R U L E S
on detailed conditions of wholesale of medicinal products and determining of fulfilment of these conditions and procedure of gain the permission for traffic of wholesale of medicinal products

I. GENERAL PROVISIONS
Article 1
(Scope of application)
These Rules lay down the detailed conditions regarding personnel, premises, equipment and document keeping that have to be met, besides the general conditions defined by the act regulating trade, by the legal entities and natural persons wholesaling medicinal products for human use on the territory of the Republic of Slovenia (hereinafter: the medicinal products), the procedure of issuing the authorisation for performing this activity and inspection control over the fulfilment of terms and conditions for wholesaling medicinal products in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 5 June 2001 on the Community code relating to medicinal products for human use (OJ L no. 311 of 28 November 2001, p. 67) as amended by Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008 on the amendment of Directive 2001/83/EC on the Community code related to medicinal products for human use (OJ L no. 81 of 20 March 2008, p. 51) (hereinafter: Directive 2001/83/EC) and Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for veterinary use (OJ L no. 311 of 28 November 2001, p. 1) as amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 on the amendment of Directive 2001/82/EC on the Community code related to medicinal products for veterinary use (OJ L no. 136 of 30 April 2004, p. 58) (hereinafter: Directive 2001/82/EC).

Article 2
(Definitions and expressions)
In addition to the definitions and expressions laid down in Articles 5 and 6 of the Medicinal Products Act (Official Gazette of the RS, no 31/06 and 45/08; hereinafter referred to as: the Act), the following expressions shall also be used in these Rules.
1. The authority competent for medicinal products shall be the Public Agency of the for Medicinal Products and Medical Devices. Republic of Slovenia
2. Good storage practices (DSP) shall be part of the quality system governing the organisation, implementation and control of product storage with the aim of preserving the quality of medicinal products.
3. Recall shall be any recall of medicinal product or a batch of medicinal product. It shall mean any activity aimed at recalling a medicinal product from the market and taking it out of use for inappropriate quality of medicinal product or pharmacovigilance reasons. Recall of a medicinal product can also be partial, which means that it can be carried out only with certain wholesalers and users of medicinal products or that only a certain batch of a medicinal product is recalled.
4. Useful life shall be a time period in which the medicinal product is expected to be in compliance with the specification, subject to adequate storage, as established by the studies on stability performed on several batches of medicinal product.
5. Batch shall be a certain quantity of medicinal product produced from the same components in the scope of one process or a series of processes in a certain period.
6. Batch number shall be a distinctive combination of numbers and letters which define the batch in a unique way, for example on labels, batch documentation and adequate analysis certificates.
7. Validation shall be a documented procedure of testing and certifying that a substance, procedure, method, system or equipment achieves and will continue to achieve certain results.
8. Distribution of medicinal products shall be a procedure of organised distribution and movement of medicinal products from the premises where they had been manufactured or from the manufacturer, directly or indirectly, through other legal entities or natural persons, to the buyer, their end user or to an interim takeover location with different means of transportation, directly to the buyer or indirectly through other legal entities or natural persons.

Article 3
(Wholesale)
(1) 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 and veterinary activity.
(2) Wholesaling of medicinal products may be carried out by legal entities or natural persons meeting the prescribed requirements and holding a marketing authorisation issued by the competent authority for wholesaling of medicinal products (hereinafter: wholesalers).
(3) A wholesaler must obtain the authorisation from the authority competent for marketing medicinal products also for the activity of manufacturing medicinal products, if they intend to manufacture or import medicinal products.
(4) Wholesalers may only buy medicinal products from legal entities and natural persons holding appropriate manufacturing or wholesale marketing authorisation or other adequate authorisations.
(5) Wholesalers may only sell medicinal products to legal entities and natural persons holding appropriate retail or wholesale marketing authorisation and pharmacies, and in the case of selling medicinal products outside the territory of the Republic of Slovenia also other adequate authorisations in accordance with the legislation applicable in the relevant countries.
(6) Wholesalers may also sell medicinal products directly to health institutions or legal entities and natural persons with the authorisation of the competent authority to perform medical activity, and medicinal products for the use in veterinary medicine and medicinal products for the use in human medicine intended for veterinary medicine and other organisations under the terms and conditions stipulated by law and in implementing regulations.
(7) Wholesalers shall be obliged to enable the competent authorities for medicinal products to verify the fulfilment of all the requirements stated herein at any time.
(8) In order to protect the health of human beings, wholesalers must permanently guarantee 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.

Article 4
(Subject of activity)
(1) Wholesales are authorised to wholesale medicinal products.
(2) The wholesalers may only sell medicinal products to the holders of adequate authorisations in the Republic of Slovenia subject to adequate authorisation from Article 17 of the Act.

Article 5
(Classification of medicinal products according to the regime and storage conditions)
(1) In terms of special storage regime, medicinal products shall be classified into the following groups:
- prohibited drugs of groups I and II;
- flammable and dangerous substances;
- medical gases;
- radiopharmaceuticals;
- plant substances.
(2) In terms of storage conditions, medicinal products shall be classified into the following two groups:
- medicinal products stored in usual conditions;
- medicinal products stored in special conditions (e.g. “cold chain”).

II. PRINCIPLES AND GUIDELINES OF GOOD DISTRIBUTION PRACTICE
Article 6
(Quality assurance system)
Wholesalers must set up, implement and update an efficient quality assurance system for all activities related to the performance of their activity in such a way that the management and the personnel of internal organisational units participate in the quality assurance system.

Article 7
(Personnel)
(1) In terms of personnel, wholesalers must meet the following terms and conditions:
- have at their disposal the services of professionals, based on contractual relationship, holding a university degree in pharmacy or, depending on the nature of the work process, contractually bound experts in other disciplines;
- have appointed 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.
(2) If the responsible person stipulated in the second indent 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) The wholesaler is obliged to provide permanent training and education for the personnel and particularly the responsible person.

Article 8
(Premises and equipment)
When performing their activity, wholesalers must have available adequate premises and equipment in line with the principles of good distribution practice and the principles of good storage practice.

Article 9
(Documentation)
(1) Wholesalers must set up, manage and update written procedures relating to the entire distribution process and keep records on the provision of the terms and conditions for the distribution of medicinal products (calibration, equipment qualification, validation, cleaning and maintenance of premises, etc.).
(2) Wholesalers must keep appropriate documentation and records referred to in the previous paragraph so as to enable immediate recall of a medicinal product from the market and to monitor complaints. Each individual handling of a medicinal product must be recorded so as to ensure traceability of such product.
(3) The documentation referred to in the previous paragraph must comprise at least:
- date of received or issued medicinal product;
- name, pharmaceutical form, strength and packaging of medicinal product;
- batch number and expiry date of medicinal product;
- quantity of received or issued medicinal product;
– name and address of the manufacturer of the medicinal product;
- results of quality analysis and date of release of each batch of medicinal product;
– name and address of the supplier of the medicinal product;
– name and address of the recipient of the medicinal product;
– name and address of the company in charge of transporting the medicinal product.
(4) The wholesaler shall be obliged to keep the documents referred to under the previous paragraph for at least one year after the expiry date of the medicinal product or after the withdrawal of such medicinal product from the market or longer, if required by the prescribed principles of good distribution practices.
(5) The wholesalers of medicinal products for the use in veterinary medicine and medicinal products for the use in human medicine for exceptional use in veterinary medicine must submit quarterly reports to the Veterinary Administration of the Republic of Slovenia.
(6) The reports referred to in the previous paragraph must comprise at least:
- the amount of issued medicinal products for each medicinal product;
- individual recipient, indicating the data for the period to which the report refers;
- indication of the responsible person for medicinal products.
Reports must be submitted in the standardised form determined by the Veterinary Administration of the Republic of Slovenia.
(7) The wholesaler must set up, verify and update written procedures in accordance with the provisions of good distribution practice.

Article 10
(The guidelines of good manufacturing practice)
The wholesaler must take into account the guidelines of good distribution practice.

III. PROCEDURE FOR OBTAINING THE AUTHORISATION
Article 11
(Application)
(1) The procedure for obtaining the authorisation for wholesaling medicinal products (hereinafter: authorisation) begins with the application to obtain the authorisation, which is submitted by the applicant to the authority competent for medicinal products either on paper or in electronic form.
(2) The application referred to in the previous paragraph shall contain the following data and documents:
- a short description of the applicant and activities they intend to carry out (imports, exports, entry, exit, purchase, sale, storage, distribution, quality control);
- list of the classes of medicinal products according to the special regime and storage conditions;
- statement of the activity of wholesaling medicinal products in terms of trading in:
- risk medicinal products;
- other medicinal products;
- active ingredients;
- systemisation and job occupation in accordance with these Rules;
- contract with the responsible person and other persons from Article 7 hereof in the scope proving employment;
evidence on available business premises, description of business premises and a draft ground plan in adequate scale, corresponding to the actual dimensions of the premises;
- evidence on available equipment and technical data on such equipment;
- list of written instructions with a description of standard operating procedures on the implementation of good distribution practice, good storage practice, good transportation practice and good laboratory control practice (if control is exercised in own laboratory) and on the procedure of recalling medicinal products from marketing and destroying them;
- a written statement of the applicant that they would provide for taking over and further handling in accordance with the provisions regulating waste medicinal products;
- in the case of imports of medicinal products, a contract with a legal entity or natural person with authorisation issued by the authority competent for medicinal products for analytical testing of medicinal products, if quality controls are not performed in own laboratory;
- the evidence that the costs of procedure have been paid;
- the evidence that the prescribed administrative tax has been paid for the application and the issue of the decision.

Article 12
(Supplementing the application)
If the authority competent for medicinal products finds out that the application referred to in the previous paragraph is incomplete, it shall request the application be supplemented and determine the deadline for supplementing the application.

Article 13
(Verification of the fulfilment of prescribed terms and conditions)
(1) Following the establishment by the officials of the authority competent for medicinal products that the application from Article 11 of these Rules is formally complete, the authority competent for medicinal products issues a resolution on the appointment of a committee, consisting of at least two members, to verify that the terms and conditions have been met, which shall conduct an examination at the applicant and determine the deadline for the examination.
(2) Verification minutes are recorded and signed by all members of the committee and the person who proposed the procedure. The committee shall issue a written opinion on the fulfilment of conditions within fifteen days of verification. The minutes of such verification shall be part of the opinion.

Article 14
(Issue of authorisation)
(1) Based on a written opinion of the committee from the previous Article, the authority competent for medicinal products decides on the issue of authorisation within 90 days after receiving a complete application from Article 11 hereof. The marketing authorisation for wholesaling of medicinal products shall be issued separately by group of medicinal product from Article 5 hereof and type of activity from Article 3 hereof.
(2) Any time during the process of issuing the marketing authorisation for wholesaling of medicinal products the competent authority may demand that the applicant submit additional explanations or documents and lay down a new deadline for responding or eliminating deficiencies. Such additional deadline shall not be part of the 90-day deadline for issuing the decision.

IV. THE PROCEDURE RELATED TO THE CHANGE IN CONDITIONS WHICH SERVED AS THE BASIS FOR THE ISSUE OF AUTHORISATION
Article 15
(Change of terms and conditions)
(1) Authorisation holder must inform in writing the authority competent for medicinal products of any change to the terms and conditions which served as the basis for the issue of the marketing authorisation for wholesaling medicinal products, immediately and in no case later than within 15 days from the occurrence of the change, and submit the relevant data and documents from Article 11 hereof, which relate to this change.
(2) Based on the type of notified amendment on the price, the Pharmaceutical Inspection shall assess if the terms and conditions for performing the activity of wholesale of medicinal products need to be verified again and carry out the procedure from Article 13 hereof.
(3) If the authority competent for medicinal products assesses that no special verification procedure is needed, it shall adopt a decision on the notified change within 30 days of receiving a complete application.

V. INSPECTION
Article 16
(Type of inspection)
(1) In accordance with the applicable law, the Pharmaceutical Inspection shall carry out regular and extraordinary expert inspections of the wholesale marketing authorisation holders.
(2) The Pharmaceutical Inspection shall carry out the regular professional inspection ex officio every 2 or 3 years. Should the competent authority establish any incompliance with the abovementioned conditions or significantly changed circumstances, it shall have the right to issue a new decision on eliminating, annulling or amending the previous decision.
(3) The Pharmaceutical Inspection shall carry out the extraordinary professional inspection in case it finds a violation or if there is grounded suspicion of violation of the provisions of good distribution practice.

VI. THE PROCEDURE OF NOTIFYING THE ACTIVITY OF WHOLESALING MEDICINAL PRODUCTS IN THE REPUBLIC OF SLOVENIA
Article 17
(Application)
(1) Legal entities or natural persons having obtained the marketing authorisation for wholesaling of medicinal products in any EU Member State and intending to wholesale medicinal products in the Republic of Slovenia must notify the competent authority of the Republic of Slovenia before they can start with the wholesaling of medicinal products in the Republic of Slovenia.
(2) The notification application must include:
- an accompanying letter with a short presentation of the applicant;
- a valid marketing authorisation for wholesaling of medicinal products;
- a statement of activities from Article 3 hereof, planned to be carried out in the Republic of Slovenia;
- a statement of the groups of medicinal products from Article 5 hereof that are to be wholesaled in the Republic of Slovenia;
- a statement of locations of warehouses storing medicinal products;
- a description of distribution route and area of operations;
- a contact person for 24-hour availability;
- a written statement of the applicant that they would provide for taking over and further handling in accordance with the provisions regulating waste medicinal products.
(3) The application specified in the previous paragraph shall be submitted in paper or electronic form.
(4) If the authority competent for medicinal products finds out that the application referred to in the second paragraph of this Article is incomplete, it shall request the application be supplemented and determine the deadline for supplementing the application.
(5) The deadline for the issue of certificate by means of which a legal entity or a natural person is entered into the official record of legal entities and natural persons who have obtained the marketing authorisation for wholesaling of medicinal products in an EU Member State and have notified themselves to the authority competent for medicinal products in the Republic of Slovenia shall be 90 days from the complete application.
(6) Before the issue of certificate by means of which a legal entity or a natural person is entered into the official record of legal entities and natural persons who have obtained the marketing authorisation for wholesaling of medicinal products in an EU Member State and have notified themselves to the authority competent for medicinal products in the Republic of Slovenia shall be 90 days from the complete application, the authority competent for medicinal products may, even if the application is complete, demand that the applicant submit additional explanations or documents and lay down a new deadline for responding. Such additional deadline shall not be part of the 90-day deadline for issuing the certificate.

VII. TRANSITIONAL AND FINAL PROVISIONS
Article 18
(Harmonisation)
The holders of authorisations for wholesaling medicinal products must align their organisation and operation with these rules within three months after the implementation.

Article 19
(Termination of application)
The Rules on detailed conditions of wholesale of medicinal products (Official Gazette of the RS, no. 75/03) and the Rules on the conditions for the wholesale trade in the veterinary medicinal products (Official Gazette of the Republic of Slovenia, nos. 75/00 in 1/04) shall cease to apply on the date these Rules enter into force.

Article 20
(Entry into force)
These Rules shall enter into force on the fifteenth day after their publication in the Official Gazette of the Republic of Slovenia.