radiopharmaceuticals;
2. Medicinal products without marketing authorisation in cases of emergency for treatment proposed by a legal entity performing tertiary medical activity or a competent veterinarian of the veterinary organisation and on the basis of personal responsibility of a doctor or veterinarian in charge of individual cases of treatment;
3. Medicinal products stipulated by Article 15 hereof without a marketing authorisation;
4. Medicinal products intended for research and development work at the responsibility of the institution performing such research and development work.
(3) The application for obtaining the entry authorisation referred to in the previous paragraph can be submitted by a wholesaler and for obtaining the import authorisation by a person meeting the requirements for the import of medicinal products.
(4) The competent minister shall determine in greater detail the requirements, methods and procedures governing the entry and imports referred to in the previous paragraph.
Article 78
(Parallel imports of medicinal products)
(1) The procedure for obtaining a marketing authorisation for parallel imported medicinal product shall be initiated on the basis of an application submitted by the importer who is a wholesaler and is not in a business relationship for the marketing of such medicinal product with the holder of marketing authorisation. The authority competent for medicinal products shall issue the marketing authorisation for parallel imported medicinal products within 60 days of receiving a complete application.
(2) The competent minister shall lay down more detailed conditions, method and procedure for obtaining the marketing authorisation for parallel imported medicinal products.
Article 79
(Retail)
(1) Retail trade in medicinal products for human use, accompanied by adequate expert support and advice, shall be carried out in pharmacies and specialised stores, while veterinary medicinal product shall also be sold in veterinary organisations, together with the service provided.
(2) Notwithstanding the provisions of the previous paragraph, only those medicinal products can be sold in specialised retail stores which are not subject to medical or veterinary prescription and are authorised by the authority competent for medicinal products.
(3) When defining medicinal products that can be sold in specialised retail stores, the authority competent for medicinal products may introduce certain restrictions concerning the strengths, packaging sizes and number of units sold.
(4) The authority competent for medicinal products shall only authorise the sales of those medicinal products in specialised retail stores which have a favourable risk/benefit balance and an acceptable pharmacovigilance and toxicovigilance profile.
(5) Medicinal products in specialised retail stores may only be sold to adult persons.
(6) The method and place of issuing medicinal products shall be defined in the relevant marketing authorisation.
(7) Homeopathic medicinal products may only be issued in pharmacies, while veterinary homeopathic medicinal products may also be sold in veterinary organisations, together with the service provided.
(8) Issue based on self-service shall only be allowed in pharmacies and specialised retail stores and shall be limited to medicinal products referred to in the second paragraph hereunder which are of herbal origin.
(9) Sales of medicinal products over the Internet, accompanied by adequate expert support and advice, shall be allowed if performed by a holder of an authorisation for performing such pharmaceutical activity who ensures quality and traceability of medicinal products. The ministry competent for health may recognise such authorisations issued by the competent authorities of the EU Member States.
(10) Besides the responsibility of Internet source of a medicinal product, which includes the liability of manufacturer, wholesaler and retailer, the user or buyer of such medicinal product shall also be responsible for any risks and damages incurred through the use of medicinal products obtained from non-traceable Internet sources or sources that do not correspond to the requirements of the previous paragraph.
(11) The competent minister shall determine the manner of issue and the related classification of the medicinal product.
Article 80
(Pharmacies)
Requirements for marketing medicinal products imposed on pharmacies and Internet pharmacies shall be regulated by a separate act.
Article 81
(Specialised stores)
(1) The retail sale of medicinal products in specialised stores may be undertaken by legal entities and natural persons holding an authorisation issued by the competent authority for performing medical activity and satisfying, besides the general conditions for performing the retail sale activity, also the following requirements:
1. They must employ at least one qualified person with at least level V pharmacy education, who has passed the qualifying examination and is put in charge of purchasing, storing and selling medicinal products and keeping documentation and must be available at all times during the store’s business hours.
2. They must dispose of adequate facilities which must be physically separated from the facilities in which other products are sold, and the necessary equipment.
3. They must keep appropriate documentation so as to enable the immediate recall of a medicinal product from the market and resolve complaints.
(2) The procedure for the issue of retail authorisation for the sale of medicinal products in specialised stores shall be initiated on the basis of an application submitted by a legal entity or a natural person.
(3) The authority competent for medicinal products shall issue a retail authorisation for the sale of medicinal products in specialised stores within 90 days of receiving a complete application on the basis of an expert opinion issued by the pharmaceutical supervision concerning the fulfilment of conditions.
(4) The authorisation referred to in the previous paragraph may be issued for a limited time or under certain conditions and can be suspended or cancelled should the competent authority ascertain that the holder of marketing authorisation no longer satisfies the prescribed requirements.
(5) More detailed requirements for marketing medicinal products imposed on specialised shops retailing medicinal products and the procedure for ascertaining their compliance shall be determined by the competent minister in agreement with the minister competent for trade.
VII. PHARMACOVIGILANCE
Article 82
(Pharmacovigilance system)
(1) Reports on adverse reactions to medicinal products for human use shall be collected and assessed by a legal entity meeting the conditions concerning personnel, facilities and equipment and authorised for performing such activity by the competent minister.
(2) A doctor or another health professional who identifies or suspects any adverse reactions to medicinal products for human use shall inform thereof the legal entity referred to in the previous paragraph in accordance with the applicable regulations.
(3) A veterinarian who identifies or suspects any adverse reactions to medicinal products for veterinary use shall inform thereof the marketing authorisation holder in accordance with this Act and the regulations issued on the basis hereof. In the case of unexpected serious adverse reactions in animals and in human beings related to the use of veterinary medicinal products the authority competent for medicinal products shall also be informed, besides the marketing authorisation holder in accordance with this Act and the regulations issued on the basis hereof.
(4) Holders of marketing authorisations must setup and maintain their own pharmacovigilance systems which guarantee collection, evaluation and exchange of data with the legal entity referred to in the first paragraph hereunder and with the bodies competent for medicinal products in the Republic of Slovenia and the European Union as well as other sources, such as the publications of the World Health Organisation and other professional publications. They must compile reports and perform other tasks within the deadlines and in the way stipulated by Articles 103 and 104 of the Directive 2001/83/EC and Articles 74 and 75 of the Directive 2001/82/EC.
(5) Legal entities referred to in the first paragraph hereunder must regularly submit the collected data on adverse reactions and any other significant data concerning safety and efficacy and use of medicinal products as well as the functioning of the pharmacovigilance system to the authority competent for medicinal products.
(6) The authority competent for medicinal products shall identify and evaluate the adverse reactions to medicinal products and other findings about the safety of medicinal products and take measures with the aim of managing and reducing the risks arising from medicinal products, with expert assistance provided by the legal entity stipulated by the first paragraph hereunder, verify the implementation of the pharmacovigilance system by the marketing authorisation holders and perform tasks in accordance with the provisions of Articles 105, 106 and 107 of the Directive 2001/83/EC and Articles 76, 77 and 78 of the Directive 2001/82/EC.
(7) The provisions of this Article shall not apply to homeopathic medicinal products specified in the second paragraph of Article 14 of this Act. The competent minister may prescribe the pharmacovigilance management system for such homeopathic medicinal products.
(8) The competent minister shall determine in greater detail the conditions for the functioning of the pharmacovigilance system.
Article 83
(Measures taken in the event of inappropriate quality of medicinal products)
(1) Legal entities or natural persons, manufacturing or marketing medicinal products must report all events or suspected events regarding inappropriate quality of medicinal products, which could affect the safety or efficacy of the medicinal product, to the authority competent for medicinal products, the marketing authorisation holder and the legal entity or natural person marketing the medicinal products.
(2) The marketing authorisation holder shall be obliged to withdraw the deficient medicinal product from the market or take any other necessary measures as well as inform, regularly and without delay, the authority competent for medicinal products of any activities taken.
(3) The marketing authorization holder shall be obliged to notify the competent authorities of the EU Member States in which the medicinal product is marketed forthwith of any action taken by him to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market or to suspend or cancel the marketing authorisation, together with the reasons for such action if the latter concerns the efficacy of the medicinal product or the protection of public health.
(4)The authority competent for medicinal products shall monitor and, if necessary, direct the activities of the marketing authorisation holder in relation to the measures taken in the event of inappropriate quality of medicinal products and report to the international rapid alert system.
(5) The authority competent for medicinal products shall immediately inform the European Medicines Agency in the case of taking any measures that could influence the protection of public health in the EU Member States and, if necessary, also the World Health Organisation.
(7) The competent minister shall determine in greater detail the measures to be taken in the case of inappropriate quality.
Article 84
(Measures taken in pharmacovigilance cases)
(1) The provisions of the previous Article shall also apply in the cases of increased risk arising from adverse reactions that could be harmful for the health of people or animals or impact the risk/benefit balance of the medicinal product and should be reported to the international rapid alert system.
(2) The competent minister shall prescribe more detailed measures to be taken in the cases stated in the previous paragraph.
VIII. ADVERTISING OF MEDICINAL PRODUCTS
Article 85
(Advertising of medicinal products)
Advertising of medicinal products shall mean any form of information, including door-to-door information, publication or inducement designed to promote the prescription, issue, sale or consumption of medicinal products.
Article 86
(Terms and conditions of advertising)
(1) The marketing authorisation holders may advertise medicinal products only in accordance with the provisions of this Act and the regulations issued on the basis of this Act.
(2) It is prohibited to advertise medicinal products which have not been granted a marketing authorisation.
(3) All parts of the advertising of a medicinal product must comply with the summary of product characteristics.
(4) Advertising of medicinal products must encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties, and may not be misleading.
Article 87
(Advertising of medicinal products to the general public)
(1) It is only allowed to advertise in the mass media medicinal products dispensed without prescription.
(2) It is prohibited to advertise to the general public the following:
- Medicinal products dispensed only on prescription;
- Medicinal products containing psychotropic or narcotic substances within the meaning of international conventions, such as the United Nations Convention on narcotic drugs of 1961 and the United Nations Convention on psychotropic substances of 1971.
(3) The advertising of a medicinal product to the general public shall not contain any material which:
- Gives the impression that a medical or veterinary consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail;
- Suggests that the effects of taking the medicine are absolutely guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicinal product;
- Suggests that the health of the person or animal can be enhanced by taking the advertised medicine;
- Suggests that the health of the person or animal could deteriorate by not taking the advertised medicine; this prohibition shall not apply to the vaccination programmes;
- Is directed exclusively or principally at children;
- Refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products;
- Suggests that the medicinal product is a foodstuff, cosmetic or other consumer product;
- Suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural;
- Could, by a description or detailed representation of a case history, lead to erroneous self-diagnosis;
- Refers, in improper, alarming or misleading terms, to claims of recovery; or
- Uses, in improper, alarming or misleading terms, pictorial representations of changes in the human or animal body caused by disease or injury, or of the action of a medicinal product on the human or animal body or parts thereof;
(4) Direct distribution of medicinal products to the end users for promotional purposes shall be prohibited.
Article 88
(Advertising of medicinal products to the expert community)
(1) Holders of marketing authorisations may advertise medicinal products with marketing authorisation in scientific literature, professional journals and other professional publications, as well as directly inform experts who prescribe or dispense medicinal products.
(2) Where medicinal products are being promoted to expert community, i.e. persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine, veterinary medicine or pharmacy. The value of gifts, pecuniary advantages or small benefits in kind may not exceed the value prescribed for civil servants.
(3) Organisation and implementation of promotional meetings must be strictly limited to the professional purpose of the meeting which includes obtaining of new skills and knowledge on new medicinal products and may only be provided to persons authorised to prescribe and issue medicinal products.
(4) Marketing authorisation holders, manufacturers of medicinal products, legal entities and natural persons acting on behalf of manufacturers and legal entities and natural persons marketing medicinal products, as well as subsidiaries of foreign manufacturers may enable persons who prescribe or issue medicinal products to acquire knowledge on new medicinal products in scientific and expert meetings, however, only in the scope of restrictions referred to in the second and the third paragraph hereunder.
(5) Persons qualified to prescribe or supply medicinal products shall not solicit or accept any inducement prohibited under the second and the third paragraph hereunder.
(6) The marketing authorization holder shall be obliged to establish a scientific service for advertising medicinal products with medical experts to advertise medical experts to persons prescribing and issuing medicinal products. Such experts for human medicinal products must hold a university degree in pharmacy or human medicine or a university degree in natural sciences or biomedicine with additional skills in medicinal products. Such experts for veterinary medicinal products must hold a university degree in pharmacy or veterinary medicine or a university degree in natural sciences or biomedicine with additional skills in medicinal products.
(7) The competent minister shall determine in greater detail the conditions and method of advertising.
Article 89
(Advertising in extraordinary cases)
(1) The competent minister may, by way of exception and in the interest of the general public, with a view to preventing an epidemic, an epizootic, or in case of a natural disaster or in other similar emergencies, allow or approve information about the use of certain medicinal products to be distributed to the mass media.
(2) In the cases referred to in the previous paragraph concerning veterinary medicinal products, the competent minister shall allow or authorise informing on the use of certain medicinal products in public media in agreement with the minister competent for veterinary medicine.
(3) The authority competent for medicinal products may allow advertising of medicinal products used in vaccination programmes to the general public.
Article 90
(Official records of the authority competent for medicinal products)
(1) The authority competent for medicinal products shall keep official records of:
1. Data on medicinal products arising from marketing authorisation based on the type and classification of medicinal products (name, pharmaceutical form, strength, packaging, marketing authorisation holder, manufacturer, applicable price);
2. Data on medicinal products arising from marketing authorisation for parallel imported medicinal products (name, pharmaceutical form, strength, packaging, holder of marketing authorisation for parallel imported medicinal products, manufacturer, applicable price);
3. Data on medicinal products arising from entry or import authorisation (name, pharmaceutical form, strength, packaging, entry authorisation holder, manufacturer);
4. Data on marketing authorization holder (name and legal form of organisation, registered office, name and surname of qualified person responsible for pharmacovigilance);
5. Data on manufacturing authorization holder (name, registered office and legal form of organisation, name and surname of qualified person in charge of releasing the batch of medicinal products to the market);
6. Data on distribution authorization holder (name and legal form of organisation, registered office, name and surname of qualified person in charge of receiving, storing and transporting medicinal products as well as examining documentation);
7. Data on notified foreign wholesalers (name and legal form of organisation, registered office, name and surname of qualified person in charge of receiving, storing and transporting medicinal products as well as examining documentation);
8. Data on retail authorization holder (name and legal form of organisation, registered office, name and surname of qualified person in charge of purchasing, storing and selling medicinal products as well as keeping documentation);
9. Data on the holders of marketing authorisations for parallel imported medicinal products (name and legal form of organisation, registered office, name and surname of qualified person responsible for pharmacovigilance).
(2) The authority competent for medicinal products shall publish professional and general informative publications in its areas of competence.
IX. OFFICIAL QUALITY CONTROL OF MEDICINAL PRODUCTS
Article 91
(Official control laboratory)
(1) Official control laboratory shall mean a legal entity or a natural person complying with the requirements set in the third paragraph of Article 54 hereof, appointed by the competent minister for verifying whether the official quality of medicinal products, which is a member of the European network of official control laboratories or which annually participates in the intra-laboratory verification organised by the European Directorate for the Quality of Medicines and the results achieved are in compliance with the organiser’s requirements.
(2) The competent minister shall prescribe more detailed conditions regarding personnel, facilities, equipment and fulfilment of standards prescribed for quality control of medicinal products, compliance with the principles and guidelines of good laboratory practice and management of quality system.
Article 92
(Types of official controls)
(1) Official quality control of a medicinal product shall mean the process in which the official control laboratory establishes the quality of medicinal product on the basis of analytical testing of certificates, packaging, package insert or other documents.
(2) This Act stipulates the following types of official quality controls of a medicinal product:
- Regular quality controls of all medicinal products, performed in respect to each medicinal product ex officio at least once in five years for each of its pharmaceutical forms and strengths;
- Extraordinary quality controls of medicinal products i.e. quality controls upon the request of the authority competent for medicinal products or pharmaceutical supervisor;
- Special quality controls performed prior to the placing on the market of each batch of risk medicinal products, i.e. immunal serums and vaccines, immunoglobulins and blood products on the basis of the proposal submitted by the marketing authorisation holder or the applicant stipulated under the third paragraph of Article 77 hereof, if no marketing authorisation has been issued for the medicinal product;
- Quality controls of each first batch of medicinal product before it is put on the market, carried out on the basis of the proposal submitted by the marketing authorisation holder, in the case of medicinal products imported from third countries which have not entered into Mutual Recognition Agreement with the EU;
- Quality controls of medicinal products required by the authority competent for medicinal products in the framework of the procedure for obtaining marketing authorisation;
- Quality controls of each first batch of medicinal product with marketing authorisation for parallel imported medicinal product.
Article 93
(Medical report)
(1) The official control laboratory shall issue a medical report on the performed quality control of a medicinal product with assessed quality of the medicinal product which shall be submitted to the authority competent for medicinal products, the pharmaceutical supervision, the marketing authorisation holder or the applicant requesting control.
(2) The samples and costs of official quality control specified in the second paragraph of the previous Article shall be paid by:
- In the case of regular quality control, the marketing authorisation holder or the holder of marketing authorisation for parallel imported medicinal product;
- In the case of extraordinary quality control, the marketing authorisation holder for the medicinal products with such authorisation and the wholesaler for the medicinal products without such authorisation, if it turns out that the quality of a medicinal product is deficient. If it turns out that the quality of a medicinal product is adequate, the costs will be paid by the applicant for such extraordinary quality control;
- In the case of special quality control, the marketing authorisation holder for the medicinal products with such authorisation and the applicant stipulated under the third paragraph of Article 77 hereof for the medicinal products without such authorisation;
- In the case of quality controls of each first batch of medicinal products imported from third countries, prior to placing them on the market, the marketing authorisation holder;
- In the case of quality controls of medicinal products required in the framework of the procedure for obtaining marketing authorisation, the applicant specified in Article 22 hereof;
- In the case of quality controls of each first batch of medicinal product with marketing authorisation for parallel imported medicinal product, the holder of marketing authorisation for parallel imported medicinal product.
(3) The competent minister shall determine the substance and the deadlines of official quality controls of medicinal products, the sampling method and the price of service.
X. FEES
Article 94
(Fees)
(1) The applicant shall pay the fees for the procedures stipulated hereunder, unless otherwise stipulated hereby.
(2) The holders of marketing authorisations or the authorisations for parallel import of medicinal products and the holders of authorisation to perform activity, issued by the authority competent for medicinal products, shall also pay the annual fees for the monitoring of medicinal products on the market concerning individual medicinal products depending on the number of pharmaceutical forms.
(3) Legal entities and natural persons who submitted the applications for expert advice with the authority competent for medicinal products in accordance with Article 24 hereof, shall be obliged to pay the prescribed fees.
(4) The competent minister shall determine the amount of such fees.
XI. PRICES OF MEDICINAL PRODUCTS
Article 95
(Price formation)
The prices of medicinal products are not regulated and follow the market conditions unless in cases stipulated herein.

Article 96
(Price monitoring)
In the interest of protecting public health, the competent minister or the minister competent for veterinary medicine may determine certain medicinal products or groups of medicinal products the prices of which are determined by the authority competent for medicinal products.
Article 97
(Price determination)
(1) The prices of medicinal products for human use with marketing authorisation, authorisation for parallel import of medicinal products, as well as medicinal products without marketing authorisation but with entry or import authorisation which are included in the list stipulated by Article 15 hereof and are financed from public funds, are formed or determined according to the method specified by the competent minister.
(2) The prices of veterinary medicinal products with marketing authorisation or entry or import authorisation, the level of which could impact animal health care or harm the health of human beings, may in exceptional cases be formed or determined according to the method specified by the competent minister for veterinary medicine.
(3) The formation or determination of the prices of medicinal products from the previous paragraph may be prescribed at any level of medicinal product marketing.
(4) The competent minister may also request any data needed for determining the prices of medicinal products from the marketing authorisation holders and entry or import authorisation for medicinal products the prices of which are covered from public funds.
(5) The provisions of secondary legislation stated under the first and the second paragraphs hereunder, concerning the role of the competent authority, shall be implemented by the authority competent for medicinal products.
Article 98
(Application for the formation or determination of the prices of medicinal products)
(1) The application for the notification of the formed prices or price determination on the basis of secondary legislation stipulated under the previous article must be submitted by the marketing authorisation holders, the holders of authorisation for parallel imported medicinal products, and entry or import authorisation holders.
(2) The authority competent for medicinal products must resolve the complete application referred to in the previous paragraph within 90 days of receiving a complete application. In the case of excessive workload related to the number of applications, the authority may extend the deadline for resolving the application once, by a maximum of 30 days. If a decision is not issued within the abovementioned deadline(s), it shall be deemed that the applicant may market the medicinal product at the proposed price.
(3) If the Government adopts a measure of price regulation by determination of fixed prices of all medicinal products or individual groups of medicinal products, the marketing authorisation holder may address to the ministry competent for price regulation an application, together with the explanation, for examining the introduced price regulation measure. The ministry competent for price regulation shall be obliged to resolve the application within 90 days of receiving the complete application.
(4) Should the ministry competent for price regulation establish that the application for examining the introduced price regulation measure is not grounded, the marketing authorisation holder may submit an application to the government itself.
Article 99
(Obligation to use the applicable price)
The participants in the marketing of a medicinal product whose price is formed or determined on the basis of the secondary legislation referred to in Article 97 hereof must use the price of the medicinal product stipulated by such regulation in the marketing of such medicinal product.
Article 100
(Obligation to report other data)
Legal entities and natural persons authorised to market medicinal products or holding an appropriate evidence, specified in the third paragraph of Article 74 hereof must submit to the authority competent for medicinal products all data on the prices of medicinal products in a manner stipulated hereby, while data on veterinary medicinal products must also be submitted to the authority competent for veterinary medicine.
XII. SUPERVISION
Article 101
(Competences in supervision)
(1) Expert supervision in the field of medicinal products shall be carried out by the authority competent for medicinal products in the framework of pharmaceutical supervision. The tasks of pharmaceutical supervision shall be performed by the pharmaceutical supervisors.
(2) The official veterinarians supervise the implementation of the provisions of this Act and regulations issued on the basis of this Act relating to the use of medicinal products and the related traceability of veterinary medicinal products.
(3) The market inspectors supervise the implementation of the provisions of this Act and regulations issued on the basis of this Act relating to the prices of medicinal products.
Article 102
(Pharmaceutical supervisors)
(1) In order to be appointed a pharmaceutical supervisor, a person must satisfy the following criteria:
- Hold a university degree in pharmacy or other natural sciences with additional skills in good practices;
- Have at least 5 years of work experience;
- Have has passed a professional examination for a pharmaceutical supervisor.
(2) The supervisors shall be designated by the authority competent for medicinal products in accordance with the Civil Servants Act.
(3) When performing their tasks in accordance with their authorities, the supervisors shall be independent and shall perform such tasks in the scope and on the basis of the constitution and the law and always obliged to use their professional skills, educate further and participate in the training and examinations.
(4) The minister competent for health shall prescribe the contents and procedures of the expert examination for a pharmaceutical supervisor, as well as the contents and method of examining the skills and qualification of pharmaceutical supervisors.
Article 103
(Customs supervision)
The import of medicinal products shall be supervised by the customs authorities with expert support provided by the authority competent for medicinal products and the official veterinarians.
Article 104
(Competences of pharmaceutical supervisors)
(1) Pursuant to this Act, the pharmaceutical supervisors shall have the following competences and tasks:
- Conduct the violations procedure and impose sanctions for such violations;
- Order a legal entity or natural person to bring their operations in line with the requirements previously set out in this Act and the regulations arising hereof within a period of no more than six months since the receipt of the order calling for this measure;
- Ban the manufacture, testing or marketing of medicinal products on the grounds of non-conformity with prescribed conditions;
- Withhold marketing of a medicinal product or a particular batch which does not satisfy the prescribed conditions, is harmful if used in the prescribed way, has no therapeutic effect or its risk/benefit balance is not favourable if used in the prescribed way;
- Order destruction of a deficient medicinal product;
- Ban the entry or import of a medicinal product which has not been granted a marketing authorisation by the authority competent for medicinal products or has been transported against the manufacturer's instructions;
- Order the removal or destruction of the material used for illegal advertising of medicinal products;
- Prohibit the advertising of medicinal products that is not in compliance with the provisions of this Act;
- Order other measures necessary for the implementation of this Act and the regulations arising hereto.
(2) The pharmaceutical supervisor shall be independent in performing the supervision tasks, conducting and deciding in the administrative and violation procedure and shall identify in the performance of such tasks with the certificate issued by the director of the authority competent for medicinal products on the allocation to the post of pharmaceutical supervisor.
(3) In the scope of the tasks of supervising legal entities and natural persons, the pharmaceutical supervisor shall be entitled to do the following:
- Inspect the premises, facilities, installations, devices, equipment, fixtures, items, goods, substances, books of account, contracts, documents and other records as well as operations and documentation of government bodies, companies, institutions, organisations, communities and private individuals,
- Inspect the books of account, contracts, documents and other records as well as operations and documentation kept on the electronic media and demand hard copies thereof, which must be authentic in respect to the electronic form,
- Inspect the documents that prove the identity of persons,
- Obtain, free of charge, and use any personal or other data from official records and other databases related to the person concerned and needed for conducting pharmaceutical supervision,
- Take free samples of goods, materials and equipment and examine the samples taken,
- Take photographs or record on any other visual data carrier the data on persons, premises, facilities, installations, fixtures and other items stated under the first indent,
- Reproduce documents, audiovisual records and other evidence,
- Confiscate items, documents and samples to protect evidence,
- Do anything else in accordance with the aim of such pharmaceutical supervision.
(4) The pharmaceutical supervisor shall be entitled to enter the premises and facilities, and access the equipment and devices mentioned in the previous Article, unless otherwise stipulated hereby, without prior notification to the subject of inspection or its responsible person and regardless of the business hours.
(5) If, for no grounded reason, the person who is the subject of inspection refuses access to the premises or facilities in which the activity is performed, the pharmaceutical supervisor shall be entitled to enter the premises in spite of refused access. The costs of such entry and potential unavoidable damage shall be covered by the subject of inspection.
(6) An appeal against the measures stipulated under previous paragraphs, ordered by the pharmaceutical supervisor shall not prevent their implementation.
(7) Should a pharmaceutical supervisor establish any violations in the area of the use of veterinary medicinal products, the authority competent for veterinary medicine shall be informed thereof immediately.
(8) Should the pharmaceutical supervisor encounter any physical resistance during the pharmaceutical supervision, or if such resistance is expected, police assistance may be requested. The police shall provide assistance to pharmaceutical supervisors in accordance with the regulations on police.
Article 105
(Competence of market inspectors)
(1) If the persons marketing medicinal products failed to comply with the applicable prices, the market inspector shall be entitled to issue a decision and demand the following:
- That they use the applicable price,
- That they refund the undue amounts resulting from the difference in the price, with accrued interest.
(2) If the persons marketing the medicinal product failed to comply with the price stipulated on the basis of the secondary legislation stipulated under Article 97 hereof and charged too high prices to the payers, such persons shall be obliged to refund such unduly charged amounts to the payers within 15 days of the issue of a final decision by the market inspection authority, together with the accrued interest, without a specific request.
(3) Interest stipulated hereunder shall equal the default interest in economic transactions based on the law of obligations.
(4) The market inspection authority shall inform of its decision the authority competent for medicinal products or, in the case of veterinary medicinal products, also the minister or authority competent for veterinary medicine.
Article 106
(Competences of official veterinarians)
The official veterinary shall, in addition to rights and tasks set out in other regulations on inspection, also have the following competence to:
1. Conduct the violations procedure and impose sanctions for such violations.
2. Impose on the legal entity or natural person to harmonise the operations with the provisions of this Act and the regulations adopted on its basis.
Article 107
(Obligation to supply the market in accordance with the decision issued by a market inspector)
(1) If the persons marketing the medicinal product fail to start or stop selling a medicinal product on the basis of secondary legislation stipulated by Article 97 hereof upon their own initiative and if such action could seriously jeopardise the supply of medicinal products to the population, the market inspector may issue a decision specified in the first paragraph of the previous Article imposing on them to immediately start or continue selling such medicinal product, applying the prices stipulated on the basis of the secondary legislation defined under Article 97 hereof.
(2) In such decision, the market inspector shall lay down a deadline by which the persons marketing medicinal products must meet the obligation stipulated under the previous paragraph; nevertheless, such obligation may not last more than three months after the issue of the final decision by the market inspection authority.
Article 108
(Execution of decisions)
An appeal against the decision stipulated in Article 105 hereof shall not prevent its execution with the exception of refunding the unduly charged amounts in accordance with the second paragraph of the same Article.

XIII. PUBLIC AGENCY FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES
Article 109
(Foundation of the Public Agency)
(1) For the performance of tasks stipulated by this Act and the act regulating medical devices the Public Agency for medicinal products and medical devices of the Republic of Slovenia (hereinafter: the Public Agency) shall be founded as a public law entity.
(2) The founder of the Public Agency shall be the Republic of Slovenia. The rights of the founder shall be exercised by the Government.
(3) The ministry in charge of health shall exercise supervision over the work of the Public Agency.
(4) The provisions of the act regulating public agencies shall apply to the Public Agency, unless otherwise provided by this Act.
(5) The Public Agency for medicinal products and medical devices shall take over the tasks and competences Agency for medicinal products and medical devices of the Republic of Slovenia established within the Ministry of Health and the tasks of the official control laboratory stipulated under Article 91 hereof.
Article 110
(Tasks of the Public Agency)
The Public Agency shall perform the following tasks:
- Administrative, professional and development activities in the area of medicinal products and medical devices for human and veterinary use with the exception of defining doctrinal solutions in terms of safe use of medicinal products in veterinary medicine;
- Supervision in the area of medicinal products and medical devices for human and veterinary use with the exception of supervising the marketing of medicinal products used in veterinary medicine;
- The tasks of official control laboratory;
- Execution and adoption of decisions in national and European harmonised administrative and professional procedures of assessing quality, safety and efficiency of medicinal products and medical devices;
- The tasks of establishing, upgrading and modernising the regulatory information system and keeping official records on the basis of this Act;
- The tasks of pharmacovigilance and materiovigilance systems;
- The tasks of establishing internationally recognised quality system in the framework of good regulatory practice;
- The tasks in the area of determining, monitoring and analysing the prices of medicinal products and their impact on the functioning of the market;
- Expert support in the implementation of system orientations in the area of medicinal products and medical devices;
- The tasks that involve co-operation with other management, expert and scientific institutions.
Article 111
(Sources for the functioning of the Public Agency)
(1) The sources needed for the functioning of the Public Agency are:
- Fees;
- Income from the provision of official quality control services as stipulated under Article 93 hereof;
- Income from the provision of other expert services; and
- Funds from the budget of the Republic of Slovenia.
(2) The funds from the budget of the Republic of Slovenia shall only be granted for the provision of those services of the Public Agency the financing of which is not covered by the funds obtained from other sources on the basis of the Action Plan of the Public Agency, approved by the Government.
Article 112
(Bodies of the Public Agency)
(1) The bodies of the Public Agency shall be its Director and the Council of the Public Agency.
(2) The composition and the number of council members shall be determined by the founder in the Articles of Association.
(3) The Director and the council members may not be either employed by, or perform any form of work in, any organisation engaged in any form of for-profit activities activity in the area of medicinal products and medical devices, and may not have any function whatsoever in such organisations.
(4) Besides the reasons, stipulated by the act regulating public agencies, the Government shall dismiss the Director or a council member of the Public Agency also in the following cases:
- If the Director is declared unfit to conduct business or becomes incapable of performing the function for health reasons,
- If the grounds from the third paragraph of this Article arise,
- In the event of final judgement sentencing the Director to imprisonment for a criminal offence or for causing economic losses.
Article 113
(Reporting on the work of the Public Agency)
(1) At least once a year and no later than by 30 June, for the previous year, the Public Agency shall submit to the Government a report on its work and the situation in the field of medicinal products and medical devices.
(2) The Public Agency shall make the report from the first paragraph hereunder available to the public. Before the publication, the personal data and any data constituting a business secret shall be removed from the report.
Article 114
(Administrative decisions of the Public Agency)
(1) Pursuant to this Act, the Public Agency shall adopt administrative decisions in the administrative procedure at the first instance.
(2) The Public Agency shall perform all the tasks of the authority competent for medicinal products, stipulated hereby and any secondary legislation adopted on its basis or other applicable laws or regulations.
(3) Appeals against the decisions adopted by the Public Agency shall be decided on by the ministry competent for health, with the exception of the decisions falling within the competence of the market inspector, as stipulated herein, which shall be decided on by the ministry competent for the market.
(4) The Public Agency shall be the authority responsible for violations in the area of medicinal products and medical devices.
(5) A violations procedure shall be conducted and decided upon by an authorised official of the Public Agency, who fulfils the conditions laid down in the act regulating violations, and regulations adopted on the basis thereof.
XIV. PENALTY PROVISIONS
Article 115
(Sanctions for violations)
(1) A fine of between SIT 100,000 and SIT 500,000 shall be imposed on a legal entity or a natural person for committing a violation, as specified in Point 10 of Article 6 hereunder:
1. Act contrary to the fourth or the fifth paragraph of Article 82 hereof;
2. Act contrary to Article 100 hereof;
3. Act contrary to the second paragraph of Article 16, Point (d) of the second paragraph of Article 23, the fifth paragraph of Article 24 and Article 26 of the Regulation 726/2004/EC.
(2) A fine of between SIT 10,000 and SIT 50,000 shall be imposed on the responsible person of the legal entity or the natural person specified in the previous paragraph for committing a violation, as specified in Point 10 of Article 6 hereunder.
Article 116
(Sanctions for violations)
(1) A fine of between SIT 1,000,000 and SIT 25,000,000 shall be imposed on a legal entity or a natural person for committing a violation, as specified in Point 15 of Article 6 hereunder:
1. Act contrary to Article 44 hereof;
2. Perform the wholesale of medicinal products contrary to Article 73 hereof;
3. Perform the retail of medicinal products contrary to Article 79 hereof.
(2) A fine of between SIT 50,000 and SIT 500,000 shall be imposed on the responsible person of the legal entity or the natural person specified in the previous paragraph for committing a violation, as specified in Point 15 of Article 6 hereunder.
Article 117
(Sanctions for violations)
(1) A fine of between SIT 2,000,000 and SIT 30,000,000 shall be imposed on a legal entity or a natural person for committing a violation, as specified in Point 15 of Article 6 hereunder:
1. Act contrary to Articles 17 or 18 hereof;
2. Act contrary to Articles 11 and 12 hereof;
3. Act contrary to the second paragraph of Article 37 hereof;
4. Act contrary to the first paragraph of Article 46 hereof;
5. Act contrary to Article 50 hereof;
6. Act contrary to Article 54 hereof;
7. Act contrary to the second, third or fourth paragraph of Article 59 hereof;
8. Act contrary to Articles 66 or 67 hereof;
9. Act contrary to Article 72 hereof;
10. Act contrary to Article 74 hereof;
11. Act contrary to Article 76 hereof;
12. Act contrary to Articles 77 or 78 hereof;
13. Act contrary to Articles 79 and 81 hereof;
14. Act contrary to the first, second or third paragraph of Article 83 hereof;
15. Act contrary to Articles 86, 87 or 88 hereof;
16. Act contrary to Article 99 hereof.
(2) A fine of between SIT 100,000 and SIT 1,000,000 shall be imposed on the responsible person of the legal entity or the natural person specified in the previous paragraph for committing a violation, as specified in Point 15 of Article 6 hereunder.
Article 118
(Sanctions for violations)
(1) The Official Control Laboratory shall be punished by a fine of between SIT 1,000,000 and SIT 10,000,000 for acting contrary to Articles 93 and 76 of this Act.
(2) The responsible person of the Official Control Laboratory shall be punished by a fine of between SIT 50,000 and SIT 500,000 for an offence from the preceding paragraph.
Article 119
(Sanctions for violations)
A legal entity or a natural person specified in Point 15 of Article 6 hereunder who have been fined for committing violations listed in Articles 115, 116, 117 and 118 and who failed to pay the fine after the issue of a final decision, shall not be issued or extended an authorisation under the administrative procedure or a certificate regulated by this Act.
XV. TRANSITIONAL AND FINAL PROVISIONS
Article 120
(Deadline for the foundation of the Public Agency)
(1) The Government of the Republic of Slovenia shall found the Public Agency for medicinal products and medical devices stated in the third paragraph of Article 2 of this Act not later than one year after the enforcement of this Act.
(2) Until the foundation of the Public Agency for medicinal products and medical devices, the tasks of the authority competent for medicinal products shall be performed by the authority within the ministry competent for health.
(3) Until the foundation of the Public Agency for medicinal products and medical devices, the tasks of the official control laboratory shall be performed by the Institute of Pharmacy and Drug research - Ljubljana.
(4) The personnel, premises and equipment needed for starting the operations of the Public Agency for medicinal products and medical devices shall be provided by merging the resources of the Agency for medicinal products and medical devices of the Republic of Slovenia established within the Ministry of Health and the Institute of Pharmacy and Drug research - Ljubljana. Funds required for the starting the operations of the Public Agency shall be granted from the budget of the Republic of Slovenia.
(5) The Public Agency for medicinal products and medical devices shall take over all the employees who, at the day the Public Agency is founded, are employed by the Agency for medicinal products and medical devices of the Republic of Slovenia established within the Ministry of Health and the Institute of Pharmacy and Drug research – Ljubljana, including the equipment and assets, unfinished business, archives and records.
(6) The pharmaceutical inspectors working in the framework of the Agency for medicinal products and medical devices of the Republic of Slovenia established within the ministry competent for health shall, as of the day of the establishment of the Public Agency for medicinal products and medical devices, start performing the tasks of pharmaceutical supervisors in accordance with this Act.
Article 121
(Issue of implementing regulations)
(1) The deadline for the issue of implementing regulations hereunder shall be two years of the enforcement hereof, with the exception of regulations related to the implementation of the provisions stipulated by the Directive 2001/83/EC and the Directive 2001/82/EC which must be issued within one month of the enforcement hereof.
(2) Until the implementation of the implementing regulations issued on the basis of this Act, the following implementing regulations shall be used, issued on the basis of the Medicinal Products and Medicinal Devices Act (Official Gazette of the Republic of Slovenia nos. 101/99, 70/00, 7/02, 13/02 – ZKrmi, 67/02 and 47/04 – ZdZPZ), provided that they are not contrary to this Act or if not otherwise stipulated hereby:
- Rules on the Classification, Prescribing and Dispensing of Medicinal Products for Human Use (Official Gazette of the Republic of Slovenia nos. 59/03 and 114/03);
- Rules on the conditions to be met by analysts in analytical testing of medicinal products and procedure for the verification of these conditions (Official Gazette of the Republic of Slovenia, no. 43/00);
- Rules on pharmacological and toxicological testing of medicinal products (Official Gazette of the Republic of Slovenia, no. 44/00);
- Rules on clinical trial of medicinal products (Official Gazette of the Republic of Slovenia, no. 67/00),
- Rules on procedures relevant to the marketing authorization of medicinal products (Official Gazette of the RS, nos. 60/04, 77/04 and 103/05);
- Rules on the conditions and the procedure for obtaining a special authorisation for the import of medicinal products and devices (Official Gazette of the Republic of Slovenia, no. 72/00);
- Rules on analytical testing of medicinal products (Official Gazette of the Republic of Slovenia, no. 73/00);
- Rules concerning the requirements to be met by specialized shops for retail trade in medicinal products and on the procedure for ascertaining their compliance (Official Gazette of the Republic of Slovenia, nos. 73/00 and 54/03);
- Rules on labelling of medicinal products and on patient information leaflet (Official Gazette of the Republic of Slovenia, no. 82/00);
- Rules on the detailed conditions to be met by the manufacturer of medicinal products for human use and on the procedure for the verification of the manufacturer (Official Gazette of the Republic of Slovenia, no. 51/04);
- Rules on pharmacovigilance (Official Gazette of the Republic of Slovenia, no. 94/00);
- Rules on the methodology of pricing and quality control of medicinal products (Official Gazette of the Republic of Slovenia, no. 113/00);
- Rules on immunological medicinal products (Official Gazette of the Republic of Slovenia, no. 2/01);
- Rules on therapeutic substances of human origin (Official Gazette of the Republic of Slovenia, no. 2/01);
- Rules on radiopharmacological products (Official Gazette of the Republic of Slovenia, no. 7/01);
- Rules on wholesale pricing standards for medicinal products and the method of informing about wholesale prices of medicinal products (Official Gazette of the Republic of Slovenia, no. 69/05);
- Rules on the advertising of medicinal products and medical devices (Official Gazette of the Republic of Slovenia, no. 76/01);
- Rules on homeopathic products (Official Gazette of the Republic of Slovenia, no. 90/04);
- Rules on analytical testing of medicinal products for human use to perform state control of their quality (Official Gazette of the Republic of Slovenia, no. 74/04);
- Rules on detailed conditions of wholesale of medicinal products (Official Gazette of the Republic of Slovenia, no. 75/03);
- Rules classifying vitamin and mineral products for oral use that are in a pharmaceutical form as medicinal products (Official Gazette of the Republic of Slovenia, no. 83/03);
- Rules on costs (Official Gazette of the Republic of Slovenia, no. 74/05);
- Rules determining good manufacturing practice (Official Gazette of the Republic of Slovenia, no. 10/05);
- Rules on the principles of good laboratory practice (Official Gazette of the Republic of Slovenia, nos. 38/00 and 2/04);
- Rules on the assessment and procedures for compliance monitoring of the principles of good laboratory practice (Official Gazette of the Republic of Slovenia, no. 38/00);
- Rules on the classification of medical plants (Official Gazette of the Republic of Slovenia, no. 133/03);
- Rules on the specific part of the examination for pharmaceutical inspectors (Official Gazette of the Republic of Slovenia, no. 52/05);
- Order on the determination of medicinal products issued with or without prescription (Official Gazette of the Republic of Slovenia, no. 110/99);
- Order on permitted colouring agents (Official Gazette of the Republic of Slovenia, no. 72/00);
- Order appointing a legal person for pharmacovigilance and medical devices vigilance (Official Gazette of the Republic of Slovenia, no. 100/00);
- Order setting out a uniform national nomenclature of therapeutic agents and the system classifying medicinal drugs according to their anatomic-therapeutic-chemical classification (Official Gazette of the Republic of Slovenia, no. 72/00);
- Decision on the publication of the third supplement edition of the Anatomic-Therapeutic-Chemical Classification (ATC) of Medicinal Products 2003 (Official Gazette of the Republic of Slovenia, no. 114/03);
- List of indispensable medicinal products for human use (Official Gazette of the RS, nos. 16/04, 38/05 and 81/05);
- Rules determining national formulary addition to the European Pharmacopoeia (Official Gazette of the Republic of Slovenia, no. 86/05);
- Rules on the parallel import and parallel distribution of medicinal products (Official Gazette of the Republic of Slovenia, no. 73/05);
- Decision on the implementation of the European Pharmacopoeia 5th edition (Official Gazette of the Republic of Slovenia, no. 130/04);
- Decision on the implementation of the first, second and third supplement to the European Pharmacopoeia Fifth Edition (Official Gazette of the Republic of Slovenia, no. 31/05);
- Decision designating the official control laboratory for analytical testing of medicinal products for human use (Official Gazette of the Republic of Slovenia no. 51/04);
- Decision specifying the list of inter-exchangeable medicinal products (Official Gazette of the Republic of Slovenia, nos. 6/05 and 17/05);
- Rules on the authorisation for trade in veterinary medicinal products (Official Gazette of the Republic of Slovenia nos. 3/03 and 16/04);
- Rules on the conditions for the wholesale trade in the veterinary medicinal products (Official Gazette of the Republic of Slovenia nos. 75/00 and 1/04);
- Rules on the identification and use instructions of veterinary medicinal products (Official Gazette of the Republic of Slovenia nos. 86/00, 104/00, 86/01 and 4/02);
- Rules on the pharmacovigilance of veterinary medicinal products (Official Gazette of the Republic of Slovenia, no. 70/03);
- Rules on the retailers specialised in veterinary medicinal products (Official Gazette of the Republic of Slovenia no. 55/03);
- Rules determining good manufacturing practice for veterinary medicinal products (Official Gazette of the Republic of Slovenia, no. 75/05);
- Rules on the detailed conditions to be met by the manufacturer of medicinal products for veterinary use and on the procedure for the verification of the manufacturer (Official Gazette of the Republic of Slovenia, no. 28/04);
- Rules on electro-medicinal equipment for use in veterinary medicine (Official Gazette of the Republic of Slovenia, no. 28/04);
- Rules on conditions to be met by experts issuing expert opinions on veterinary medicinal products (Official Gazette of the Republic of Slovenia, no. 28/04);
- Rules on the nature, extent and method of the analytical, pharmacotoxicological and clinical testing of veterinary medicinal products (Official Gazette of the Republic of Slovenia, no. 28/04);
- Rules on the level of expenses for testing of medicinal products, granting of authorisation for the trade in veterinary medicinal products, and for expert supervision (Official Gazette of the Republic of Slovenia no. 28/04);
- Rules on the pharmacovigilance of veterinary medicinal products (Official Gazette of the Republic of Slovenia, no. 67/01);
- Rules on the committee for medicinal products to be used in veterinary medicine (Official Gazette of the Republic of Slovenia, no. 69/2000);
- Rules on the conditions to be met by analysts in analytical testing of veterinary medicinal products and procedure for the verification of these conditions (Official Gazette of the Republic of Slovenia, nos. 1/01 and 13/01);
- Rules on the classification, prescription and administering of veterinary medicinal products (Official Gazette of the Republic of Slovenia, no. 86/00);
- Rules on the exceptional use of medicinal products for the treatment of animals and on animal treatment records (Official Gazette of the Republic of Slovenia, no. 77/00);
- Rules banning the use of certain substances having a hormonal or thyrostatic action and beta-agonists in stock farming (Official Gazette of the Republic of Slovenia, no. 16/04).
(3) With the enforcement of this Act, the Resolution on determining good practices (Official Gazette of the Republic of Slovenia nos. 41/97) shall cease to be valid.
Article 122
(Procedures following the enforcement of this Act)
(1) All ongoing procedures until the implementation of this Act, or, in relation to which a claim or a legal remedy has been filed at the time of the entry into effect of this Act, shall be terminated according to the provisions of the Medicinal Products and Medicinal Devices Act (Official Gazette of the Republic of Slovenia nos. 101/99, 70/00, 7/02, 13/02 – ZKrmi, 67/02 and 47/04 – ZdZPZ), and the implementing regulations issued on the basis of this Act, unless the provisions of this Act are more favourable for the client.
(2) Notwithstanding the provisions of the previous paragraph, the authority competent for medicinal products may request from the applicant who filed the application prior to the enforcement of this Act and until the end of the procedure to submit additional or different documentation or comply with additional evidence in accordance herewith, should this be necessary for the protection of public health.
(3) The provisions on the periods of protection provided for in the first and the second paragraphs of Article 25 hereof shall not apply to reference medicinal products for which an application for authorisation has been submitted before the enforcement hereof.
(4) The provision of the fourth paragraph of Article 72 hereof shall apply for those medicinal products which obtained the marketing authorisation prior to the enforcement hereof no later than within five years after the enforcement hereof.
Article 123
(Updating of documentation)
By no later than 31 December 2007, the marketing authorisation holders who obtained such authorisations before the enforcement of the Medicinal Products and Medicinal Devices Act (Official Gazette of the Republic of Slovenia nos. 101/99, 70/00, 7/02, 13/02 – ZKrmi, 67/02 and 47/04 – ZdZPZ), and the regulations issued on the basis of this Act must submit the data and documentation referred to in Articles 23 and 25 hereof, if such data and documentation have not yet been submitted in the previous procedures related to the marketing authorisation.
Article 124
(Repealed provisions)
(1) On the day this Act enters into force, the Medicinal Products and Medicinal Devices Act (Official Gazette of the Republic of Slovenia nos. 101/99, 70/00, 7/02, 13/02 – ZKrmi, 67/02 and 47/04 – ZdZPZ), shall cease to be valid in the parts relating to medicinal products, namely:
- The entire: Articles 3, 5 to including 28, 113, 119 and 124,
- The parts relating to the prices of medicinal products and dietetic products used for the treatment of metabolic disorders: Article 126,
- In the part relating to medicinal products: Articles 1, 2, 4, 114, 117 and 118.
(2) On the day this Act enters into force, the title of the Medicinal Products and Medicinal Devices Act (Official Gazette of the Republic of Slovenia nos. 101/99, 70/00, 7/02, 13/02 – ZKrmi, 67/02 and 47/04 – ZdZPZ), shall be changed, namely, the words “medicinal products and” will be stricken out.
(3) The marketing authorisations for wholesaling medicinal products, relating to the imports of medicinal products, shall cease to be valid as of the day of enforcement of this Act.
Article 125
(Enforcement of the Act)
This Act shall enter into force on the fifteenth day after its publication in the Official Gazette of the Republic of Slovenia.

No. 520-02/99-3/17
Ljubljana, 7 March 2006
EPA 564-IV
Speaker of the National Assembly of the Republic of Slovenia France Cukjati, MD

1266. Medicinal Products Act (ZZdr-1), page 3217.
Pursuant to the second indent of the first paragraph of Article 107 and the first paragraph of Article 91 of the Constitution of the Republic of Slovenia, I hereby issue the following
D E C R E E
on the promulgation of the Medicinal Products Act (ZZdr-1)
I hereby promulgate the Medicinal Products Act (ZZdr-1), adopted by the National Assembly of the Republic of Slovenia at its session held on 7 March 2006.

No. 001-22-38/06
Ljubljana, 15 March 2006
Dr. Janez Drnovšek,
President of the Republic of Slovenia

MEDICINAL PRODUCTS ACT (ZZdr-1)
I. GENERAL PROVISIONS
Article 1
(Scope of application and competences)
(1) This Act defines medicinal products for use in human and veterinary medicine, stipulates the conditions and measures for assuring their quality, safety and efficacy, the conditions and procedures for their testing, manufacture, price, sales, official control and supervision with the aim of protecting public health, as well as defines the establishment and tasks of the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia.
(2) This Act defines the conditions and procedures for industrially manufactured medicinal products or medicinal products produced in a way that includes industrial procedures, including pre-mixes for the preparation of medicated feedingstuffs, medicinal substances used as input materials for certain substances that can be used as veterinary medicinal products that have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties.
(3) The purpose of this Act is to transpose into the legislation of the Republic of Slovenia the contents of the following directives and regulations and to regulate certain issues concerning the implementation of the following regulations:
– Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use Official Journal L 121, 01/05/2001 p. 34, with all the applicable amendments, hereinafter: the Directive 2001/20/EC);
– Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (Official Journal L 311, 28/11/2001 p. 1, with all the applicable amendments, hereinafter: the Directive 2001/82/EC);
– Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Official Journal L 311, 28/11/2001 p. 67, with all the applicable amendments, hereinafter: the Directive 2001/83/EC);
– Directive 2003/94/EC of the European Parliament and of the Council of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Official Journal L 262, 14 October 2003 p. 22, with all the applicable amendments, hereinafter: the Directive 2003/94/EC);
– Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Official Journal L 91, 9 April 2005 p. 13, with all the applicable amendments, hereinafter: the Directive 2005/28/EC);
– Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (Official Journal L 224, 18 August 1990 p. 1, with all the applicable amendments, hereinafter: the Regulation 2377/90/EEC);
– Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State (Official Journal L 159, 27 June 2003 p. 1, with all the applicable amendments, hereinafter: the Regulation 1084/2003/EC);
– Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Official Journal L 136, 30 April 2004 p. 1, with all the applicable amendments, hereinafter: the Regulation 726/2004/EC);
Article 2
(Authority)
(1) The competent minister (hereinafter: the minister) for medicinal products shall be the minister competent for health, unless otherwise stipulated herein.
(2) The implementing regulations for the area of veterinary medicinal products shall be issued by the competent minister in agreement with the minister competent for veterinary medicine.
(3) The authority competent for medicinal products covered by this Act shall be the Agency for Medicinal Products and Medical Devices.
(4) The authority competent for medicinal products shall decide in administrative matters in accordance with the act governing the general administrative procedure, unless otherwise determined by this Act.
(5) Unless otherwise determined by this Act, the authority competent for medicinal products must request that any incomplete applications be supplemented within 30 days of receiving such application and set a deadline in which the applicant (hereinafter: the applicant) must supplement such application.

Article 3
(Committees and specialists)
(1) The authority competent for medicinal products has established permanent and temporary committees and uses the services provided by individual specialists (hereinafter: the specialist). Within the scope of their operation the committees and individual specialists shall have a consultative role and shall be professionally independent and autonomous.
(2) There are permanent committees operating in the area of medicinal products, clinical trials and pharmacopoeia.
(3) Permanent committees are specialist bodies in various fields of activities. For the area of medicinal products for human use the composition and the members of such committees shall be determined by the competent minister and for the area of medicinal products for use in veterinary medicine, it shall be determined by the minister responsible for veterinary medicine, from among the experts (hereinafter: the expert) in the field of pharmacy, medicine, veterinary medicine, pharmacology and other fields.
(4) The permanent committees shall adopt their rules of procedure.
(5) Temporary committees and individual specialists shall be appointed by the authority competent for medicinal products, to discuss and issue opinions in various areas of expertise requiring special skills.
(6) Members of the committees and individual specialists must not be biased and must act in accordance with the applicable regulations. Because of the conflict of interest, they may not enable unjustified benefits or prioritise individual applicants and must comply with the provisions on data confidentiality.
Article 4
(Specialists in the bodies of the European Union)
(1) The specialists co-operating with the competent bodies of the European Union responsible for medicinal products for use in human medicine shall be determined by the competent minister upon the proposal of the body competent for medicinal products.
(2) The specialists co-operating with the competent bodies of the European Union responsible for medicinal products for use in veterinary medicine shall be determined by the minister responsible for veterinary medicine upon the proposal of the body competent for medicinal products.
Article 5
(Definition of medicinal product)
(1) Medicinal product shall mean any substance or combination of substances presented for treating or preventing disease in human beings or animals.
(2) Any substance or combination of substances which may be used on or administered to human beings or animals with a view to restoring, improving or modifying their physiological functions by pharmacological, immunological or metabolic means, or making a medical diagnosis, shall likewise be considered a medicinal product.
(3) Substances referred to in the first paragraph of this Article may be:
1. Of human origin - e.g. human blood, blood preparations, blood products;
2. Of animal origin - e.g. animals, parts of organs, animal secretions, toxins, extracts, blood products;
3. Of plant origin - e.g. plants, parts of plants, plant secretions, plant extracts;
4. Of microbial origin – e.g. whole microorganisms, their constituents;
5. Of chemical origin - e.g. elements, chemical substances appearing in nature in a certain form; chemical products obtained by chemical change or synthesis;
6. Developed by means of by biotechnological processes.
Article 6
(Definitions of other terms)
For the purposes of this Act, the terms shall have the following meanings:
1. Quality analysis of the medicinal product shall mean a qualitative analysis of all constituents, quantitative analysis of at least all active substances and all other tests, requisite for assessing quality of medicinal products in compliance with the marketing authorisation requirements.
2. Biological medicinal product shall mean a medicinal product that contains biological substances or substances obtained through a process including biological systems. A biological substance is a substance obtained from, or through the use of, a biological source, the quality of which is determined by means of a combination of physico-chemical and biological testing, together with the manufacturing process and supervision. These are for example medicinal products made by means of a biological or biotechnical process, including cell cultures and recombinant DNA technology, medicinal products derived from blood and plasma, immunological medicinal products and similar.
3. Centralised procedure shall mean the procedure for obtaining a marketing authorisation for the medicinal product in the European Union, as defined by the Regulation 726/2004/EC.
4. Decentralised procedure shall mean the procedure for obtaining a marketing authorisation for the medicinal product initiated simultaneously in the reference Member State and the EU Member States concerned. It is mandatory for those medicinal products not subjected to centralised procedure which have not yet obtained the marketing authorisation for the medicinal product in the European Union and which will be marketed in more than one EU Member State, as stipulated by the Directives 2001/83/EC and 2001/82/EC.
5. Good distribution practice shall mean a qualitative system governing the organisation, implementation and control of product storage in accordance with a defined regime prior to their further use or putting into circulation and transportation of medicinal products from the manufacturer to the end-user.
6. Good clinical practice in clinical trials in human medicine shall mean an international ethical and scientific system of quality control, planning, implementation, recording, controlling and reporting on clinical trials on humans, providing for the credibility of data acquired through trials and the protection of rights and the safety of trial subjects (hereinafter: the trial subjects) pursuant to the Declaration of Helsinki of the World Medical Association on biomedical testing on human subjects (1964) with all the amendments as well as pursuant to this Act and any regulations arising hereof.
7. Good clinical practice in clinical trials in veterinary medicine shall mean an international ethical and scientific system of quality control, planning, implementation, recording, controlling and reporting on clinical trials on target animals providing for the credibility of data acquired through trials and the safety of trial subjects pursuant to this Act, any regulations arising hereof and regulations on animal protection.
8. Good control laboratory practice shall mean the system of the analytical testing of a medicinal product, which can also be part of good manufacturing practice used for controlling the quality of products.
9. Good laboratory practice shall mean a qualitative system governing organisational processes and conditions of planning, implementing, controlling, recording and reporting on non-clinical medical and environmental studies.
10. Good manufacturing practice shall mean a system for ensuring quality, providing for the consistent manufacture and control of products by qualitative criteria and conformity assessing criteria with intended purpose as required by the documentation needed for obtaining the marketing authorisation or the specification of the product.
11. European Pharmacopoeia shall mean the pharmacopoeia as defined by the Council of Europe Convention on the elaboration of a European Pharmacopoeia (1964).
12. Pharmaceutical form shall mean a form incorporating the active substance(s) producing effects of medicinal products through technological processes, taking into account the physical and chemical characteristics of agent(s) and substances with ancillary action.
13. Pharmacopoeia shall mean a list of provisions regulating the manufacture of medicinal products, their identification, establishing their purity and testing the other quality parameters of the medicinal product and its component substances.
14. Pharmacovigilance shall mean system of identifying, collecting and evaluating the adverse reactions to medicinal products and other findings about the safety of a medicinal product and measures taken with the aim of managing and reducing the risks arising from medicinal products.
15. Natural person shall mean an individual sole proprietor (hereinafter: the individual) or any other natural person with permanent residence in the European Union, performing a gainful activity as his/her exclusive business activity, who complies with the relevant criteria of the Member State concerned.
16. Galenic product for human use shall mean a medicinal product prepared in a galenic laboratory of a pharmacy pursuant to existing pharmacopoeia and the principles of good practices intended for retail supply by the pharmacy in question.
17. Galenic product for use in veterinary medicine shall mean a medicinal product prepared in a galenic laboratory of a pharmacy pursuant to existing pharmacopoeia and the principles of good practices intended for retail supply.
18. Generic medicinal product shall mean a medicinal product with the same qualitative and quantitative composition, active substances and pharmaceutical form as the reference medicinal product whose bioequivalence with the reference medicinal product has been proved by suitable bioavailability studies. Various salts, esters, ethers, isomers, mixed isomers, complexes or active substance derivatives shall be treated as equal active substance unless they differ considerably in terms of safety or efficacy or both. In such case, the applicant must submit additional information on the safety or efficacy or both of various salts, esters, active substance derivatives in a medicinal product for which a marketing authorisation has already been obtained. Different oral forms with immediate release are considered to be the same pharmaceutical forms. Bioavailability studies need not be submitted if so stipulated by the relevant instructions prepared in accordance with the scientific and technical knowledge.
19. Homeopathic medicinal product shall mean a medicinal product prepared from substances called homeopathic stock by a homeopathic method described in the European Pharmacopoeia or the existing Pharmacopoeias of the EU Member States, if the European Pharmacopoeia does not contain such provisions. A homeopathic medicinal product may also contain a number of essential components.
20. The name given to a medicinal product may be either an invented name which shall not be liable to confusion with the common name or scientific name, together with a trade mark or the name of the marketing authorisation holder.
21. Medicinal product marketing authorisation holder shall mean a natural person or a legal entity with the registered office in the European Union, meeting the conditions specified in the Act.
22. Immunological medicinal product shall be those which consist of vaccines, toxins, serums and allergens, namely:
a) Vaccines, toxins and serums shall cover in particular the agents used to diagnose the state of immunity:
- agents used to produce active immunity,
- agents used to produce passive immunity,
- agents used to diagnose the state of immunity;
b) Allergen product shall mean any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent;
c) Immunological medicinal product shall mean a medicinal product for use in veterinary medicine administered to animals in order to produce active or passive immunity or to diagnose the state of immunity.
23. The issue of a medicinal product shall mean retail sales to the end user, accompanied with adequate expert support and consultancy.
24. The manufacturer of a medicinal product shall mean a legal entity or a natural person holding a manufacturing authorisation pursuant to this Act and any regulations arising hereof.
25. Off-label use shall mean the use of a veterinary medicinal product which is not consistent with the summary of the product characteristics but nevertheless allowed under this Act and the act regulating veterinary conformity criteria.
26. Exit of a medicinal product shall mean the wholesale from the Republic of Slovenia into other EU Member States.
27. Exports of a medicinal product shall mean the wholesale from the Republic of Slovenia into third countries.
28. The strength of a medicinal product shall mean the content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form.
29. Withdrawal period shall mean the period necessary between the last administration of the veterinary medicinal product to animals under normal conditions of use pursuant to this Act and any regulations arising hereof and the beginning of the production of foodstuffs from such animals, in order to ensure that such foodstuffs do not contain residues in quantities in excess of the maximum limits laid down in Regulation No. 2377/90/EEC.
30. Magistral preparation for human use shall mean a medicinal product prepared in a pharmacy on prescription for an individual patient.
31. Magistral preparation for use in veterinary medicine shall mean a medicinal product prepared in a pharmacy on veterinary prescription for an animal or a small group of animals.
32. National procedure for obtaining a marketing authorisation for the medicinal product in the Republic of Slovenia shall mean the procedure for obtaining a marketing authorisation for those medicinal products which are not subject to centralised procedure and for which marketing authorisation will only be issued for the sales in the Republic of Slovenia.
33. Maximum residue limit shall mean the maximum residue limit of medicinal products for use in veterinary medicine as stipulated by the Regulation No. 2377/90/EEC.
34. Package insert shall mean the information for the user attached in written form to the medicinal product, as a rule in the form of a leaflet.
35. Unexpected adverse reaction of a medicinal product shall mean adverse reaction, the nature, severity or outcome of which is not consistent with the summary of the product characteristics.
36. Unexpected adverse reaction in clinical trials shall mean adverse reaction, the nature, severity or outcome of which is not consistent with the applicable product information (e.g. investigator's brochure or summary of product characteristics).
37. Adverse reaction in clinical trials shall mean any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
38. Adverse reaction to a medicinal product shall mean a reaction which is noxious and unintended and which occurs at doses normally used in humans or animals for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.
39. Human adverse reaction caused by veterinary medicinal products shall mean a reaction which is noxious and unintended and which occurs in humans unintentionally exposed to a veterinary medicinal product.
40. Adverse reaction in clinical trials shall mean all untoward and unintended responses to an investigational medicinal product related to any dose administered.
41. Public service obligation shall mean the obligation placed on wholesalers in medicinal products and holders of marketing authorisation to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.
42. Labelling of medicinal product shall mean information on the immediate or outer packaging.
43. Parallel distribution shall mean the entry of a medicinal product for which marketing authorisation was obtained in accordance with the centralised procedure from one Member State of the European Union or the European Economic Area (hereinafter: the EEA) to another, if performed by a wholesaler who is not in a business relationship for the marketing of such medicinal product with the holder of marketing authorisation, in accordance with the applicable regulations.
44. Parallel import shall mean the entry of a medicinal product for which marketing authorisation was obtained in the exporting country that is similar enough to the medicinal product for which marketing authorisation was obtained in the Republic of Slovenia according to the national procedure, the mutual recognition procedure or the decentralised procedure and is entered from one Member State of the European Union or the European Economic Area (hereinafter: the EEA) to another on the basis of the marketing authorisation for parallel imported medicinal product issued by a body competent for medicinal products if parallel import is performed by a wholesaler who is not in a business relationship for the marketing of such medicinal product with the holder of marketing authorisation.
45. Periodic safety update report shall be a periodic report submitted in predetermined intervals or upon the request of the body competent for medicinal products by the marketing authorisation holder, which must include all the prescribed data on the safety of the medicinal product and the estimate on the relationship between the risks and the benefits.
46. Substance with ancillary action shall mean substance having physical characteristics which can support the action of a medicinal product and improve its tolerability.
47. Mutual recognition procedure shall mean the procedure for obtaining marketing authorisation for the medicinal product initiated after the approval in the reference Member State also in other EU Member States concerned and is mandatory for those medicinal products not subjected to centralised or decentralised procedure for the issue of marketing authorisation which will be marketed in more than one EU Member State, as stipulated by the Directives 2001/83/EC and 2001/82/EC.
48. Pre-mixes for medicated feedingstuffs shall mean any medicinal product prepared in advance for use in veterinary medicine, intended for the subsequent manufacture of medicated feedingstuffs.
49. Representative of the marketing authorisation holder shall mean a legal entity or natural person acting on behalf of the marketing authorisation holder as its representative in the Republic of Slovenia.
50. Manufacturer of a medicinal product shall mean a legal entity or natural person responsible for the development, manufacture, quality control, packaging and labelling of medicinal products as well as their safety and efficacy irrespective of whether medicinal products were manufactured by themselves or on their behalf by a third party.
51. Wholesale distribution of medicinal products shall mean the activity of purchasing, storing, selling, entering, exiting, importing or exporting of medicinal products with the exception of issuing medicinal products to individual natural persons or legal entities for their personal use or the use in the performance of medical activity.
52. Radiopharmaceuticals are radiopharmaceuticals, radionuclide precursors, radionuclide generators and radionuclide kits, namely:
a) radiopharmaceutical shall mean a medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) intended for medicinal use,
b) radionuclide generator shall mean any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be obtained by elution or by any other method and used in a radiopharmaceutical,
c) radionuclide precursor shall mean any radionuclide produced for the labelling of another substance prior to administration to a patient,
č) radionuclide kit shall mean any preparation to be reconsitituted or combined with radionuclides (radionuclide precursors) in the final radiopharmaceutical, usually prior to its administration.
53. Risk/benefit balance shall mean a positive assessment of the therapeutic efficacy of a medicinal product in comparison with the risk, as defined in Points 64 and 65 hereunder.
54. Reference Member State shall mean the Member State which compiles, in the mutual recognition procedure or the decentralised procedure, the report on the assessment of the medicinal product on the basis of which the EU Member States concerned shall decide on the acceptability of the risk/benefit balance and/or the assessment of quality, safety and efficacy of a medicinal product in accordance with the Directives 2001/83/EC and 2001/82/EC.
55. Reference medicinal product shall mean a medicinal product for which marketing authorisation has been issued on the basis of Article 23 hereof and to whose documentation other applicants pursuant to this Act and any regulations arising hereof shall refer.
56. Serious adverse reaction or serious adverse reaction in clinical trials shall mean any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.
57. Serious adverse reaction of a medicinal product for use in human medicine shall mean any adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.
58. Serious adverse reaction of a medicinal product for use in veterinary medicine shall mean any adverse reaction which is fatal, life-threatening, incapacitating and constant, a prolonged occurrence of signs and symptoms of disease in a treated animal, or is a congenital anomaly/birth defect.
59. Risk medicinal products shall mean immunological medicinal products and medicinal products derived from blood and plasma.
60. Specialised shop selling over-the-counter medicinal products shall mean a retail outlet selling those medicinal products which the authority competent for medicinal products allows to be dispensed without prescription in pharmacies and specialised shops.
61. Common name of a medicinal product shall mean the international non-proprietary name recommended by the World Health Organization, or, if one does not exist, the usual common name.
62. Sponsor of a clinical trial shall mean a legal entity, natural person or individual who takes responsibility for the initiation, management and/or financing of a clinical trial.
63. Immediate packaging shall mean a container or other form of packaging immediately in contact with the medicinal product.
64. Study of the safety of medicinal product after obtaining the marketing authorisation for a medicinal product used in human medicine shall mean a pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying or quantifying a safety hazard relating to an authorised medicinal product.
65. Study of the safety of medicinal product after obtaining the marketing authorisation for a medicinal product used in veterinary medicine shall mean a pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying or investigating a safety hazard relating to an authorised medicinal product for use in veterinary medicine.
66. Traditional herbal medicinal product shall mean a herbal medicinal product whose properties can be recognised on the basis of its traditional use and which meets the conditions stipulated by this Act.
67. Third countries shall mean the Non-Member States of the European Union or the EEA Agreement.
68. Risk related to the use of medicinal product shall mean:
a) Any risk of the occurrence of environmentally harmful adverse reactions,
b) Any risk to the health of a patient or animal or public health, related to the quality, safety or efficacy of a medicinal product.
69. Active ingredient shall mean a substance which can support the action of a medicinal product.
70. Official control laboratory shall mean a legal entity or a natural person holding the authorisation of the authority competent for medicinal products for analytical testing of medicinal products appointed by the competent minister for verifying whether the official quality of medicinal products, which is a member of the European network of official control laboratories or which annually participates in the intra-laboratory verification organised by the European Directorate for the Quality of Medicines and the results achieved are in compliance with the organiser’s requirements;
71. Import of a medicinal product shall mean the wholesale from third countries into the Republic of Slovenia.
72. Wholesaler in medicinal products shall mean a legal entity or a natural person wholesaling medicinal products on the basis of the authorisation issued by the authority competent for medicinal products with the aim of generating profit or not.
73. Entry of a medicinal product shall mean the wholesale from other EU Member States into the Republic of Slovenia.
74. Member State concerned shall mean the Member State which shall decide, in the mutual recognition procedure or the decentralised procedure, on the acceptability of the risk/benefit balance and/or the assessment of quality, safety and efficacy of a medicinal product on the basis of the report on the assessment of the medicinal product compiled by a reference EU Member States in accordance with the Directives 2001/83/EC and 2001/82/EC.
75. Medicinal products derived from blood or plasma shall mean those medicinal products manufactured by means of industrial procedures by specialised legal entities or natural persons from blood components obtained in accordance with the provisions of the Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L no. 33 of 8.2.2002, p. 30) which contain above all albumin, coagulating factors and immunoglobulins of human origin, taking into account the self-sufficiency principle.
76. Medicated feedingstuffs shall mean any mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a medicinal product.
77. Herbal medicinal product shall mean any medicinal product which cannot contain one or more herbal substances, one or more herbal preparations or one or more herbal substances in combination with one or more herbal preparations as active ingredients.
78. Medical or veterinary prescription shall mean a document issued in accordance with the applicable regulations by an expert qualified and authorised to prescribe medicinal products.
79. Abuse of medicinal product shall mean persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effects.
80. Outer packaging shall mean the packaging into which is placed the immediate packaging.
Article 7
(Relationship between medicinal and other products)
(1) If, by definition and taking into account all its characteristics, a medicinal product can simultaneously be classified as medicinal product and as product subject to other provisions, the provisions of this Act shall apply in the case of doubt.
(2) The classification referred to in the previous paragraph shall be decided in an administrative procedure on the basis of a special declaratory procedure by the authority competent for medicinal products.
(3) The costs of establishing the adequacy of the proposed definition shall be borne by the applicant.
Article 8
(Prohibition of inappropriate presentation of products)
It is prohibited to place on the market any products with an alleged healing properties or disease prevention properties for use in human or veterinary medicine which pursuant to this Act, are not considered a medicinal product.
Article 9
(Equal manufacturing requirements)
The provisions of this Act on manufacturing and import shall also apply to medicinal products intended for placement on the market outside the territory of the Republic of Slovenia and for intermediate products not intended for further processing.
Article 10
(Exceptions to the application of this Act)
The provisions of this Act shall not apply to the following:
1. Magistral preparations regulated by the provisions on pharmaceutical activity;
2. Galenic products regulated by the provisions on pharmaceutical activity;
3. Intermediate products intended for further processing by manufacturing authorisation holders, if intermediate products are not regulated as medicinal products;
4. Radioactive isotopes in the form of sealed sources regulated by the provisions on protection against ionising radiation and nuclear safety;
5. Blood, plasma or blood cells regulated by the provisions on blood supply, except for industrially processed plasma;
6. Medicated feedingstuffs regulated by the provisions on feedingstuffs;
7. Inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality regulated by the provisions on veterinary medicine;
8. Feed additives stipulated by the provisions on feedingstuffs.
Article 11
(Classification of medicinal products on the basis of prescribing practices)
(1) In terms of prescribing practices, medicinal products shall be classified into:
- medicinal products for which medical or veterinary prescription is required,
- medicinal products for which medical or veterinary prescription is not required,
(2) The competent minister shall determine the definition, classification and the manner of prescribing medicinal products.
Article 12
(Protection of data upon the modification of classification)
If a modification of classification is approved for a medicinal product for which medical or veterinary prescription is required among medicinal products for which no medical or veterinary prescription is required on the basis of significant non-clinical pharmacotoxicological tests or clinical trials, the authority competent for medicinal products shall not be allowed to refer to the results of such tests or clinical trials when studying the application of another applicant or marketing authorisation holder for a modification in the classification of the same active ingredient in the period of one year after the first approval of modification.
Article 13
(Traditional herbal medicinal products)
(1) Traditional herbal medicinal products must meet the following requirements:
1. They may have therapeutic indications, suitable for traditional herbal medicinal products only, which, by virtue of their composition and purpose, are intended for self-medication;
2. They can only be administered in accordance with the prescribed strength and dosage;
3. They are intended for oral or external use or for inhalation;
4. The period of its traditional use has expired;
5. The data on the traditional use of medicinal product must be sufficient; in particular, it must be proved that the product is not harmful if used as foreseen and that the pharmacological effects or efficacy of the medicinal product are probable on the basis of long-term use and experience.
(2) Traditional herbal medicinal products ma also contain vitamins and minerals provided that there exists documented evidence on their safety and that such vitamins and minerals support the activity of herbal substances in terms of the stated therapeutic indications.
(3) If the authority competent for medicinal products establishes that the traditional herbal medicinal product meets the criteria for obtaining the marketing authorisation or registration for the homeopathic medicinal product, the provisions applicable to traditional herbal medicinal product shall not apply.
Article 14
(Homeopathic medicinal products)
(1) Marketing authorisation for homeopathic medicinal products must be obtained pursuant to Article 23 hereof.
(2) Notwithstanding the provision of the previous paragraph, a simplified procedure for obtaining the marketing authorisation (registration procedure) shall be applied to homeopathic medicinal products for external or oral use, provided that they meet the following requirements:
1. The outer packaging and the instructions for use do not indicate any healing effect or therapeutic indication or information relating to them;
2. They have a sufficient degree of dilution to guarantee the safety of the product, as stipulated by the regulations.
(3) All the provisions of this Act shall apply to all homeopathic medicinal products, unless otherwise stipulated herein.
(4) A more specific determination, labelling, advertising and conditions for the issue of marketing authorisation and the simplified registration procedure for homeopathic medicinal products shall be determined by the competent minister.
Article 15
(List of urgently needed medicinal products)
(1) The competent minister may prescribe a list of urgently needed medicinal products for use in human medicine.
(2) The minister competent for veterinary medicine may prescribe a list of urgently needed medicinal products for use in veterinary medicine.
(3) Urgently needed medicinal products are those which are necessary in the provision of human and/or animal health care on the basis of the latest findings of biomedical science and profession and the systemic definitions in the framework of the national health priorities.
Article 16
(Interchangeable medicinal products)
(1) Interchangeable medicinal products are those products that the body competent for medicinal products defines and publishes as suitable for interchanging, taking into account the fact that the probability of the occurrence of clinically significant differences in the efficiency and safety of such medicinal products are adequately low or negligible; such decision must be supported by:
- Identification of common or comparable characteristics of medicinal products or groups of medicinal products pursuant to this Act or the regulations adopted on its basis;
- Consideration of provisions stipulated by marketing authorisation;
- Incorporation of the latest findings and discoveries of biomedical science and profession;
- Opinion of the Medicinal Products Committee;
- Data on pharmacovigilance.
(2) Medicinal products referred to in the previous paragraph can only be interchanged by persons authorised for prescribing medicinal products or persons authorised for issuing medicinal products, as stipulated by the relevant provisions.
(3) The competent minister shall prescribe more detailed requirements and procedures for establishing interchangeability of medicinal products.
Article 17
(Marketed medicinal product)
(1) A medicinal product can be marketed:
- Provided that it has obtained marketing authorisation in accordance with this Act or the centralised procedures stipulated by the provisions of the European Union;
- Provided that it is authorised for the needs of an individual patient by the authority competent for medicinal products upon the request of the personal physician, clinic or institute, at their personal responsibility;
- Provided that the authority competent for medicinal products temporarily allows the marketing of a medicinal product without marketing authorisation in exceptional situations (infections, poisoning, radiation and similar) or for any other reasons in the interest of public health protection;
- Provided that the authority competent for medicinal products, on the proposal of the authority competent for veterinary medicine temporarily allows the marketing of an immunological veterinary medicinal product without marketing authorisation, if no appropriate medicinal product is available, in which case the body competent for veterinary medicine informs the European Commission in advance of the conditions of use; or
- Provided that it is included in the list of urgently needed medicinal products, stipulated in Article 15 hereof, without marketing authorisation.
(2) Notwithstanding the provision of the first indent of the previous paragraph, medicinal products without marketing authorisation can be used for research and development purposes as well as those with appropriate authorisation for clinical trials or further processing.
(3) Notwithstanding the provision of the first indent of the previous paragraph hereunder, veterinary medicinal products without marketing authorisation can be used for veterinary emergencies (for example prevention of foot-and-mouth disease) if their use in such conditions is approved by the authority competent for veterinary medicine and the competent institution of the European Union.
Article 18
(Off-label use of veterinary medicinal products)
(1) If no suitable veterinary medicinal product with adequate marketing authorisation for the Republic of Slovenia is available to treat the disease state of certain animal species, a veterinary responsible for the treatment of animals can, in order to prevent unacceptable suffering of animals, exceptionally approve medicinal products without marketing authorisation for the use in such species or to treat the disease state concerned.
(2) The competent minister shall determine in greater detail the conditions for off-label use.
Article 19
(Responsibility)
(1) The marketing authorisation holder shall be responsible for the placing of medicinal product on the market.
(2) The manufacturer of the medicinal product shall be responsible for the damage caused by inappropriate quality of the medicinal product or the consequences of the use of such medicinal product even if it is proved that it would not be possible for the global science to discover the defect or the consequences of use, in view of the current level of technological development in the moment the medical product was placed on the market.
(3) Marketing authorisation holder, manufacturer and health professionals shall not be responsible for the consequences of treatment arising from the use of medicinal product which is not in accordance with the issued marketing authorisation or the use of medicinal product without a marketing authorisation, if such use was recommended or requested by the authority competent for medicinal products in the event of the spread of pathogenic substances, toxins, chemical substances or nuclear radiation which could be harmful to the health of humans or animals or damage the environment.
Article 20
(Pharmacopoeia)
(1) Medicinal products marketed in the Republic of Slovenia must be manufactured and controlled according to the requirements of the European Pharmacopoeia and the Slovene national supplement thereof as prescribed by the competent minister.
Should the European Pharmacopoeia and the Slovene national supplement thereof not prescribe methods of manufacture and requirements concerning quality of medicinal products, such medicinal products may be manufactured and controlled according to methods and requirements of pharmacopoeias of other EU Member States. Should the pharmacopoeias of other EU Member States not prescribe methods of manufacture and requirements concerning quality, medicinal products may subjected to methods and requirements of the pharmacopoeias of third countries or to the methods proposed by the manufacturer.
II. MARKETING AUTHORISATION
Article 21
(Marketing authorisation)
(1) A medicinal product can only be marketed on the basis of marketing authorisation.
(2) Notwithstanding the provisions of the previous paragraph, the marketing authorisation shall not be required for medicinal products stated in Article 10 of this Act and for the following:
1. Medicinal products subject to clinical trials;
2. Medicinal products intended for treatment as a continuation of a treatment started abroad;
3. Intermediate products which will be processed further;
4. Medicinal products to be used in research and development;
5. Medicinal products with marketing authorisation for parallel imported medicinal products.
Article 22
(Marketing authorisation holder)
(1) The procedure for the issue of marketing authorisation shall begin with the submission of an application by a natural person or legal entity with registered office in the European Union. This can be either the manufacturer of the medicinal product or a natural person or a legal entity that has concluded a written agreement with the manufacturer and meets the requirements stipulated hereby.
(2) The marketing authorisation holder shall have established a pharmacovigilance system and appointed an appropriately qualified person responsible for pharmacovigilance, who must be available at all times.
(3) Such appropriately qualified person responsible for pharmacovigilance must have a permanent residence on the territory of the European Union and hold a university degree in pharmacy or human medicine specialised in human medicinal products or hold a university degree in pharmacy or veterinary medicine specialised in veterinary medicinal products. If such person does not have appropriate qualification, then he or she must have the possibility to seek professional assistance of a person holding a university degree in pharmacy or human medicine specialised in human medicinal products or holding a university degree in pharmacy or veterinary medicine specialised in veterinary medicinal products at all times.
(4) If the marketing authorisation holder does not have a registered office in the Republic of Slovenia, it can appoint, besides the responsible person, also a contact person for pharmacovigilance on the territory of the Republic of Slovenia.
Article 23
(Application for obtaining marketing authorisation)
(1) The application for obtaining marketing authorisation shall comprise documents, samples and reference standards, if necessary and if required by the authority competent for medicinal products.
(2) The documents pursuant to the preceding paragraph shall comprise:
1. General part, including data on the manufacturer, manufacturing site and the applicant for marketing authorisation, data on medicinal product, data on previously issued or rejected marketing authorisations, the summary of product characteristics, package insert, draft packaging, data on the status of orphan medicinal products, if obtained, expert reports and summaries, estimates of risk/benefit balance, environmental impact assessment and other data necessary for public health protection, especially in the case of risk medicinal products.
2. Pharmaceutical-chemical and biological part including data on quality and quantity of the composition, description of the method of preparation, quality control of starting material, quality control carried out at intermediate stages of the manufacturing process, quality control of the finished product, stability tests and other data necessary for public health protection.
3. Non-clinical pharmacotoxicological part, including data on the pharmacodynamic and pharmacokinetic properties of a medicinal product, its toxicity and effect on the reproductive function, data on embryo-foetal toxicity, mutagenic potential and carcinogenic potential, data on local tolerance, excretion and other data necessary for public health protection. The pharmacotoxicological part of the documentation related to veterinary medicinal product should also include data on residues and proposed withdrawal periods.
4. Clinical part of documentation including general data on trials, how they have been carried out and ensuing results, clinical and pharmacological data, data on bioavailability/bioequivalence (if required), clinical safety and efficacy, documentation on exceptional circumstances in trials (if required) and data on experience with the product gained in other countries which have authorised marketing and other data necessary for public health protection.
Article 24
(Expert advice)
Before the beginning of the procedure for obtaining marketing authorisation, the authority competent for medicinal products shall provide orientations and advice, if requested by the client, concerning the compilation and the expert contents of the application.

Article 25
(Generic medicinal products)
(1) Notwithstanding the provisions of Article 23 of this Act, the applicant need not submit the results of non-clinical pharmacotoxicological tests or clinical trials of the veterinary medicinal products nor the results of residue tests, if proven that the subject of the procedure is a generic medicinal product whose reference medicinal product has obtained marketing authorisation in the Republic of Slovenia or the European Union at least eight years earlier.
(2) A generic medicinal product referred to in the previous paragraph may not be marketed for ten years after obtaining the marketing authorisation for the reference medicinal product.
(3) If the reference medicinal product referred to in the first paragraph hereunder did not obtain marketing authorisation in the Republic of Slovenia, the applicant shall state in the application for obtaining marketing authorisation the EU Member State in which such authorisation had been obtained.
(4) Within 30 days of receiving the complete application the authority competent for medicinal products shall ask the competent authority of the selected Member State of the European Union to issue the certificate of issued marketing authorisation for the reference medicinal product concerned and the qualitative and quantitative particulars of the composition in terms of the active substances and constituents of the excipient of the reference medicinal product and, if necessary, any other relevant documents.
(5) In line with the EU regulations, a Member State that issued the marketing authorisation for the reference medicinal product shall send the certificate and data referred to in the previous paragraph within one month of receiving the request.
Article 26
(Data protection)
(1) The ten-year period referred to in the second paragraph of the previous Article shall be extended to a maximum of 11 years if, during the first eight years of the ten-year period referred to in the second paragraph of the previous Article, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which are expected to bring a significant clinical benefit in comparison with existing therapies.
(2) For veterinary medicinal products the ten-year period referred to in the second paragraph of the previous Article shall be extended to 13 years in respect of medicinal products for fish, bees and other animal species pursuant to this Act and any regulations arising hereof.
Article 27
(Additional requirements)
If a medicinal product does not correspond to the definition of a generic medicinal product or if bioequivalence cannot be proven by means of suitable bioavailability studies or changes in the active substances, indications, strength, pharmaceutical form or method administration in respect to the reference medicinal product, it shall be necessary to submit the results of non-clinical pharmacotoxicological tests or clinical trials of the veterinary medicinal products as well as the results of the tests of safety and residues of the medicinal product.

Article 28
(Biological medicinal products)
If a biological medicinal product similar to the reference medicinal product does not correspond to the definition of a generic medicinal product because of the differences related to starting materials or manufacturing procedure compared to the reference medicinal product, the application for marketing authorisation shall be accompanied by the results of adequate non-clinical pharmacotoxicological tests or clinical trials relating to the stated differences. The type and scope of additionally required data shall be in compliance with the requirements of this Act and any regulations arising hereof.
Article 29
(Well established use)
Notwithstanding the provisions of Article 23 of this Act, the applicant need not submit own data on non-clinical pharmacotoxicological tests or clinical trials of the veterinary medicinal products nor the results of residue tests, if proven that the active substance of the veterinary medicinal product have a well-established medicinal or veterinary use, with recognized efficacy and an acceptable level of safety, and has been used on the territory of the European Union in appropriate scope for at least ten years and if enough literature on the use of active substance is available. In such case, adequate data from the available literature must be submitted instead of own data.
Article 30
(Well established use and data protection)
(1) If the components of the medicinal product have a well-established medicinal use, with recognized efficacy and an acceptable level of safety and such medicinal product has obtained marketing authorisation for a new indication for which significant non-clinical pharmacotoxicological tests or clinical trials have been submitted, other applicants shall not be allowed to refer to this part of documentation for a non-cumulative period of up to one year.
(2) If the applicant has used scientific literature for obtaining marketing authorisation for a veterinary medicinal product for use in food producing animals and has submitted, in respect of the same medicinal product and for the needs of obtaining authorisation for another species of food producing animals, new studies on medicinal product residues in accordance with the Regulation 2377/90/EEC together with further clinical trials, then other applicants may not refer to the data of such studies or the results of tests in accordance with the provisions of Article 25 hereof for the period of three years following the issue of marketing authorisation for the purpose of which they have been carried out.
Article 31
(Data protection for veterinary medicinal products)
(1) In veterinary medicinal products foreseen for one or more species of food producing animals which contain new active substances and have not been allowed in the European Union before 30 April 2004, the ten-year period stipulated by the second paragraph of Article 25 hereof shall be extended by one year in each case of extension to the marketing authorisation for another species of food producing animals, provided that such extension to the marketing authorisation is obtained within five days of issuing the initial marketing authorisation.
(2) The period stipulated by the second paragraph of Article 25 hereof, together with any extensions under the previous paragraph may not be longer than 13 years which also applies to the extension to marketing authorisation related to four or more species of food producing animals.
(3) The extension of the ten-year period to 11, 12 or 13 years for a veterinary medicinal product, foreseen for food producing animals, shall only be granted if the marketing authorisation holder has previously submitted the application for determination of maximum residue limit for those species covered by the marketing authorisation.
Article 32
(Generic medicinal products and patent rights)
The necessary studies conducted with the aim of fulfilling the requirements of Articles 25, 27, 28 and 29 hereof and meeting other requirements related to the obtaining of marketing authorisation shall not represent a violation of patent rights or the rights arising from additional safety certificate for a medicinal product.
Article 33
(Combinations of active substances)
If the application concerns new medicinal products containing active substances present in the medicinal products for which marketing authorisations have already been issued, however, not hitherto used in the proposed combination for therapeutic purposes, the results of toxicological and pharmacological tests and of clinical trials relating to that combination must be provided, but it shall not be necessary to provide references relating to each individual substance. The application for veterinary medicinal products must also contain the results of safety and residue tests, if necessary or required by the authority competent for medicinal products.
Article 34
(Approved use of documentation)
Marketing authorisation holder may authorise the use of data from the pharmaceutical, chemical, biological, non-clinical pharmacological-toxicological and clinical part of documentation for veterinary medicinal products as well as data from the documentation on safety and residue tests which is a constituent part of the application on the basis of which the marketing authorisation has been obtained, for compiling or processing the subsequent applications for other medicinal products with the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.
Article 35
(Exceptional circumstances)
Notwithstanding the provisions of Article 23 of this Act and in exceptional circumstances related to immunological medicinal products for the use in veterinary medicine, the applicant need not submit the results of certain on-the-field tests carried out in the target species if such tests cannot be carried out because of well-grounded reasons.
Article 36
(Registration of a traditional medicinal product)
(1) Simplified procedure for obtaining the marketing authorisation shall be applied to traditional herbal medicinal products (traditional medicinal product registration procedure), in which the applicant shall enclose with the application a general part and the pharmaceutical-chemical and biological documentation in accordance with Points 1 and 2 of the second paragraph of Article 23 hereof. Instead of data referred to in Points 3 and 4 of the second paragraph of Article 23 of this Act, the following shall be submitted:
1. Bibliographic or expert evidence that the medicinal product concerned, or other appropriate medicinal product had been used for medical purposes for at least 30 years prior to the date of application, of which at least 15 years in the European Union. If a medicinal product had been used in the European Union for less than 15 years and nevertheless meets the conditions prescribed for traditional herbal medicinal products, the authority competent for medicinal products shall submit evidence of long-term use of such medicinal product or another adequate medicinal product to the European Medicines Agency; and
2. Bibliographic overview of data on the safety, together with the expert report and, if requested by the authority competent for medicinal products, any other data needed for the assessment of safety of the medicinal product.
(2) The competent minister shall prescribe the necessary evidence of medical use during the 30-year period, the requirements for other appropriate medicinal product and the form and contents of the required documentation in the national procedure, mutual recognition procedure and decentralised procedure, as well as the method of resolving any arbitration proceedings, the rules of labelling and advertising for traditional herbal medicinal products.
Article 37
(Emergency procedures)
(1) Notwithstanding the provisions of Articles 23 and 25 to 36 hereof, the competent authority may, in order to protect public health in the event of a threat to human life or health, issue ex officio marketing authorisation on the basis of the facts established in the report on the assessment of medicinal product and in the valid marketing authorisation for the medicinal product concerned, obtained from the authority competent for medicinal products in the selected Member State. The marketing authorisation holder in the Member State in which the medicinal product concerned is authorised shall be informed of the application for the issue of marketing authorisation pursuant to this Article.
(2) A wholesaler marketing the medicinal product referred to in the previous paragraph shall be responsible for labelling, package insert, summary of the product characteristics, advertising and pharmacovigilance.
Article 38
(Procedure for obtaining marketing authorization)
(1) The authority competent for medicinal products shall verify the completeness of the application for marketing authorisation within 60 days of receiving it.
(2) The applicant shall enclose with the application, if requested by the authority competent for medicinal products the samples of medicinal product, its starting materials and, if need be, its intermediate products or other constituent materials, which will be submitted to the official control laboratory for establishing the adequacy and reproducibility of control methods used by the manufacturer.
(3) During the evidence-taking procedure prior to the issue of marketing authorisation, the authority competent for medicinal products may order analytical testing of medicinal products in the official control laboratory, assessment of adherence to good practices by persons stated in the documentation, verification of analytical methods aimed at discovering and defining residues of veterinary medicinal products, request additional data and explanations or other relevant evidence.
(4) During the evidence-taking procedure prior to the issue of marketing authorisation, the authority competent for medicinal products must verify compliance with the principles and guidelines of good practices by persons from third countries stated in the documentation.
(5) The Committee on Medicinal Products shall issue an opinion on the quality, safety and efficacy of a medicinal product and the risk/benefit balance which will serve as the basis for drafting the report on the assessment of the medicinal product.
(6) The authority competent for medicinal products shall adopt a decision on the application for marketing authorisation within 210 days of receiving a complete application.
(7) The procedure shall be suspended until the fulfilment of requirements laid down in paragraphs 2 and 3 of this Article within the prescribed deadlines.
(8) Marketing authorisation shall, as a rule, be issued for a period of five years, unless otherwise determined by this Act.
Article 39
(Mutual recognition)
(1) Notwithstanding the provisions of the previous Article, the authority competent for medicinal products shall issue or reject the issue of marketing authorisation in the application for obtaining marketing authorisation according to the mutual recognition procedure or the decentralised procedure on the basis of the assessment report compiled by the reference Member State.
(2) The competent minister shall prescribe the contents of the application, the conditions for obtaining marketing authorisation, the form and contents of the required documentation in the national procedure, mutual recognition procedure or decentralised procedure, as well as more detailed conditions for obtaining marketing authorisation pursuant to Articles 37 and 38 and the first paragraph hereunder.
Article 40
(Conditional marketing authorisation)
In exceptional circumstances and following consultation with the applicant, the authority competent for medicinal products may grant authorisation subject to a requirement for the applicant to introduce specific procedures, in particular concerning product safety, notification to the relevant authorities of any incident relating to its use, and action to be taken. Such authorisation may only be issued for objective and verifiable reasons prescribed by the competent minister. Continuation of the validity of authorisation shall be linked to the annual reassessment of the fulfilment of these conditions. On the basis of positive assessment of the fulfilment of these conditions, the authority competent for medicinal products shall issue a new decision, which shall also be published. The list of requirements shall be made public together with the final deadlines for meeting them.
Article 41
(Scope of marketing authorization)
Notwithstanding the fact whether a separate marketing authorisation is issued for additional strengths, pharmaceutical forms, indications, dosages or other changes or extensions to the marketing authorisation, or an authorisation which is part of the underlying authorisation, all such marketing authorisations resulting from the extension to the underlying authorisation (new indication, new strength, new pharmaceutical form and method of administration and dosage, and in the case of veterinary medicinal products also addition of a new species) shall be treated as part of the same marketing authorisation.

Article 42
(Refused issue of marketing authorization)
(1) The marketing authorization shall be withheld if, during the examination of the documents and particulars, the authority competent for medicinal products establishes that:
- The risk/benefit balance of the medicinal product is not favourable,
- The applicant did not provide sufficient evidence in support of the quality, safety and therapeutic efficacy of the medicinal product,
- Its qualitative and quantitative composition is not in compliance with the documentation, or
- The label or the package insert, submitted by the applicant, is not in accordance with this Act and the regulations issued on the basis hereof.
(2) The marketing authorization shall also be withheld if the authority competent for veterinary medicinal products establishes that:
- The efficacy of the medicinal product is insufficiently substantiated or that the medicinal product is not efficient,
- The withdrawal period recommended by the applicant is not long enough to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer, or is insufficiently substantiated,
- The veterinary medicinal product is offered for sale for a use prohibited under other EU provisions, or
- The veterinary medicinal product is intended for use in one or more species of food producing animals and contains one or more active substances not stated in Annexes I, II or III of the Regulation 2377/90/EEC.
Article 43
(Refused issue of marketing authorization for traditional medicinal product)
The issue of marketing authorization for traditional herbal medicinal product shall be refused if at least one of the following conditions is fulfilled:
- That its qualitative and quantitative composition is not as declared;
- That its therapeutic indications are not in line with the prescribed conditions;
- That the medicinal product could be harmful in normal use;
- That the data on the traditional use of medicinal product are insufficient; in particular, the pharmacological effects or efficacy of the medicinal product are not probable on the basis of long-term use and experience;
- That the quality of the medicinal product is not sufficiently evidenced.

Article 44
(Data on the placement of medicinal products on the market)
(1) The marketing authorisation holder, the holder of marketing authorisation for parallel imported medicinal product and the wholesaler providing parallel distribution of medicinal product shall inform the authority competent for medicinal products, in writing, of the actual beginning of distribution of the medicinal product in the Republic of Slovenia.
(2) The marketing authorisation holder referred to under the previous paragraph shall be obliged to inform the authority competent for medicinal products on any temporary or permanent suspension of such marketing or interrupted supply of such medicinal product at least two months before adopting a decision on suspension of such marketing, except in the case of force majeure.
(3) If requested by the authority competent for medicinal products, the marketing authorisation holder must submit data on the volume of sales and any data available to the holder concerning the scope of medicinal products issued on prescription.
Article 45
(Roll-out period)
(1) If the medicinal product has not been marketed for three consecutive years after the issue of marketing authorisation, such authorisation shall be cancelled.
(2) Notwithstanding the provisions of the previous paragraph, the authority competent for medicinal products shall be entitled not to cancel marketing authorisation in exceptional well-justified cases and for the needs of protecting public health even if the medicinal product has not been actually marketed for three consecutive years after the issue of marketing authorisation.
Article 46
(Changed conditions of marketing authorisation)
(1) After a marketing authorisation has been issued, the authorization holder must, in respect of the methods of manufacture and control, take account of scientific and technical progress and introduce any changes that may be required to enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods. Before introducing any changes, the authority competent for medicinal products must be informed of any new information that could impact the change of marketing authorisation or the change of documentation on medicinal product.
(2) Marketing authorisation holder must inform the authority competent for medicinal products of any data that could impact the assessment of the risk/benefit balance and particularly of any measures, restrictions or prohibitions introduced by other countries.
(3) The authority competent for medicinal products shall accept or refuse the application for marketing authorisation within the deadlines and according to the procedure stipulated by the Regulation 1084/2003/EC.
(4) The competent minister shall determine the documentation and the detailed conditions for dealing with variations or supplements to the marketing authorisation.

Article 47
(Extension of marketing authorisation)
(1) The holder of a marketing authorisation must, no later than six months prior to its expiry, file an application for renewing marketing authorisation.
(2) The validity of marketing authorisation can be extended after the expiry of the five-year period on the basis of the application for extending the marketing authorisation and reassessment of the risk/benefit balance.
(3) The authority competent for medicinal products shall adopt a decision on the extension of marketing authorisation within 90 days of receiving a complete application.
(4) Once the marketing authorisation has been extended for the first time, it shall, as a rule, be valid for an indefinite period of time or until the reasons stipulated hereby no longer exist. The authority competent for medicinal products shall be entitled to decide that another extension of marketing authorisation is required in exceptional cases, for the needs of protecting public health and, providing an explanation for the marketing authorisation holder.
(5) Notwithstanding the provisions of the previous paragraphs, the authority competent for medicinal products shall accept or refuse the application for the extension of marketing authorisation according to the mutual recognition procedure or the decentralised procedure on the basis of the assessment report compiled by the reference Member State.
(6) The competent minister shall determine more specific conditions and contents of the documentation required for extension of marketing authorisation.
Article 48
(Cancellation of and amendments to marketing authorisation for medicinal products for human use ex officio)
(1) The marketing authorization shall be cancelled, withheld or amended if the authority competent for medicinal products for human use establishes that:
- The medicinal product is harmful in normal use;
- The therapeutic efficacy is lacking, i.e. when it is established that therapeutic results cannot be obtained with the medicinal product;
- The risk/benefit balance of the medicinal product is not favourable in the scope of normal use;
- Its qualitative and quantitative composition is not as declared;
- The medicinal product was marketed contrary to the provisions of the marketing authorisation; or
- The medicinal product was marketed contrary to this Act and the regulations issued on the basis hereof or the EU regulations on medicinal products.
(2) Marketing authorisation shall also be suspended, suspended or amended if it is subsequently established that the particulars supporting the application are incorrect, on the basis of applicable regulations, or have not been submitted or supplemented in accordance with such regulations, or where the prescribed controls have not been carried out.
(3) The authority competent for medicinal products shall cancel or suspend the marketing authorisation for a group of medicinal products or all medicinal products for use in human medicine which are produced on the basis of a certain manufacturing authorisation if any of the requirements of such manufacturing authorisation is not met and cancel or suspend the manufacturing authorisation for such group of medicinal products or all medicinal products.
Article 49
(Cancellation of and changes to marketing authorisation for veterinary medicinal products ex officio)
(1) The marketing authorization shall be cancelled, suspended or amended if the authority competent for veterinary medicinal products establishes that:
- The assessment of the risk/benefit balance of such medicinal product is unfavourable in terms of the conditions of use as stated in the marketing authorisation, taking into account above all health and wellbeing of animals and safety of consumers in the event of marketing authorisation for use in zootechnics;
- The medicinal product does not have any therapeutic effect on the species of animal for which the treatment is intended;
- Its qualitative and quantitative composition is not as stated;
- The recommended withdrawal period is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer;
- The medicinal product is offered for sale or advertised for a use prohibited under other applicable regulations;
- The data in the application are incompliant, incorrect, or have not been supplemented in accordance with the regulations, or where the prescribed controls have not been carried out;
- The particulars from the documentation have not been changed in line with the scientific and technological development in the field of medicinal product manufacturing and control;
- The competent authorities have not been submitted new information on any prohibitions or restrictions of the use of medicinal product in any country or new information on the risk/benefit balance;
- The medicinal product was marketed contrary to the provisions of the marketing authorisation; or
- The medicinal product was marketed contrary to this Act and the regulations issued on the basis hereof or the EU regulations on medicinal products.
(2) The authority competent for medicinal products shall cancel or suspend the marketing authorisation for a group of medicinal products or all veterinary medicinal products which are produced on the basis of a certain manufacturing authorisation if any of the requirements of such manufacturing authorisation is not met and cancel or suspend the manufacturing authorisation for such group of medicinal products or all medicinal products.
Article 50
(Sale of medicinal product following the amendment or expiry of marketing authorisation)
(1) A medicinal which has been manufactured or imported prior to the expiry of or amendment to the marketing authorisation may be marketed even after the expiry of the period for which its marketing authorisation was granted until the expiry date of such medicinal product, but for no longer than 18 months after the expiry of or amendment to the marketing authorisation, with the exception of measures taken in accordance with Articles 83 or 84 hereof.
(2) It is prohibited to place on the market any medicinal product whose shelf life has expired or whose quality, safety and efficacy has been found to be deficient.
Article 51
(Documentation as trade secret)
The documentation enclosed in the application for the issue of, amendment to or extension of a marketing authorisation is the property of the applicant and a trade secret, with the exception of data stated in the marketing authorisation and including the summary of product characteristics of the medicinal product, its instructions for use and data on the packaging.
Article 52
(Publication of lists)
(1) Lists of medicinal products for which a marketing authorisation has been issued and lists of medicinal products whose validity has expired or whose marketing authorisation has been amended, extended, suspended or cancelled shall be published by the authority competent for medicinal products in the Official Gazette of the Republic of Slovenia.
(2) The competent minister shall prescribe the contents of the publication stated in the previous paragraph.
Article 53
(Transfer of marketing authorisation)
(1) A marketing authorisation holder may transfer its marketing authorisation to another legal entity or natural person who meets the conditions stipulated hereunder.
(2) The competent minister shall prescribe the procedure for the transfer of marketing authorisation stipulated in the previous paragraph and the necessary documentation and procedure for verifying the prescribed conditions and other necessary evidence.
III. TESTING OF MEDICINAL PRODUCTS
Article 54
(Testing of medicinal products)
(1) Prior to being placed on the market, a medicinal product must undergo analytical and non-clinical pharmacotoxicological tests as well as clinical trials in order to obtain the assessment of its quality, safety and efficacy.
(2) A medicinal product shall undergo analytical and pharmacotoxicological tests as well as clinical trials even if it has already been granted a marketing authorisation or has been marketed, if such testing is performed with the purpose of regular control of medicinal products or for acquiring additional data on that product.
(3) Analytical and non-clinical pharmacotoxicological tests as well as clinical trials may be carried out by legal entities and natural persons (hereinafter: the medicinal product investigation institutions) who satisfy the requirements in terms of staff, facilities, equipment and principles of good practices and hold the licence for performing such activities.
(4) Data on analytical and non-clinical pharmacotoxicological tests as well as clinical trials represent a constituent part of the documentation for obtaining the marketing authorisation.
(5) Analytical and non-clinical pharmacotoxicological tests as well as clinical trials must correspond to contemporary scientific knowledge and principles of good practices. They must be described in sufficient detail so that the tests and trials can be repeated in order to ensure data comparability.
(6) The competent minister shall determine more detailed methods and procedures of analytical and non-clinical pharmacotoxicological tests as well as clinical trials and the requirements which the medicinal product investigation institutions must satisfy as well as the procedures and methods of their verification.
Article 55
(Analytical testing)
Analytical testing shall mean pharmaceutical, chemical and biological quality testing of a medicinal product in compliance with the principles of good laboratory practice and in accordance with the data contained in the documentation for obtaining the marketing authorisation or medicinal product specifications.
Article 56
(Non-clinical pharmacotoxicological testing)
(1) Non-clinical pharmacotoxicological testing shall mean the procedure for establishing the safety of a medicinal product and shall be carried out in compliance with the principles of good laboratory practice and in accordance with the data contained in the documentation for obtaining the marketing authorisation.
(2) Non-clinical pharmacotoxicological testing must define pharmacodynamic, pharmacokinetic and toxicological properties demonstrated on laboratory animals and foresee any possible effects in human beings or target animal species.
(3) The non-clinical pharmacotoxicological testing concerning medicinal products for use in veterinary medicine must provide data on metabolism, kinetics, elimination of medicinal product residues and routine analysis methods that can be applied to determine the level of such residues.
Article 57
(Clinical trials of medicinal products)
(1) Clinical trials of human medicinal products shall mean trials involving healthy and sick human beings, with the purpose of demonstrating or ascertaining any pharmacological or other pharmacodynamic effects of the investigated medicinal product, demonstrating any adverse reactions to it, or investigating its absorption, distribution, metabolism and elimination during investigation with a view to proving its safety and efficacy.
(2) Clinical trials of veterinary medicinal products shall mean the organised study of the effect of a medicinal product on an animal organism with the purpose of demonstrating or ascertaining any pharmacological or other pharmacodynamic effects of the investigated veterinary medicinal product, demonstrating any adverse reactions to it, or investigating its absorption, distribution, metabolism, elimination and residues during investigation with a view to proving its safety and efficacy in target animal species.
Article 58
(Prerequisites for clinical trial)
(1) Medicinal products can be submitted to clinical trials only after the submission of the results on analytical and non-clinical pharmacotoxicological testing of a medicinal product and in the event of investigating a medicinal product that has no impact on the subject's germ line genetic identity.
(2) The procedure for the clinical testing of a medicinal product which is described in the documentation submitted for obtaining marketing authorisation must correspond to the requirements stipulated under Article 54 hereof and the principles of good clinical practice in clinical testing and principles of human medical and veterinary ethics as well as the mandatory and guaranteed protection of personal data.
Article 59
(Conditions for the commencement of a clinical trial)
(1) The applicant for a clinical trial can be either the sponsor of such clinical trial or its representative if the sponsor’s registered office is located outside the European Union in which case the representative’s registered office must be located in the European Union.
(2) Clinical trial can commence once the conditions stipulated by this Act and any regulations arising hereof are fulfilled.
(3) Written authorisation must be issued by the authority competent for medicinal products before commencing clinical trials involving human medicinal products for gene therapy, somatic cell therapy including xenogenic cell therapy and all medicinal products containing genetically modified organisms.
(4) Prior to the commencement of clinical trials of other medicinal products such trials must be notified and the trial can begin if the authority competent for medicinal product does not object within the foreseen deadline.
Article 60
(Liability insurance)
Prior to the commencement of the clinical trial, the applicant for such trial must take up liability insurance for any possible damage resulting from the trial.
Article 61
(Supervision of clinical trial)
Clinical trials performed hereunder shall be supervised by pharmaceutical supervisors holding a university degree in pharmacy, human or veterinary medicine, having additional skills and experience with good clinical practice and meeting the conditions stipulated under the second and the third indent of the first paragraph of Article 102 hereof.
Article 62
(Approval and notification of a clinical trial)
(1) The authority competent for medicinal products shall decide on the applications for approval or notification of a clinical trial. The Committee for Clinical Trials shall issue an opinion on the proposed or notified clinical trial.
(2) The applicant must enclose with the application for a clinical trial of a human medicinal product the opinion of the National Medical Ethics Committee within the ministry competent for health.
(3) The authority competent for medicinal products shall adopt a decision on the application for a clinical trial within 60 days of receiving a complete application. In the case of medicinal products obtained through a biotechnology process, the said deadline can exceptionally be extended for further 30 days. If the application concerns human medicinal products for xenogenic cell therapy no deadline will be laid down for the issue of a decision by the authority competent for medicinal products. Clinical trial can commence once the applicant has received the decision on the approval of such clinical trial.
(4) The authority competent for medicinal products shall adopt a decision on the notification of a clinical trial within 60 days of receiving a complete notification. If there is no response from the competent authority it shall be deemed that the notification has been approved and the clinical trial can commence.
Article 63
(Changes in clinical trial)
(1) In the case of any material changes to ongoing clinical trials, the sponsor must inform the authority competent for medicinal products thereof.
(2) The notified change can be introduced if the authority competent for medicinal products does not issue a negative decision within 35 days of receiving a complete application for such change. In exceptional cases, this period of time may be extended to 60 days.
Article 64
(Discontinuation of a clinical trial)
The authority competent for medicinal products may, for the purpose of protecting public health or health of investigated subjects, order that a trial be temporarily or permanently discontinued.
Article 65
(Payment of expenses arising from trials)
If a clinical trial of a medicinal product with marketing authorisation or marketing authorisation for parallel imported medicinal product is required by an authority competent for medicinal products in order to verify the risk/benefit balance, the costs shall only be borne by the applicant if it turns out that the safety and efficacy correspond to the requirements of the marketing authorisation. In all other events, the costs shall be paid by the marketing authorisation holder.
IV. MANUFACTURING AUTHORISATION FOR MEDICINAL PRODUCTS
Article 66
(Manufacturing of medicinal products)
(1) Legal entities or natural persons may manufacture medicinal products only after they have been granted a manufacturing authorisation and in compliance with such authorisation. The authorisation shall comprise the manufacturing of medicinal products and their sales to wholesalers that have obtained appropriate marketing authorisation and shall be required in the following cases:
- Individual manufacturing processes or the entire production process;
- Individual manufacturing or production unit;
- Individual pharmaceutical forms;
- Manufacturing of active substances;
- For excipients, based on the applicable regulations.
(2) The provisions laid down in the preceding paragraph shall also apply to the manufacturers of medicinal products intended exclusively for exports or clinical trials.
(3)Importers of medicinal products from third countries must also hold manufacturing authorisations.
(4) Manufacturing authorisation shall also include authorisation to distribute by wholesale the medicinal products covered by that authorisation.
Article 67
(Manufacturing conditions)
Legal entities and natural persons manufacturing medicinal products must meet the following conditions:
1. Given the volume and complexity of their medicinal product manufacture, to employ an adequate number of professionals holding university degrees and with an appropriate specialisation in pharmacy, chemistry, chemical technology, medicine, stomatology, veterinary medicine or other appropriate discipline with adequate skills depending on the subject of operations.
2. They must have concluded a contract with an adequately skilled person in charge of releasing the batch of medicinal products to the market who is available at all times. In the case of corporations and groups of companies, it is possible to appoint such person only in one of the members of the group, provided that there exists adequate legal and organisational delimitation of responsibilities and competencies. Such qualified person must have university education in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. The programme of such studies must comprise skills defined by the second paragraph of Article 49 of the Directive 2001/83/EC or the second paragraph of Article 53 of the Directive 2001/82/EC. If the programme of studies does not comprise either of those skills, the qualified person must submit appropriate evidence of having obtained such skills. The qualified person must also have adequate work experience as defined by the third paragraph of Article 49 of the Directive 2001/83/EC or the third paragraph of Article 53 of the Directive 2001/82/EC.
3. They must be equipped with adequate facilities, devices and equipment for the manufacture, control, storage and dispatching and of medicinal products in accordance with the principles of good manufacturing practice.
4. The activity must be performed in accordance with the principles of good manufacturing practice.
5. Only active substances produced in line with good manufacturing practice for starting materials and excipients must be used as starting materials, in accordance with the regulations.
6. They must only provide medicinal products for which marketing authorisation has been issued or medicinal products manufactured or imported in the scope of such marketing authorisation and in line with the applicable regulations.
7. The qualified person referred to under Point 2 hereunder must have the possibility to independently perform its tasks and must have access to all necessary means.
Article 68
(Procedure for obtaining authorisation)
(1) The procedure for the issue of manufacturing authorisation shall be initiated on the basis of an application submitted by a legal entity or a natural person. The application for obtaining a manufacturing authorisation shall contain evidence on the fulfilment of conditions referred to under the previous Article.
(2) The authority competent for medicinal products shall issue or refuse to issue the manufacturing authorisation within 90 days of receiving a complete application on the basis of an opinion issued by the pharmaceutical supervision.
(3) The authority competent for medicinal products may require additional documents or data needed for adopting the decision on the issue of manufacturing authorisation. The procedure shall be suspended until the fulfilment of requirements.
(4) The competent minister shall determine in greater detail the contents of the application and specify the conditions and the procedures for establishing that such conditions for obtaining the marketing authorisation are met as well as the substance and form of the required documentation.
(5) The documentation from the application for obtaining the manufacturing authorisation is a business secret if defined as such by the applicant, in accordance with the regulations.
Article 69
(Certificate of good manufacturing practice)
(1) The manufacturing authorisation holder may require from the authority competent for medicinal products to be issued a certificate of good manufacturing practice.
(2) The procedure for granting or cancelling the certificate of good manufacturing practice shall be prescribed by the competent minister.
Article 70
(Changed conditions for issuing manufacturing authorisations)
(1) The marketing authorisation holder must inform the authority competent for medicinal products of any change in the conditions stipulated under Article 67 hereof which served as the basis for the issue of marketing authorisation.
(2) The deadline for issuing the decision shall be 30 days except in case a specific declaratory procedure is necessary for verifying conditions based on examination. In such cases the deadline for issuing the decision shall be 90 days.
(3) The competent minister shall determine in greater detail the contents of the application for the change of conditions on the basis of which the manufacturing authorisation has been issued and specify the conditions and the procedures for establishing that such conditions for issuing manufacturing authorisation are met.

Article 71
(Cancellation of manufacturing authorisation)
A manufacturing authorisation shall be suspended or cancelled, should the authority competent for medicinal products ascertain that the manufacture of medicinal products no longer satisfies the requirements defined in Article 67 herein and regulations arising hereto.
V. LABELLING AND PACKAGE INSERT
Article 72
(Labelling and package insert)
(1) Information about each medicinal product placed on the market must be written in the Slovene language on its outer packaging or, where there is no outer packaging, on the immediate packaging. Identical information may be given in one or more foreign languages. Data must be legible.
(2) In every medicinal product placed on the market there must be a package insert containing instructions for use in the Slovene language in line with the summary of product characteristics, unless the information required by a regulation is given on the outer packaging or, where there is no outer packaging, on the immediate packaging. Data must be legible and understandable for the user.
(3) Notwithstanding the provisions of the first and the second paragraph hereunder the authority competent for medicinal products may exceptionally allow the use of packaging in a foreign language with a label in the Slovene language and the packaging insert in a foreign language, provided that the insert is enclosed with the medicinal product in the Slovene language in the prescribed manner.
(4) The name of the medicinal product on the packaging must also be printed in Braille. Marketing authorisation holder must ensure that the packaging insert is available in the forms suitable for the blind and the partially sighted, if required by competent patient organisations.
(5) The competent minister shall prescribe a more detailed manner of labelling medicinal products, the form and contents of package insert and the manner of using the labels, special labelling conditions and package inserts for individual medicinal products or groups of medicinal products.
VI. MARKETING OF MEDICINAL PRODUCTS
Article 73
(Wholesale)
(1) Wholesalers in medicinal products may only buy medicinal products from legal entities and natural persons holding appropriate manufacturing or wholesale marketing authorisation.
(2) Wholesalers in medicinal products may only sell medicinal products to legal entities and natural persons holding appropriate retail or wholesale marketing authorisation and pharmacies.
(3) Notwithstanding the provision of the previous paragraph, wholesalers may sell medicinal products directly to health institutions, legal entities or natural persons holding an authorisation issued by the competent authority for performing medical activity, provided that they have established the system for receiving, storing and tracing medicinal products which has been appropriately verified by the competent authority, and appointed a qualified person to receive, store and ensure traceability of medicinal products who holds a diploma, degree or another university or equivalent certificate in the field of pharmaceutical science.
(4) Notwithstanding the provision of the second paragraph hereunder, the wholesalers may sell veterinary medicinal products to veterinary and other organisations which perform veterinary activity in line with the veterinary regulations and authorised manufacturers of medicated feedingstuffs in accordance with the regulations and in the scope covered by their manufacturing authorisation.
(5) Medicinal products referred to in the third paragraph hereunder may only be used for the provision of health services arising from the abovementioned authorisation for performing medical activity.
Article 74
(Conditions for wholesalers)
(1) The wholesale of medicinal products may be undertaken by legal entities and natural persons holding an authorisation issued by the competent authority for performing medical activity and satisfying the following requirements:
1. Have at their disposal the services of professionals, based on contractual relationship, holding a university degree in pharmacy or experts in other disciplines, if necessary.
2. Appoint from among the experts mentioned in the previous point a person in charge of receiving, storing, issuing and transporting medicinal products as well as examining documentation that enables traceability of medicinal products. Such qualified person must hold a university degree in pharmacy.
3. Have at their disposal adequate facilities and equipment, depending on the type of medicinal product that is the subject of wholesale trade.
4. Keep appropriate documentation so as to enable the immediate withdrawal of a medicinal product from the market and resolve complaints.
5. Organise work in accordance with the principles of good distribution practice.
6. Guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a reasonably short time over the whole of the area in question.
7. Have established quality assurance system.
8. Meet the conditions for performing trading activity in accordance with the applicable trade regulations.
(2) If the responsible person stipulated by Point 2 of the previous paragraph does not have a university degree in pharmacy, such person must have obtained additional skills defined by the second paragraph of Article 49 of the Directive 2001/83/EC or the second paragraph of Article 53 of the Directive 2001/82/EC. If the programme of studies does not comprise either of those skills, the qualified person must submit appropriate evidence of having obtained such skills. The qualified person must also have adequate work experience as defined by the third paragraph of Article 49 of the Directive 2001/83/EC or the third paragraph of Article 53 of the Directive 2001/82/EC.
(3) Legal entities or natural persons having obtained the marketing authorisation for wholesaling of medicinal products in another EU Member State and intending to wholesale medicinal products in the Republic of Slovenia can start performing such activity in the Republic of Slovenia once they have notified themselves with the authority competent for medicinal products in accordance with the procedure prescribed by the competent minister.
(4) A distribution authorisation holder must obtain the manufacturing authorisation and meet the conditions stipulated by Article 67 hereof if they plan to manufacture or import medicinal products besides distributing them through wholesale trade.
(5) The competent minister shall determine in greater detail the requirements for the wholesalers of medicinal products as well as the notification procedure in agreement with the minister competent fro trade.
(6) In view of the type of medicinal products in wholesale, the competent minister may prescribe different conditions of wholesale for certain medicinal products.
Article 75
(Issue of authorisation)
(1) The procedure for the issue of distribution authorisation shall be initiated on the basis of an application submitted by a legal entity or a natural person. The application for obtaining a manufacturing authorisation shall contain evidence on the fulfilment of conditions referred to under Article 74 hereof.
(2) The authority competent for medicinal products shall decide on the issue of distribution authorisation within 90 days of receiving a complete application on the basis of an expert opinion issued by the pharmaceutical supervision concerning the fulfilment of conditions.
(3) The authorisation referred to in the previous paragraph may be issued for a limited time or under certain conditions and can be suspended or cancelled should the competent authority ascertain that the holder of distribution authorisation no longer satisfies the prescribed requirements.
Article 76
(Imports)
(1) Medicinal products shall be imported by the manufacturing authorisation holders and wholesalers who, besides the conditions stipulated by Article 74 hereof also meet the conditions prescribed for the manufacturers of medicinal products in respect to the parts of manufacturing procedure they carry out.
(Wholesalers and manufacturing authorisation holders importing medicinal products from third countries and not having themselves the appropriate facilities, equipment and devices for controlling the quality of each imported batch of medicinal product, can enter into a contractual relationship with a legal entity or natural person for the provision of the services of analytical testing of medicinal products, provided that such entity or person holds the authorisation of the authority competent for medicinal products to perform analytical testing of medicinal products.
(3) The batches of medicinal products which have undergone such controls in another EU Member State shall be exempt from the controls prior to their marketing in the Republic of Slovenia, provided that they are accompanied by the control reports signed by the qualified person in charge of batch release.
(4) In the case of medicinal products imported from a country that has entered into Mutual Recognition Agreement with the European Union for the area of medicinal products, the analysis certificate obtained in the exporting country shall be recognised.
Article 77
(Entry and imports of medicinal products)
(1) Entry and imports of medicinal products with:
- Marketing authorization,
- Marketing authorisation for parallel imported medicinal product, or
- Authorisation for clinical trial or adequately notified clinical trial,
need not meet the conditions stipulated by this Act.
(2) Notwithstanding the provisions of the previous paragraph, the entry and import of medicinal products shall only be allowed on the basis of entry authorisation or import authorisation issued by the authority competent for medicinal products within 30 days after receiving a complete application in the following cases:
1. Immunological serums, vaccines, blood products, radiopharmaceuticals;
2. Medicinal products without marketing authorisation in cases of emergency for treatment proposed by a legal entity performing tertiary medical activity or a competent veterinarian of the veterinary organisation and on the basis of personal responsibility of a doctor or veterinarian in charge of individual cases of treatment;
3. Medicinal products stipulated by Article 15 hereof without a marketing authorisation;
4. Medicinal products intended for research and development work at the responsibility of the institution performing such research and development work.
(3) The application for obtaining the entry authorisation referred to in the previous paragraph can be submitted by a wholesaler and for obtaining the import authorisation by a person meeting the requirements for the import of medicinal products.
(4) The competent minister shall determine in greater detail the requirements, methods and procedures governing the entry and imports referred to in the previous paragraph.
Article 78
(Parallel imports of medicinal products)
(1) The procedure for obtaining a marketing authorisation for parallel imported medicinal product shall be initiated on the basis of an application submitted by the importer who is a wholesaler and is not in a business relationship for the marketing of such medicinal product with the holder of marketing authorisation. The authority competent for medicinal products shall issue the marketing authorisation for parallel imported medicinal products within 60 days of receiving a complete application.
(2) The competent minister shall lay down more detailed conditions, method and procedure for obtaining the marketing authorisation for parallel imported medicinal products.
Article 79
(Retail)
(1) Retail trade in medicinal products for human use, accompanied by adequate expert support and advice, shall be carried out in pharmacies and specialised stores, while veterinary medicinal product shall also be sold in veterinary organisations, together with the service provided.
(2) Notwithstanding the provisions of the previous paragraph, only those medicinal products can be sold in specialised retail stores which are not subject to medical or veterinary prescription and are authorised by the authority competent for medicinal products.
(3) When defining medicinal products that can be sold in specialised retail stores, the authority competent for medicinal products may introduce certain restrictions concerning the strengths, packaging sizes and number of units sold.
(4) The authority competent for medicinal products shall only authorise the sales of those medicinal products in specialised retail stores which have a favourable risk/benefit balance and an acceptable pharmacovigilance and toxicovigilance profile.
(5) Medicinal products in specialised retail stores may only be sold to adult persons.
(6) The method and place of issuing medicinal products shall be defined in the relevant marketing authorisation.
(7) Homeopathic medicinal products may only be issued in pharmacies, while veterinary homeopathic medicinal products may also be sold in veterinary organisations, together with the service provided.
(8) Issue based on self-service shall only be allowed in pharmacies and specialised retail stores and shall be limited to medicinal products referred to in the second paragraph hereunder which are of herbal origin.
(9) Sales of medicinal products over the Internet, accompanied by adequate expert support and advice, shall be allowed if performed by a holder of an authorisation for performing such pharmaceutical activity who ensures quality and traceability of medicinal products. The ministry competent for health may recognise such authorisations issued by the competent authorities of the EU Member States.
(10) Besides the responsibility of Internet source of a medicinal product, which includes the liability of manufacturer, wholesaler and retailer, the user or buyer of such medicinal product shall also be responsible for any risks and damages incurred through the use of medicinal products obtained from non-traceable Internet sources or sources that do not correspond to the requirements of the previous paragraph.
(11) The competent minister shall determine the manner of issue and the related classification of the medicinal product.
Article 80
(Pharmacies)
Requirements for marketing medicinal products imposed on pharmacies and Internet pharmacies shall be regulated by a separate act.
Article 81
(Specialised stores)
(1) The retail sale of medicinal products in specialised stores may be undertaken by legal entities and natural persons holding an authorisation issued by the competent authority for performing medical activity and satisfying, besides the general conditions for performing the retail sale activity, also the following requirements:
1. They must employ at least one qualified person with at least level V pharmacy education, who has passed the qualifying examination and is put in charge of purchasing, storing and selling medicinal products and keeping documentation and must be available at all times during the store’s business hours.
2. They must dispose of adequate facilities which must be physically separated from the facilities in which other products are sold, and the necessary equipment.
3. They must keep appropriate documentation so as to enable the immediate recall of a medicinal product from the market and resolve complaints.
(2) The procedure for the issue of retail authorisation for the sale of medicinal products in specialised stores shall be initiated on the basis of an application submitted by a legal entity or a natural person.
(3) The authority competent for medicinal products shall issue a retail authorisation for the sale of medicinal products in specialised stores within 90 days of receiving a complete application on the basis of an expert opinion issued by the pharmaceutical supervision concerning the fulfilment of conditions.
(4) The authorisation referred to in the previous paragraph may be issued for a limited time or under certain conditions and can be suspended or cancelled should the competent authority ascertain that the holder of marketing authorisation no longer satisfies the prescribed requirements.
(5) More detailed requirements for marketing medicinal products imposed on specialised shops retailing medicinal products and the procedure for ascertaining their compliance shall be determined by the competent minister in agreement with the minister competent for trade.
VII. PHARMACOVIGILANCE
Article 82
(Pharmacovigilance system)
(1) Reports on adverse reactions to medicinal products for human use shall be collected and assessed by a legal entity meeting the conditions concerning personnel, facilities and equipment and authorised for performing such activity by the competent minister.
(2) A doctor or another health professional who identifies or suspects any adverse reactions to medicinal products for human use shall inform thereof the legal entity referred to in the previous paragraph in accordance with the applicable regulations.
(3) A veterinarian who identifies or suspects any adverse reactions to medicinal products for veterinary use shall inform thereof the marketing authorisation holder in accordance with this Act and the regulations issued on the basis hereof. In the case of unexpected serious adverse reactions in animals and in human beings related to the use of veterinary medicinal products the authority competent for medicinal products shall also be informed, besides the marketing authorisation holder in accordance with this Act and the regulations issued on the basis hereof.
(4) Holders of marketing authorisations must setup and maintain their own pharmacovigilance systems which guarantee collection, evaluation and exchange of data with the legal entity referred to in the first paragraph hereunder and with the bodies competent for medicinal products in the Republic of Slovenia and the European Union as well as other sources, such as the publications of the World Health Organisation and other professional publications. They must compile reports and perform other tasks within the deadlines and in the way stipulated by Articles 103 and 104 of the Directive 2001/83/EC and Articles 74 and 75 of the Directive 2001/82/EC.
(5) Legal entities referred to in the first paragraph hereunder must regularly submit the collected data on adverse reactions and any other significant data concerning safety and efficacy and use of medicinal products as well as the functioning of the pharmacovigilance system to the authority competent for medicinal products.
(6) The authority competent for medicinal products shall identify and evaluate the adverse reactions to medicinal products and other findings about the safety of medicinal products and take measures with the aim of managing and reducing the risks arising from medicinal products, with expert assistance provided by the legal entity stipulated by the first paragraph hereunder, verify the implementation of the pharmacovigilance system by the marketing authorisation holders and perform tasks in accordance with the provisions of Articles 105, 106 and 107 of the Directive 2001/83/EC and Articles 76, 77 and 78 of the Directive 2001/82/EC.
(7) The provisions of this Article shall not apply to homeopathic medicinal products specified in the second paragraph of Article 14 of this Act. The competent minister may prescribe the pharmacovigilance management system for such homeopathic medicinal products.
(8) The competent minister shall determine in greater detail the conditions for the functioning of the pharmacovigilance system.
Article 83
(Measures taken in the event of inappropriate quality of medicinal products)
(1) Legal entities or natural persons, manufacturing or marketing medicinal products must report all events or suspected events regarding inappropriate quality of medicinal products, which could affect the safety or efficacy of the medicinal product, to the authority competent for medicinal products, the marketing authorisation holder and the legal entity or natural person marketing the medicinal products.
(2) The marketing authorisation holder shall be obliged to withdraw the deficient medicinal product from the market or take any other necessary measures as well as inform, regularly and without delay, the authority competent for medicinal products of any activities taken.
(3) The marketing authorization holder shall be obliged to notify the competent authorities of the EU Member States in which the medicinal product is marketed forthwith of any action taken by him to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market or to suspend or cancel the marketing authorisation, together with the reasons for such action if the latter concerns the efficacy of the medicinal product or the protection of public health.
(4)The authority competent for medicinal products shall monitor and, if necessary, direct the activities of the marketing authorisation holder in relation to the measures taken in the event of inappropriate quality of medicinal products and report to the international rapid alert system.
(5) The authority competent for medicinal products shall immediately inform the European Medicines Agency in the case of taking any measures that could influence the protection of public health in the EU Member States and, if necessary, also the World Health Organisation.
(7) The competent minister shall determine in greater detail the measures to be taken in the case of inappropriate quality.
Article 84
(Measures taken in pharmacovigilance cases)
(1) The provisions of the previous Article shall also apply in the cases of increased risk arising from adverse reactions that could be harmful for the health of people or animals or impact the risk/benefit balance of the medicinal product and should be reported to the international rapid alert system.
(2) The competent minister shall prescribe more detailed measures to be taken in the cases stated in the previous paragraph.
VIII. ADVERTISING OF MEDICINAL PRODUCTS
Article 85
(Advertising of medicinal products)
Advertising of medicinal products shall mean any form of information, including door-to-door information, publication or inducement designed to promote the prescription, issue, sale or consumption of medicinal products.
Article 86
(Terms and conditions of advertising)
(1) The marketing authorisation holders may advertise medicinal products only in accordance with the provisions of this Act and the regulations issued on the basis of this Act.
(2) It is prohibited to advertise medicinal products which have not been granted a marketing authorisation.
(3) All parts of the advertising of a medicinal product must comply with the summary of product characteristics.
(4) Advertising of medicinal products must encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties, and may not be misleading.
Article 87
(Advertising of medicinal products to the general public)
(1) It is only allowed to advertise in the mass media medicinal products dispensed without prescription.
(2) It is prohibited to advertise to the general public the following:
- Medicinal products dispensed only on prescription;
- Medicinal products containing psychotropic or narcotic substances within the meaning of international conventions, such as the United Nations Convention on narcotic drugs of 1961 and the United Nations Convention on psychotropic substances of 1971.
(3) The advertising of a medicinal product to the general public shall not contain any material which:
- Gives the impression that a medical or veterinary consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail;
- Suggests that the effects of taking the medicine are absolutely guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicinal product;
- Suggests that the health of the person or animal can be enhanced by taking the advertised medicine;
- Suggests that the health of the person or animal could deteriorate by not taking the advertised medicine; this prohibition shall not apply to the vaccination programmes;
- Is directed exclusively or principally at children;
- Refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products;
- Suggests that the medicinal product is a foodstuff, cosmetic or other consumer product;
- Suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural;
- Could, by a description or detailed representation of a case history, lead to erroneous self-diagnosis;
- Refers, in improper, alarming or misleading terms, to claims of recovery; or
- Uses, in improper, alarming or misleading terms, pictorial representations of changes in the human or animal body caused by disease or injury, or of the action of a medicinal product on the human or animal body or parts thereof;
(4) Direct distribution of medicinal products to the end users for promotional purposes shall be prohibited.
Article 88
(Advertising of medicinal products to the expert community)
(1) Holders of marketing authorisations may advertise medicinal products with marketing authorisation in scientific literature, professional journals and other professional publications, as well as directly inform experts who prescribe or dispense medicinal products.
(2) Where medicinal products are being promoted to expert community, i.e. persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine, veterinary medicine or pharmacy. The value of gifts, pecuniary advantages or small benefits in kind may not exceed the value prescribed for civil servants.
(3) Organisation and implementation of promotional meetings must be strictly limited to the professional purpose of the meeting which includes obtaining of new skills and knowledge on new medicinal products and may only be provided to persons authorised to prescribe and issue medicinal products.
(4) Marketing authorisation holders, manufacturers of medicinal products, legal entities and natural persons acting on behalf of manufacturers and legal entities and natural persons marketing medicinal products, as well as subsidiaries of foreign manufacturers may enable persons who prescribe or issue medicinal products to acquire knowledge on new medicinal products in scientific and expert meetings, however, only in the scope of restrictions referred to in the second and the third paragraph hereunder.
(5) Persons qualified to prescribe or supply medicinal products shall not solicit or accept any inducement prohibited under the second and the third paragraph hereunder.
(6) The marketing authorization holder shall be obliged to establish a scientific service for advertising medicinal products with medical experts to advertise medical experts to persons prescribing and issuing medicinal products. Such experts for human medicinal products must hold a university degree in pharmacy or human medicine or a university degree in natural sciences or biomedicine with additional skills in medicinal products. Such experts for veterinary medicinal products must hold a university degree in pharmacy or veterinary medicine or a university degree in natural sciences or biomedicine with additional skills in medicinal products.
(7) The competent minister shall determine in greater detail the conditions and method of advertising.
Article 89
(Advertising in extraordinary cases)
(1) The competent minister may, by way of exception and in the interest of the general public, with a view to preventing an epidemic, an epizootic, or in case of a natural disaster or in other similar emergencies, allow or approve information about the use of certain medicinal products to be distributed to the mass media.
(2) In the cases referred to in the previous paragraph concerning veterinary medicinal products, the competent minister shall allow or authorise informing on the use of certain medicinal products in public media in agreement with the minister competent for veterinary medicine.
(3) The authority competent for medicinal products may allow advertising of medicinal products used in vaccination programmes to the general public.
Article 90
(Official records of the authority competent for medicinal products)
(1) The authority competent for medicinal products shall keep official records of:
1. Data on medicinal products arising from marketing authorisation based on the type and classification of medicinal products (name, pharmaceutical form, strength, packaging, marketing authorisation holder, manufacturer, applicable price);
2. Data on medicinal products arising from marketing authorisation for parallel imported medicinal products (name, pharmaceutical form, strength, packaging, holder of marketing authorisation for parallel imported medicinal products, manufacturer, applicable price);
3. Data on medicinal products arising from entry or import authorisation (name, pharmaceutical form, strength, packaging, entry authorisation holder, manufacturer);
4. Data on marketing authorization holder (name and legal form of organisation, registered office, name and surname of qualified person responsible for pharmacovigilance);
5. Data on manufacturing authorization holder (name, registered office and legal form of organisation, name and surname of qualified person in charge of releasing the batch of medicinal products to the market);
6. Data on distribution authorization holder (name and legal form of organisation, registered office, name and surname of qualified person in charge of receiving, storing and transporting medicinal products as well as examining documentation);
7. Data on notified foreign wholesalers (name and legal form of organisation, registered office, name and surname of qualified person in charge of receiving, storing and transporting medicinal products as well as examining documentation);
8. Data on retail authorization holder (name and legal form of organisation, registered office, name and surname of qualified person in charge of purchasing, storing and selling medicinal products as well as keeping documentation);
9. Data on the holders of marketing authorisations for parallel imported medicinal products (name and legal form of organisation, registered office, name and surname of qualified person responsible for pharmacovigilance).
(2) The authority competent for medicinal products shall publish professional and general informative publications in its areas of competence.
IX. OFFICIAL QUALITY CONTROL OF MEDICINAL PRODUCTS
Article 91
(Official control laboratory)
(1) Official control laboratory shall mean a legal entity or a natural person complying with the requirements set in the third paragraph of Article 54 hereof, appointed by the competent minister for verifying whether the official quality of medicinal products, which is a member of the European network of official control laboratories or which annually participates in the intra-laboratory verification organised by the European Directorate for the Quality of Medicines and the results achieved are in compliance with the organiser’s requirements.
(2) The competent minister shall prescribe more detailed conditions regarding personnel, facilities, equipment and fulfilment of standards prescribed for quality control of medicinal products, compliance with the principles and guidelines of good laboratory practice and management of quality system.
Article 92
(Types of official controls)
(1) Official quality control of a medicinal product shall mean the process in which the official control laboratory establishes the quality of medicinal product on the basis of analytical testing of certificates, packaging, package insert or other documents.
(2) This Act stipulates the following types of official quality controls of a medicinal product:
- Regular quality controls of all medicinal products, performed in respect to each medicinal product ex officio at least once in five years for each of its pharmaceutical forms and strengths;
- Extraordinary quality controls of medicinal products i.e. quality controls upon the request of the authority competent for medicinal products or pharmaceutical supervisor;
- Special quality controls performed prior to the placing on the market of each batch of risk medicinal products, i.e. immunal serums and vaccines, immunoglobulins and blood products on the basis of the proposal submitted by the marketing authorisation holder or the applicant stipulated under the third paragraph of Article 77 hereof, if no marketing authorisation has been issued for the medicinal product;
- Quality controls of each first batch of medicinal product before it is put on the market, carried out on the basis of the proposal submitted by the marketing authorisation holder, in the case of medicinal products imported from third countries which have not entered into Mutual Recognition Agreement with the EU;
- Quality controls of medicinal products required by the authority competent for medicinal products in the framework of the procedure for obtaining marketing authorisation;
- Quality controls of each first batch of medicinal product with marketing authorisation for parallel imported medicinal product.
Article 93
(Medical report)
(1) The official control laboratory shall issue a medical report on the performed quality control of a medicinal product with assessed quality of the medicinal product which shall be submitted to the authority competent for medicinal products, the pharmaceutical supervision, the marketing authorisation holder or the applicant requesting control.
(2) The samples and costs of official quality control specified in the second paragraph of the previous Article shall be paid by:
- In the case of regular quality control, the marketing authorisation holder or the holder of marketing authorisation for parallel imported medicinal product;
- In the case of extraordinary quality control, the marketing authorisation holder for the medicinal products with such authorisation and the wholesaler for the medicinal products without such authorisation, if it turns out that the quality of a medicinal product is deficient. If it turns out that the quality of a medicinal product is adequate, the costs will be paid by the applicant for such extraordinary quality control;
- In the case of special quality control, the marketing authorisation holder for the medicinal products with such authorisation and the applicant stipulated under the third paragraph of Article 77 hereof for the medicinal products without such authorisation;
- In the case of quality controls of each first batch of medicinal products imported from third countries, prior to placing them on the market, the marketing authorisation holder;
- In the case of quality controls of medicinal products required in the framework of the procedure for obtaining marketing authorisation, the applicant specified in Article 22 hereof;
- In the case of quality controls of each first batch of medicinal product with marketing authorisation for parallel imported medicinal product, the holder of marketing authorisation for parallel imported medicinal product.
(3) The competent minister shall determine the substance and the deadlines of official quality controls of medicinal products, the sampling method and the price of service.
X. FEES
Article 94
(Fees)
(1) The applicant shall pay the fees for the procedures stipulated hereunder, unless otherwise stipulated hereby.
(2) The holders of marketing authorisations or the authorisations for parallel import of medicinal products and the holders of authorisation to perform activity, issued by the authority competent for medicinal products, shall also pay the annual fees for the monitoring of medicinal products on the market concerning individual medicinal products depending on the number of pharmaceutical forms.
(3) Legal entities and natural persons who submitted the applications for expert advice with the authority competent for medicinal products in accordance with Article 24 hereof, shall be obliged to pay the prescribed fees.
(4) The competent minister shall determine the amount of such fees.
XI. PRICES OF MEDICINAL PRODUCTS
Article 95
(Price formation)
The prices of medicinal products are not regulated and follow the market conditions unless in cases stipulated herein.

Article 96
(Price monitoring)
In the interest of protecting public health, the competent minister or the minister competent for veterinary medicine may determine certain medicinal products or groups of medicinal products the prices of which are determined by the authority competent for medicinal products.
Article 97
(Price determination)
(1) The prices of medicinal products for human use with marketing authorisation, authorisation for parallel import of medicinal products, as well as medicinal products without marketing authorisation but with entry or import authorisation which are included in the list stipulated by Article 15 hereof and are financed from public funds, are formed or determined according to the method specified by the competent minister.
(2) The prices of veterinary medicinal products with marketing authorisation or entry or import authorisation, the level of which could impact animal health care or harm the health of human beings, may in exceptional cases be formed or determined according to the method specified by the competent minister for veterinary medicine.
(3) The formation or determination of the prices of medicinal products from the previous paragraph may be prescribed at any level of medicinal product marketing.
(4) The competent minister may also request any data needed for determining the prices of medicinal products from the marketing authorisation holders and entry or import authorisation for medicinal products the prices of which are covered from public funds.
(5) The provisions of secondary legislation stated under the first and the second paragraphs hereunder, concerning the role of the competent authority, shall be implemented by the authority competent for medicinal products.
Article 98
(Application for the formation or determination of the prices of medicinal products)
(1) The application for the notification of the formed prices or price determination on the basis of secondary legislation stipulated under the previous article must be submitted by the marketing authorisation holders, the holders of authorisation for parallel imported medicinal products, and entry or import authorisation holders.
(2) The authority competent for medicinal products must resolve the complete application referred to in the previous paragraph within 90 days of receiving a complete application. In the case of excessive workload related to the number of applications, the authority may extend the deadline for resolving the application once, by a maximum of 30 days. If a decision is not issued within the abovementioned deadline(s), it shall be deemed that the applicant may market the medicinal product at the proposed price.
(3) If the Government adopts a measure of price regulation by determination of fixed prices of all medicinal products or individual groups of medicinal products, the marketing authorisation holder may address to the ministry competent for price regulation an application, together with the explanation, for examining the introduced price regulation measure. The ministry competent for price regulation shall be obliged to resolve the application within 90 days of receiving the complete application.
(4) Should the ministry competent for price regulation establish that the application for examining the introduced price regulation measure is not grounded, the marketing authorisation holder may submit an application to the government itself.
Article 99
(Obligation to use the applicable price)
The participants in the marketing of a medicinal product whose price is formed or determined on the basis of the secondary legislation referred to in Article 97 hereof must use the price of the medicinal product stipulated by such regulation in the marketing of such medicinal product.
Article 100
(Obligation to report other data)
Legal entities and natural persons authorised to market medicinal products or holding an appropriate evidence, specified in the third paragraph of Article 74 hereof must submit to the authority competent for medicinal products all data on the prices of medicinal products in a manner stipulated hereby, while data on veterinary medicinal products must also be submitted to the authority competent for veterinary medicine.
XII. SUPERVISION
Article 101
(Competences in supervision)
(1) Expert supervision in the field of medicinal products shall be carried out by the authority competent for medicinal products in the framework of pharmaceutical supervision. The tasks of pharmaceutical supervision shall be performed by the pharmaceutical supervisors.
(2) The official veterinarians supervise the implementation of the provisions of this Act and regulations issued on the basis of this Act relating to the use of medicinal products and the related traceability of veterinary medicinal products.
(3) The market inspectors supervise the implementation of the provisions of this Act and regulations issued on the basis of this Act relating to the prices of medicinal products.
Article 102
(Pharmaceutical supervisors)
(1) In order to be appointed a pharmaceutical supervisor, a person must satisfy the following criteria:
- Hold a university degree in pharmacy or other natural sciences with additional skills in good practices;
- Have at least 5 years of work experience;
- Have has passed a professional examination for a pharmaceutical supervisor.
(2) The supervisors shall be designated by the authority competent for medicinal products in accordance with the Civil Servants Act.
(3) When performing their tasks in accordance with their authorities, the supervisors shall be independent and shall perform such tasks in the scope and on the basis of the constitution and the law and always obliged to use their professional skills, educate further and participate in the training and examinations.
(4) The minister competent for health shall prescribe the contents and procedures of the expert examination for a pharmaceutical supervisor, as well as the contents and method of examining the skills and qualification of pharmaceutical supervisors.
Article 103
(Customs supervision)
The import of medicinal products shall be supervised by the customs authorities with expert support provided by the authority competent for medicinal products and the official veterinarians.
Article 104
(Competences of pharmaceutical supervisors)
(1) Pursuant to this Act, the pharmaceutical supervisors shall have the following competences and tasks:
- Conduct the violations procedure and impose sanctions for such violations;
- Order a legal entity or natural person to bring their operations in line with the requirements previously set out in this Act and the regulations arising hereof within a period of no more than six months since the receipt of the order calling for this measure;
- Ban the manufacture, testing or marketing of medicinal products on the grounds of non-conformity with prescribed conditions;
- Withhold marketing of a medicinal product or a particular batch which does not satisfy the prescribed conditions, is harmful if used in the prescribed way, has no therapeutic effect or its risk/benefit balance is not favourable if used in the prescribed way;
- Order destruction of a deficient medicinal product;
- Ban the entry or import of a medicinal product which has not been granted a marketing authorisation by the authority competent for medicinal products or has been transported against the manufacturer's instructions;
- Order the removal or destruction of the material used for illegal advertising of medicinal products;
- Prohibit the advertising of medicinal products that is not in compliance with the provisions of this Act;
- Order other measures necessary for the implementation of this Act and the regulations arising hereto.
(2) The pharmaceutical supervisor shall be independent in performing the supervision tasks, conducting and deciding in the administrative and violation procedure and shall identify in the performance of such tasks with the certificate issued by the director of the authority competent for medicinal products on the allocation to the post of pharmaceutical supervisor.
(3) In the scope of the tasks of supervising legal entities and natural persons, the pharmaceutical supervisor shall be entitled to do the following:
- Inspect the premises, facilities, installations, devices, equipment, fixtures, items, goods, substances, books of account, contracts, documents and other records as well as operations and documentation of government bodies, companies, institutions, organisations, communities and private individuals,
- Inspect the books of account, contracts, documents and other records as well as operations and documentation kept on the electronic media and demand hard copies thereof, which must be authentic in respect to the electronic form,
- Inspect the documents that prove the identity of persons,
- Obtain, free of charge, and use any personal or other data from official records and other databases related to the person concerned and needed for conducting pharmaceutical supervision,
- Take free samples of goods, materials and equipment and examine the samples taken,
- Take photographs or record on any other visual data carrier the data on persons, premises, facilities, installations, fixtures and other items stated under the first indent,
- Reproduce documents, audiovisual records and other evidence,
- Confiscate items, documents and samples to protect evidence,
- Do anything else in accordance with the aim of such pharmaceutical supervision.
(4) The pharmaceutical supervisor shall be entitled to enter the premises and facilities, and access the equipment and devices mentioned in the previous Article, unless otherwise stipulated hereby, without prior notification to the subject of inspection or its responsible person and regardless of the business hours.
(5) If, for no grounded reason, the person who is the subject of inspection refuses access to the premises or facilities in which the activity is performed, the pharmaceutical supervisor shall be entitled to enter the premises in spite of refused access. The costs of such entry and potential unavoidable damage shall be covered by the subject of inspection.
(6) An appeal against the measures stipulated under previous paragraphs, ordered by the pharmaceutical supervisor shall not prevent their implementation.
(7) Should a pharmaceutical supervisor establish any violations in the area of the use of veterinary medicinal products, the authority competent for veterinary medicine shall be informed thereof immediately.
(8) Should the pharmaceutical supervisor encounter any physical resistance during the pharmaceutical supervision, or if such resistance is expected, police assistance may be requested. The police shall provide assistance to pharmaceutical supervisors in accordance with the regulations on police.
Article 105
(Competence of market inspectors)
(1) If the persons marketing medicinal products failed to comply with the applicable prices, the market inspector shall be entitled to issue a decision and demand the following:
- That they use the applicable price,
- That they refund the undue amounts resulting from the difference in the price, with accrued interest.
(2) If the persons marketing the medicinal product failed to comply with the price stipulated on the basis of the secondary legislation stipulated under Article 97 hereof and charged too high prices to the payers, such persons shall be obliged to refund such unduly charged amounts to the payers within 15 days of the issue of a final decision by the market inspection authority, together with the accrued interest, without a specific request.
(3) Interest stipulated hereunder shall equal the default interest in economic transactions based on the law of obligations.
(4) The market inspection authority shall inform of its decision the authority competent for medicinal products or, in the case of veterinary medicinal products, also the minister or authority competent for veterinary medicine.
Article 106
(Competences of official veterinarians)
The official veterinary shall, in addition to rights and tasks set out in other regulations on inspection, also have the following competence to:
1. Conduct the violations procedure and impose sanctions for such violations.
2. Impose on the legal entity or natural person to harmonise the operations with the provisions of this Act and the regulations adopted on its basis.
Article 107
(Obligation to supply the market in accordance with the decision issued by a market inspector)
(1) If the persons marketing the medicinal product fail to start or stop selling a medicinal product on the basis of secondary legislation stipulated by Article 97 hereof upon their own initiative and if such action could seriously jeopardise the supply of medicinal products to the population, the market inspector may issue a decision specified in the first paragraph of the previous Article imposing on them to immediately start or continue selling such medicinal product, applying the prices stipulated on the basis of the secondary legislation defined under Article 97 hereof.
(2) In such decision, the market inspector shall lay down a deadline by which the persons marketing medicinal products must meet the obligation stipulated under the previous paragraph; nevertheless, such obligation may not last more than three months after the issue of the final decision by the market inspection authority.
Article 108
(Execution of decisions)
An appeal against the decision stipulated in Article 105 hereof shall not prevent its execution with the exception of refunding the unduly charged amounts in accordance with the second paragraph of the same Article.

XIII. PUBLIC AGENCY FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES
Article 109
(Foundation of the Public Agency)
(1) For the performance of tasks stipulated by this Act and the act regulating medical devices the Public Agency for medicinal products and medical devices of the Republic of Slovenia (hereinafter: the Public Agency) shall be founded as a public law entity.
(2) The founder of the Public Agency shall be the Republic of Slovenia. The rights of the founder shall be exercised by the Government.
(3) The ministry in charge of health shall exercise supervision over the work of the Public Agency.
(4) The provisions of the act regulating public agencies shall apply to the Public Agency, unless otherwise provided by this Act.
(5) The Public Agency for medicinal products and medical devices shall take over the tasks and competences Agency for medicinal products and medical devices of the Republic of Slovenia established within the Ministry of Health and the tasks of the official control laboratory stipulated under Article 91 hereof.
Article 110
(Tasks of the Public Agency)
The Public Agency shall perform the following tasks:
- Administrative, professional and development activities in the area of medicinal products and medical devices for human and veterinary use with the exception of defining doctrinal solutions in terms of safe use of medicinal products in veterinary medicine;
- Supervision in the area of medicinal products and medical devices for human and veterinary use with the exception of supervising the marketing of medicinal products used in veterinary medicine;
- The tasks of official control laboratory;
- Execution and adoption of decisions in national and European harmonised administrative and professional procedures of assessing quality, safety and efficiency of medicinal products and medical devices;
- The tasks of establishing, upgrading and modernising the regulatory information system and keeping official records on the basis of this Act;
- The tasks of pharmacovigilance and materiovigilance systems;
- The tasks of establishing internationally recognised quality system in the framework of good regulatory practice;
- The tasks in the area of determining, monitoring and analysing the prices of medicinal products and their impact on the functioning of the market;
- Expert support in the implementation of system orientations in the area of medicinal products and medical devices;
- The tasks that involve co-operation with other management, expert and scientific institutions.
Article 111
(Sources for the functioning of the Public Agency)
(1) The sources needed for the functioning of the Public Agency are:
- Fees;
- Income from the provision of official quality control services as stipulated under Article 93 hereof;
- Income from the provision of other expert services; and
- Funds from the budget of the Republic of Slovenia.
(2) The funds from the budget of the Republic of Slovenia shall only be granted for the provision of those services of the Public Agency the financing of which is not covered by the funds obtained from other sources on the basis of the Action Plan of the Public Agency, approved by the Government.
Article 112
(Bodies of the Public Agency)
(1) The bodies of the Public Agency shall be its Director and the Council of the Public Agency.
(2) The composition and the number of council members shall be determined by the founder in the Articles of Association.
(3) The Director and the council members may not be either employed by, or perform any form of work in, any organisation engaged in any form of for-profit activities activity in the area of medicinal products and medical devices, and may not have any function whatsoever in such organisations.
(4) Besides the reasons, stipulated by the act regulating public agencies, the Government shall dismiss the Director or a council member of the Public Agency also in the following cases:
- If the Director is declared unfit to conduct business or becomes incapable of performing the function for health reasons,
- If the grounds from the third paragraph of this Article arise,
- In the event of final judgement sentencing the Director to imprisonment for a criminal offence or for causing economic losses.
Article 113
(Reporting on the work of the Public Agency)
(1) At least once a year and no later than by 30 June, for the previous year, the Public Agency shall submit to the Government a report on its work and the situation in the field of medicinal products and medical devices.
(2) The Public Agency shall make the report from the first paragraph hereunder available to the public. Before the publication, the personal data and any data constituting a business secret shall be removed from the report.
Article 114
(Administrative decisions of the Public Agency)
(1) Pursuant to this Act, the Public Agency shall adopt administrative decisions in the administrative procedure at the first instance.
(2) The Public Agency shall perform all the tasks of the authority competent for medicinal products, stipulated hereby and any secondary legislation adopted on its basis or other applicable laws or regulations.
(3) Appeals against the decisions adopted by the Public Agency shall be decided on by the ministry competent for health, with the exception of the decisions falling within the competence of the market inspector, as stipulated herein, which shall be decided on by the ministry competent for the market.
(4) The Public Agency shall be the authority responsible for violations in the area of medicinal products and medical devices.
(5) A violations procedure shall be conducted and decided upon by an authorised official of the Public Agency, who fulfils the conditions laid down in the act regulating violations, and regulations adopted on the basis thereof.
XIV. PENALTY PROVISIONS
Article 115
(Sanctions for violations)
(1) A fine of between SIT 100,000 and SIT 500,000 shall be imposed on a legal entity or a natural person for committing a violation, as specified in Point 10 of Article 6 hereunder:
1. Act contrary to the fourth or the fifth paragraph of Article 82 hereof;
2. Act contrary to Article 100 hereof;
3. Act contrary to the second paragraph of Article 16, Point (d) of the second paragraph of Article 23, the fifth paragraph of Article 24 and Article 26 of the Regulation 726/2004/EC.
(2) A fine of between SIT 10,000 and SIT 50,000 shall be imposed on the responsible person of the legal entity or the natural person specified in the previous paragraph for committing a violation, as specified in Point 10 of Article 6 hereunder.
Article 116
(Sanctions for violations)
(1) A fine of between SIT 1,000,000 and SIT 25,000,000 shall be imposed on a legal entity or a natural person for committing a violation, as specified in Point 15 of Article 6 hereunder:
1. Act contrary to Article 44 hereof;
2. Perform the wholesale of medicinal products contrary to Article 73 hereof;
3. Perform the retail of medicinal products contrary to Article 79 hereof.
(2) A fine of between SIT 50,000 and SIT 500,000 shall be imposed on the responsible person of the legal entity or the natural person specified in the previous paragraph for committing a violation, as specified in Point 15 of Article 6 hereunder.
Article 117
(Sanctions for violations)
(1) A fine of between SIT 2,000,000 and SIT 30,000,000 shall be imposed on a legal entity or a natural person for committing a violation, as specified in Point 15 of Article 6 hereunder:
1. Act contrary to Articles 17 or 18 hereof;
2. Act contrary to Articles 11 and 12 hereof;
3. Act contrary to the second paragraph of Article 37 hereof;
4. Act contrary to the first paragraph of Article 46 hereof;
5. Act contrary to Article 50 hereof;
6. Act contrary to Article 54 hereof;
7. Act contrary to the second, third or fourth paragraph of Article 59 hereof;
8. Act contrary to Articles 66 or 67 hereof;
9. Act contrary to Article 72 hereof;
10. Act contrary to Article 74 hereof;
11. Act contrary to Article 76 hereof;
12. Act contrary to Articles 77 or 78 hereof;
13. Act contrary to Articles 79 and 81 hereof;
14. Act contrary to the first, second or third paragraph of Article 83 hereof;
15. Act contrary to Articles 86, 87 or 88 hereof;
16. Act contrary to Article 99 hereof.
(2) A fine of between SIT 100,000 and SIT 1,000,000 shall be imposed on the responsible person of the legal entity or the natural person specified in the previous paragraph for committing a violation, as specified in Point 15 of Article 6 hereunder.
Article 118
(Sanctions for violations)
(1) The Official Control Laboratory shall be punished by a fine of between SIT 1,000,000 and SIT 10,000,000 for acting contrary to Articles 93 and 76 of this Act.
(2) The responsible person of the Official Control Laboratory shall be punished by a fine of between SIT 50,000 and SIT 500,000 for an offence from the preceding paragraph.
Article 119
(Sanctions for violations)
A legal entity or a natural person specified in Point 15 of Article 6 hereunder who have been fined for committing violations listed in Articles 115, 116, 117 and 118 and who failed to pay the fine after the issue of a final decision, shall not be issued or extended an authorisation under the administrative procedure or a certificate regulated by this Act.
XV. TRANSITIONAL AND FINAL PROVISIONS
Article 120
(Deadline for the foundation of the Public Agency)
(1) The Government of the Republic of Slovenia shall found the Public Agency for medicinal products and medical devices stated in the third paragraph of Article 2 of this Act not later than one year after the enforcement of this Act.
(2) Until the foundation of the Public Agency for medicinal products and medical devices, the tasks of the authority competent for medicinal products shall be performed by the authority within the ministry competent for health.
(3) Until the foundation of the Public Agency for medicinal products and medical devices, the tasks of the official control laboratory shall be performed by the Institute of Pharmacy and Drug research - Ljubljana.
(4) The personnel, premises and equipment needed for starting the operations of the Public Agency for medicinal products and medical devices shall be provided by merging the resources of the Agency for medicinal products and medical devices of the Republic of Slovenia established within the Ministry of Health and the Institute of Pharmacy and Drug research - Ljubljana. Funds required for the starting the operations of the Public Agency shall be granted from the budget of the Republic of Slovenia.
(5) The Public Agency for medicinal products and medical devices shall take over all the employees who, at the day the Public Agency is founded, are employed by the Agency for medicinal products and medical devices of the Republic of Slovenia established within the Ministry of Health and the Institute of Pharmacy and Drug research – Ljubljana, including the equipment and assets, unfinished business, archives and records.
(6) The pharmaceutical inspectors working in the framework of the Agency for medicinal products and medical devices of the Republic of Slovenia established within the ministry competent for health shall, as of the day of the establishment of the Public Agency for medicinal products and medical devices, start performing the tasks of pharmaceutical supervisors in accordance with this Act.
Article 121
(Issue of implementing regulations)
(1) The deadline for the issue of implementing regulations hereunder shall be two years of the enforcement hereof, with the exception of regulations related to the implementation of the provisions stipulated by the Directive 2001/83/EC and the Directive 2001/82/EC which must be issued within one month of the enforcement hereof.
(2) Until the implementation of the implementing regulations issued on the basis of this Act, the following implementing regulations shall be used, issued on the basis of the Medicinal Products and Medicinal Devices Act (Official Gazette of the Republic of Slovenia nos. 101/99, 70/00, 7/02, 13/02 – ZKrmi, 67/02 and 47/04 – ZdZPZ), provided that they are not contrary to this Act or if not otherwise stipulated hereby:
- Rules on the Classification, Prescribing and Dispensing of Medicinal Products for Human Use (Official Gazette of the Republic of Slovenia nos. 59/03 and 114/03);
- Rules on the conditions to be met by analysts in analytical testing of medicinal products and procedure for the verification of these conditions (Official Gazette of the Republic of Slovenia, no. 43/00);
- Rules on pharmacological and toxicological testing of medicinal products (Official Gazette of the Republic of Slovenia, no. 44/00);
- Rules on clinical trial of medicinal products (Official Gazette of the Republic of Slovenia, no. 67/00),
- Rules on procedures relevant to the marketing authorization of medicinal products (Official Gazette of the RS, nos. 60/04, 77/04 and 103/05);
- Rules on the conditions and the procedure for obtaining a special authorisation for the import of medicinal products and devices (Official Gazette of the Republic of Slovenia, no. 72/00);
- Rules on analytical testing of medicinal products (Official Gazette of the Republic of Slovenia, no. 73/00);
- Rules concerning the requirements to be met by specialized shops for retail trade in medicinal products and on the procedure for ascertaining their compliance (Official Gazette of the Republic of Slovenia, nos. 73/00 and 54/03);
- Rules on labelling of medicinal products and on patient information leaflet (Official Gazette of the Republic of Slovenia, no. 82/00);
- Rules on the detailed conditions to be met by the manufacturer of medicinal products for human use and on the procedure for the verification of the manufacturer (Official Gazette of the Republic of Slovenia, no. 51/04);
- Rules on pharmacovigilance (Official Gazette of the Republic of Slovenia, no. 94/00);
- Rules on the methodology of pricing and quality control of medicinal products (Official Gazette of the Republic of Slovenia, no. 113/00);
- Rules on immunological medicinal products (Official Gazette of the Republic of Slovenia, no. 2/01);
- Rules on therapeutic substances of human origin (Official Gazette of the Republic of Slovenia, no. 2/01);
- Rules on radiopharmacological products (Official Gazette of the Republic of Slovenia, no. 7/01);
- Rules on wholesale pricing standards for medicinal products and the method of informing about wholesale prices of medicinal products (Official Gazette of the Republic of Slovenia, no. 69/05);
- Rules on the advertising of medicinal products and medical devices (Official Gazette of the Republic of Slovenia, no. 76/01);
- Rules on homeopathic products (Official Gazette of the Republic of Slovenia, no. 90/04);
- Rules on analytical testing of medicinal products for human use to perform state control of their quality (Official Gazette of the Republic of Slovenia, no. 74/04);
- Rules on detailed conditions of wholesale of medicinal products (Official Gazette of the Republic of Slovenia, no. 75/03);
- Rules classifying vitamin and mineral products for oral use that are in a pharmaceutical form as medicinal products (Official Gazette of the Republic of Slovenia, no. 83/03);
- Rules on costs (Official Gazette of the Republic of Slovenia, no. 74/05);
- Rules determining good manufacturing practice (Official Gazette of the Republic of Slovenia, no. 10/05);
- Rules on the principles of good laboratory practice (Official Gazette of the Republic of Slovenia, nos. 38/00 and 2/04);
- Rules on the assessment and procedures for compliance monitoring of the principles of good laboratory practice (Official Gazette of the Republic of Slovenia, no. 38/00);
- Rules on the classification of medical plants (Official Gazette of the Republic of Slovenia, no. 133/03);
- Rules on the specific part of the examination for pharmaceutical inspectors (Official Gazette of the Republic of Slovenia, no. 52/05);
- Order on the determination of medicinal products issued with or without prescription (Official Gazette of the Republic of Slovenia, no. 110/99);
- Order on permitted colouring agents (Official Gazette of the Republic of Slovenia, no. 72/00);
- Order appointing a legal person for pharmacovigilance and medical devices vigilance (Official Gazette of the Republic of Slovenia, no. 100/00);
- Order setting out a uniform national nomenclature of therapeutic agents and the system classifying medicinal drugs according to their anatomic-therapeutic-chemical classification (Official Gazette of the Republic of Slovenia, no. 72/00);
- Decision on the publication of the third supplement edition of the Anatomic-Therapeutic-Chemical Classification (ATC) of Medicinal Products 2003 (Official Gazette of the Republic of Slovenia, no. 114/03);
- List of indispensable medicinal products for human use (Official Gazette of the RS, nos. 16/04, 38/05 and 81/05);
- Rules determining national formulary addition to the European Pharmacopoeia (Official Gazette of the Republic of Slovenia, no. 86/05);
- Rules on the parallel import and parallel distribution of medicinal products (Official Gazette of the Republic of Slovenia, no. 73/05);
- Decision on the implementation of the European Pharmacopoeia 5th edition (Official Gazette of the Republic of Slovenia, no. 130/04);
- Decision on the implementation of the first, second and third supplement to the European Pharmacopoeia Fifth Edition (Official Gazette of the Republic of Slovenia, no. 31/05);
- Decision designating the official control laboratory for analytical testing of medicinal products for human use (Official Gazette of the Republic of Slovenia no. 51/04);
- Decision specifying the list of inter-exchangeable medicinal products (Official Gazette of the Republic of Slovenia, nos. 6/05 and 17/05);
- Rules on the authorisation for trade in veterinary medicinal products (Official Gazette of the Republic of Slovenia nos. 3/03 and 16/04);
- Rules on the conditions for the wholesale trade in the veterinary medicinal products (Official Gazette of the Republic of Slovenia nos. 75/00 and 1/04);
- Rules on the identification and use instructions of veterinary medicinal products (Official Gazette of the Republic of Slovenia nos. 86/00, 104/00, 86/01 and 4/02);
- Rules on the pharmacovigilance of veterinary medicinal products (Official Gazette of the Republic of Slovenia, no. 70/03);
- Rules on the retailers specialised in veterinary medicinal products (Official Gazette of the Republic of Slovenia no. 55/03);
- Rules determining good manufacturing practice for veterinary medicinal products (Official Gazette of the Republic of Slovenia, no. 75/05);
- Rules on the detailed conditions to be met by the manufacturer of medicinal products for veterinary use and on the procedure for the verification of the manufacturer (Official Gazette of the Republic of Slovenia, no. 28/04);
- Rules on electro-medicinal equipment for use in veterinary medicine (Official Gazette of the Republic of Slovenia, no. 28/04);
- Rules on conditions to be met by experts issuing expert opinions on veterinary medicinal products (Official Gazette of the Republic of Slovenia, no. 28/04);
- Rules on the nature, extent and method of the analytical, pharmacotoxicological and clinical testing of veterinary medicinal products (Official Gazette of the Republic of Slovenia, no. 28/04);
- Rules on the level of expenses for testing of medicinal products, granting of authorisation for the trade in veterinary medicinal products, and for expert supervision (Official Gazette of the Republic of Slovenia no. 28/04);
- Rules on the pharmacovigilance of veterinary medicinal products (Official Gazette of the Republic of Slovenia, no. 67/01);
- Rules on the committee for medicinal products to be used in veterinary medicine (Official Gazette of the Republic of Slovenia, no. 69/2000);
- Rules on the conditions to be met by analysts in analytical testing of veterinary medicinal products and procedure for the verification of these conditions (Official Gazette of the Republic of Slovenia, nos. 1/01 and 13/01);
- Rules on the classification, prescription and administering of veterinary medicinal products (Official Gazette of the Republic of Slovenia, no. 86/00);
- Rules on the exceptional use of medicinal products for the treatment of animals and on animal treatment records (Official Gazette of the Republic of Slovenia, no. 77/00);
- Rules banning the use of certain substances having a hormonal or thyrostatic action and beta-agonists in stock farming (Official Gazette of the Republic of Slovenia, no. 16/04).
(3) With the enforcement of this Act, the Resolution on determining good practices (Official Gazette of the Republic of Slovenia nos. 41/97) shall cease to be valid.
Article 122
(Procedures following the enforcement of this Act)
(1) All ongoing procedures until the implementation of this Act, or, in relation to which a claim or a legal remedy has been filed at the time of the entry into effect of this Act, shall be terminated according to the provisions of the Medicinal Products and Medicinal Devices Act (Official Gazette of the Republic of Slovenia nos. 101/99, 70/00, 7/02, 13/02 – ZKrmi, 67/02 and 47/04 – ZdZPZ), and the implementing regulations issued on the basis of this Act, unless the provisions of this Act are more favourable for the client.
(2) Notwithstanding the provisions of the previous paragraph, the authority competent for medicinal products may request from the applicant who filed the application prior to the enforcement of this Act and until the end of the procedure to submit additional or different documentation or comply with additional evidence in accordance herewith, should this be necessary for the protection of public health.
(3) The provisions on the periods of protection provided for in the first and the second paragraphs of Article 25 hereof shall not apply to reference medicinal products for which an application for authorisation has been submitted before the enforcement hereof.
(4) The provision of the fourth paragraph of Article 72 hereof shall apply for those medicinal products which obtained the marketing authorisation prior to the enforcement hereof no later than within five years after the enforcement hereof.
Article 123
(Updating of documentation)
By no later than 31 December 2007, the marketing authorisation holders who obtained such authorisations before the enforcement of the Medicinal Products and Medicinal Devices Act (Official Gazette of the Republic of Slovenia nos. 101/99, 70/00, 7/02, 13/02 – ZKrmi, 67/02 and 47/04 – ZdZPZ), and the regulations issued on the basis of this Act must submit the data and documentation referred to in Articles 23 and 25 hereof, if such data and documentation have not yet been submitted in the previous procedures related to the marketing authorisation.
Article 124
(Repealed provisions)
(1) On the day this Act enters into force, the Medicinal Products and Medicinal Devices Act (Official Gazette of the Republic of Slovenia nos. 101/99, 70/00, 7/02, 13/02 – ZKrmi, 67/02 and 47/04 – ZdZPZ), shall cease to be valid in the parts relating to medicinal products, namely:
- The entire: Articles 3, 5 to including 28, 113, 119 and 124,
- The parts relating to the prices of medicinal products and dietetic products used for the treatment of metabolic disorders: Article 126,
- In the part relating to medicinal products: Articles 1, 2, 4, 114, 117 and 118.
(2) On the day this Act enters into force, the title of the Medicinal Products and Medicinal Devices Act (Official Gazette of the Republic of Slovenia nos. 101/99, 70/00, 7/02, 13/02 – ZKrmi, 67/02 and 47/04 – ZdZPZ), shall be changed, namely, the words “medicinal products and” will be stricken out.
(3) The marketing authorisations for wholesaling medicinal products, relating to the imports of medicinal products, shall cease to be valid as of the day of enforcement of this Act.
Article 125
(Enforcement of the Act)
This Act shall enter into force on the fifteenth day after its publication in the Official Gazette of the Republic of Slovenia.

No. 520-02/99-3/17
Ljubljana, 7 March 2006
EPA 564-IV
Speaker of the National Assembly of the Republic of Slovenia France Cukjati, MD