R U L E S
on the classification, prescribing and dispensing of medicinal products for human use

I. GENERAL PROVISIONS
Article 1
(scope of application)
Pursuant to Directive 2001/83/EC of the European Parliament and of the Council of 5 June 2001 on the Community code related 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) these Rules specify the determination, method of classification based on prescribing and dispensing medicinal products, method of prescribing and method of dispensing medicinal products for human use.
Article 2
(definition of terms)
In addition to the definitions and expressions delineated 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 and shall have the following meaning:
1. Medical prescription shall mean a public document by means of which an expert qualified and authorised to prescribe medicinal products prescribes a medicinal product which is dispensed by an authorised person in a pharmacy. A medical prescription is a prescription or an order form.
2. Prescription is a type of medical prescription on an officially valid prescription form in paper or electronic format, on which an expert qualified and authorised to prescribe medicinal products prescribes a medicinal product which is dispensed by an authorised person in a pharmacy for an individual user.
3. Officially valid prescription form is the prescription form issued by the authorised institution in the Republic of Slovenia. A form of medical prescription determined by the applicable general provisions of another country shall also be deemed a valid prescription form.
4. Order form for medicinal products is a type of medical prescription on which the expert qualified and authorised to prescribe medicinal products, in a public health institute or with a legal entity or natural person performing medical activity, prescribes medicinal products for performing its activity which are dispensed by an authorised person in a pharmacy.
5. Delivery document for medicinal products is a document issued by the authorised person in the pharmacy upon dispensing medicinal products on the basis of the order form.
6. Non-renewable prescription is a prescription that can only be used once for obtaining medicinal products.
7. Renewable prescription is a prescription that can be used several times for obtaining medicinal products.
8. Special medical prescription is a special prescription or a special order form.
9. Special prescription is a prescription in two identical copies with the mark “copy” on the second one. Both copies of a special medical prescription must contain a serial number from the officially sealed book of records on issued medical prescriptions kept by the persons issuing prescriptions and the serial number from the officially sealed book of records on issued medicinal products, kept by the pharmacies.
10. Special order form for medicinal products is an order form in two identical copies with the mark “copy” on the second one. Both copies of a special medical prescription must contain a serial number for each medicinal product from the officially sealed book of records on issued medical prescriptions kept by the persons issuing prescriptions and the serial number from the officially sealed book of records on issued medicinal products, kept by the pharmacies.
11. Special delivery document for medicinal products is a delivery document in two identical copies with the mark “copy” on the second one. Special delivery document must contain a serial number for each medicinal product from the officially sealed book of records on issued medical prescriptions kept by the persons issuing prescriptions and the serial number from the officially sealed book of records on issued medicinal products, kept by the pharmacies.
12. Medicinal product on restricted medical prescription and dispensing is a medicinal product dispensed on a medical prescription, reserved for use in certain specialized areas.
13. Pharmacy is a pharmacy unit of a public health institute, pharmacy, pharmacy subsidiary and hospital pharmacy in accordance with the provisions regulating the practice of pharmacy.
14. List of interchangeable medicinal products is a list of medicinal products specified by the body competent for medicinal products and published in the Official Gazette of the Republic of Slovenia as suitable to be interchanged.
Article 3
(authorised institutions)
(1) Authorised institution in the Republic of Slovenia for the issue of officially valid prescription forms on which medicinal products are prescribed for which costs are fully or partially covered from the compulsory health insurance is the Health Insurance Institute of Slovenia.
(2) Authorised institution in the Republic of Slovenia for the issue of officially valid prescription forms on which medicinal products are prescribed for which costs are not covered from the compulsory health insurance is the Institute of Public Health of the Republic of Slovenia.
(3) Authorised institution for official sealing of the books of records is the body competent for medicinal products.
Article 4
(personal data protection)
Persons authorised to prescribe and issue medicinal products and other persons having access to data on medical prescription or data on the user of a medicinal product, shall be obliged to protect the data on the users of medicinal products in line with the provisions regulating personal data protection.
II. DETERMINATION AND METHOD OF CLASSIFYING MEDICINAL PRODUCTS
Article 5
(classification of medicinal products)
(1) In terms of prescribing practices, medicinal products shall be determined and classified as follows:
- medicinal products for which medical prescription is required;
- medicinal products for which medical prescription is not required.
(2) Medicinal products for which medical prescription is required shall only be dispensed in pharmacies.
(3) Medicinal products for which medical prescription is not required shall be classified, based of the dispensing point, into:
- medicinal products dispensed over-the-counter in pharmacies only;
- medicinal products dispensed over the counter in pharmacies and specialised shops.
Article 6
(criteria for classifying medicinal products on medical prescription)
Medicinal products dispensed on the basis of medical prescription shall include medicinal products that meet at least one of the following criteria:
1. Are likely to present a danger for the user either directly or indirectly, even when used correctly, if utilized without medical supervision;
2. Are frequently and to a very wide extent used incorrectly, and as a result are likely to present direct or indirect threat to human health;
3. contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation;
4. Are used in pharmaceutical forms for parenteral use.
Article 7
(sub-groups of medicinal products on medical prescription)
Medicinal products for which medical prescription is required may also be classified into sub-groups, namely:
- medicinal products prescribed and dispensed on renewable or non-renewable medical prescription;
- medicinal products prescribed and dispensed on special medical prescription;
– medicinal products on restricted medical prescription and dispensing;
Article 8
(renewable prescription)
Medicinal products prescribed and dispensed on renewable medical prescription include medicinal products used for long-term administration or treatment of chronic or repeating disorders or diseases and do not meet the criteria from Articles 9 and 10 hereof. Medicinal products containing psychotropic substances from group IIIb of the Production of and Trade in Illicit Drugs Act (Official Gazette of the Republic of Slovenia nos. 108/99, 44/00, 2/04 – ZZdrI-A and 47/04 – ZdZPZ) may not be prescribed on renewable prescription.
Article 9
(special medical prescription)
(1) Medicinal products prescribed and dispensed on special medical prescription shall include medicinal products containing narcotic and psychotropic substances from groups II, IIIa and IIIc of the Production of and Trade in Illicit Drugs Act.
(2) Medicinal products issued on special medical prescription include medicinal products that contain a substance or active substance that is new or has special features due to which classification in such sub-group is a precautionary measure.
Article 10
(medicinal products on restricted medical prescription)
(1) Medicinal products on restricted medical prescription and dispensing are classified into the following sub-groups:
– H: medicinal product, because of its characteristics or novelty or in the interests of public health, is reserved for treatments which can only be followed in a hospital environment;
– H/Rp: medicinal product is used in the treatment of conditions which must be diagnosed in a hospital environment or in institutions with adequate diagnostic facilities, although administration and follow-up may be carried out elsewhere;
– Rp/Spec.: medicinal product is intended for outpatients but its use may produce very serious adverse reactions requiring a prescription drawn up as required by a specialist or a general practitioner authorised by such specialist and special supervision throughout the treatment;
– ZZ: due to the method of use which requires that the medicinal product be administered or supervised by a health professional, it may only be used in public institutions and by legal and natural persons practicing medicine.
(2) For medicinal products on medical prescription that are not prescribed and dispensed on restricted medical prescription, as specified in the previous paragraph, the abbreviation
Rp is used.
Article 11
(medicinal products without prescription)
(1) Medicinal products dispensed without medical prescription shall include medicinal products that do not meet the criteria from Articles 6, 7, 8, 9 and 10 hereof. More detailed criteria for classification among medicinal products dispensed without prescription are defined in Articles 12 to 17 hereof.
(2) Abbreviation BRp. is used for medicinal products dispensed without medical prescription.
Article 12
(direct threat to the user)
(1) Medicinal products dispensed without medical prescription shall be classified into medicinal products that meet the following criteria regarding direct threat:
- they must have low general toxicity and must not have significant impact on reproductive ability, genotoxic or carcinogenic features;
- they must present low risk for serious adverse reactions;
- they must present very low risk for unexpected serious adverse reactions;
- they may not interact with generally used medicinal products due to which serious adverse reactions could occur.
(2) Contraindications, interactions, warnings and precautions related to a medicinal product dispensed without prescription must be such that users can understand them.
(3) When classified among medicinal products dispensed without medical prescription, the risk for serious adverse reactions is only acceptable if risk target groups of people can be excluded preventively, without medical supervision.
Article 13
(indirect threat to the user)
(1) Medicinal products dispensed without medical prescription shall be classified into medicinal products that meet the following criteria regarding indirect threat:
- They are intended for self-treatment limited to prevention, easing and remedying the syndromes and medical problems which as a rule do not require consultation with a general practitioner and can be correctly chosen by the user. The probability of incorrect identification of an illness and untimely treatment must be reduced to the minimum. Therefore, medicinal products dispensed without prescription are only intended for short-term periods of self-treatment;
- They must not be intended for remedying symptoms that could be typical for various illnesses, so that a user is not able to distinguish between these illnesses.
(2) Medicinal products dispensed without prescription must have such information leaflets enclosed and must be marked in such a way that they guarantee safe self-treatment. The information leaflets must contain sufficient data and must be clear enough for the user so that they can be used as an alternative to visiting a general practitioner.
Article 14
(incorrect use of medicinal product)
(1) In the case of medicinal products dispensed without medical prescription, the threat to health must be minimal, also in the following cases:
- they are used even when not indicated,
- they are used for a longer period than recommended,
- the recommended doses have been exceeded, or
- they have been used without taking into account the warnings and contraindications.
(2) Medicinal products dispensed without medical prescription may not include medicinal products the use of which could lead to addiction.
(3) Medicinal products dispensed without medical prescription may not present the risk for the development of resistance to such medicinal product due to extensive use.
Article 15
(insufficient experience with the medicinal product)
(1) A medicinal product that is relatively new on the market or is used less frequently and for which there is not much experience may not be classified among medicinal products dispensed without medical prescription.
(2) There must be enough data on the safety of medicinal products dispensed without medical prescription for the general population, without excluding certain groups of users, unless special warnings are indicated for such groups.
Article 16
(changes to or expansion of marketing authorization)
If new strengths, new method of use, new indications, use in new age groups, new combinations of active substances are proposed for a medicinal product dispensed without prescription, the safety/risk ratio must be reassessed for each such change to establish if the proposed change is suitable for the medicinal product dispensed without prescription.
Article 17
(other conditions for medicinal products without prescription)
(1) If a medicinal product corresponds to any criterion from Article 6 hereof for classification among medicinal products dispensed on medical prescription, it may be classified among medicinal products dispensed without medical prescription under condition that the highest single dose, the highest daily dose, strength, pharmaceutical form, packaging and other circumstances correspond to the criteria for classification among medicinal products dispensed without prescription only in pharmacies.
(2) A medicinal product dispensed without prescription must be packed in adequately small packaging and in appropriate container. Adequate proof must exist that the efficiency of a medicinal product is maintained even if the dose is reduced.
Article 18
(medicinal products dispensed over-the-counter, i.e. without prescription in pharmacies only)
Medicinal products dispensed without prescription only in pharmacies contain active substances of synthetic, semi-synthetic, bio-synthetic or natural origin and inorganic active substances for which the body competent for medicinal products establishes that supervision and advising in pharmacies is required to ensure safe self-treatment. It takes into account the contraindications, the necessary warnings and precautions, the possibility of interaction with other medicinal products and the possibility of occurrence of adverse reactions, misinterpretation of illnesses and possible consequences due to untimely treatment, possible overdose and abuse of medicinal product and the possibility of development of resistance of micro-organisms to medicinal products.
Article 19
(medicinal products dispensed over-the-counter, i.e. without prescription in pharmacies and specialised shops)
(1) Medicinal products dispensed without prescription in pharmacies and specialised shops contain active substances of natural origin and inorganic active substances, rarely also of synthetic, semi-synthetic, bio-synthetic origin.
(2) Medicinal products dispensed in pharmacies and specialised shops without prescription shall have moderate strength of pharmacokinetic effects. They are used for remedying minor symptoms and health problems. They are relatively harmless, as established by the body competent for medicinal products.
Article 20
(scope of application of medicinal products dispensed over-the-counter, i.e. without prescription in pharmacies and specialised shops)
Medicinal products dispensed in pharmacies and specialised shops without prescription are medicinal products for:
1. Easing pain in pharmaceutical forms for external use;
2. Easing rheumatic problems in pharmaceutical forms for external use;
3. Stimulating expectoration;
4. Easing cough;
5. Disinfection of oral cavity, skin and mucous membrane;
6. Easing pain due to runny nose and cold;
7. Improving vitality and immune system;
8. Easing pain due to urethra inflammation;
9. Improvement and regulation of digestion;
10. Easing skin and mucous membrane inflammations (including antihemoroidaliae);
11. Easing pain in the menstrual cycle or in the menopause period;
12. Easing pain due to peripheral circulatory disturbances;
13. Easing stomach pain and disturbances;
14. Treating and preventing habits that are harmful to health;
15. Reducing weight;
16. Other indications determined by the authority responsible for medicinal products.
Article 21
(criteria for classifying products among medicinal 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 the Act shall apply in the case of doubt.
(2) The body competent for medicinal products shall determine such products, taking into account above all the following criteria:
- Qualitative and quantitative composition of the product;
- Does the product or its components have pharmacological effects;
- Does the product have direct or indirect healing effects;
- Presentation of the product and impression the product makes on the consumer;
- Possible adverse reactions and related risks due to prolonged use of the product;
- Familiarity of consumers with the product;
- The latest scientific findings.
III. PRESCRIBING MEDICINAL PRODUCTS
Article 22
(prescribing medicinal products)
(1) Persons authorised to prescribe medicinal products on medical prescription for human use shall be licensed general practitioners based on the law regulating general practitioners service, who may only prescribe medicinal products marketed in accordance with the applicable act.
(2) Medicinal products specified in the previous paragraph shall be prescribed with medical prescription.
(3) In prescribing medicinal prescriptions in electronic form, the provisions of these Rules as well as the provisions on electronic operations need to be taken into account.
Article 23
(structure of medical prescription)
(1) A medical prescription consists of administrative and expert sections.
(2) The administrative section of the prescription contains data on the user of the medicinal product, on the general practitioner, on the payer and other required data.
(3) The expert section contains the order issued by the medical practitioner to the authorised person on which medicinal product to dispense, the dosage and method of administration of the medicinal product concerned for the specific user.
(4) The authorisation of the authorised person for prescribing medicinal products for human use includes the filling in of the administrative and the expert section of the prescription.
(5) The prescription must be written or printed in a legible and indelible manner.
(6) Only one medicinal product for one person may be prescribed on one prescription form.
Article 24
(data on the prescription form)
The prescription must include at least the following data:
1. Proprietary or common name of medicinal product;
2. Pharmaceutical form and strength of medicinal product;
3. Quantity of medicinal product which is, as a rule, expressed with the number of original packages with specified number of units and can exceptionally be expressed also with the number of dosage units or the number of days of treatment;
4. Posology and method of administration of medicinal product;
5. Personal number of medical practitioner;
6. Signature with personal stamp and telephone number of medical practitioner;
7. Stamp with name and address of the public health institution or legal or natural person practicing medical activity, where the prescription was issued, with the exception of prescription forms from Article 210 of the Compulsory health insurance rules (Official Gazette of the Republic of Slovenia nos. 30/03 – consolidated text, 35/03 – amen., 78/03, 84/04, 44/05, 86/06, 90/06 – amen., 64/07 and 33/08) and prescription forms for dispensing medicinal products not paid from the compulsory health insurance;
8. Date of prescription;
9. Name, last name and address of the user of medicinal product;
10. Month and day of birth and sex of the user of medicinal product;
11. Other information required by other relevant provisions.
Article 25
(additional elements of the prescription)
Compulsory health insurance provider may determine the form and additional elements of a prescription form in accordance with the applicable provisions and its internal regulations, besides those prescribed herein, namely for medicinal products issued on prescription which are paid from compulsory health insurance.
Article 26
(names of medicinal products on the prescription form)
(1) Proprietary and common names of medicinal products and names of active ingredients may not be abbreviated.
(2) As a rule, names of magistral formulae ingredients are written in Latin, using the names from the applicable pharmacopoeias or other official and expert provisions.
Article 27
(general practitioner’s instructions for the use of medicinal product)
(1) A general practitioner must provide adequate information on the prescribed medicinal product to the user, including the possibility of replacements from the list of interchangeable medicinal products and potential extra charges.
(2) The prescription must clearly and completely state the instruction on posology and method of administering the medicinal product. The phrase “as instructed” is not sufficient, unless referring to written instructions given to the user.
(3) If a medicinal product is only prescribed for temporary use (as required), the largest daily dose of medicinal product for a specific user must be stated.
(4) The instruction on a medical prescription for a medicinal product to be administered by a health professional must be marked with “ad manum medici”.
Article 28
(statement of the units of measurement on the prescription form)
(1) If the mass of a medicinal product must be measured when preparing such medicinal product, the general practitioner must specify on the prescription the appropriate unit of measurement pursuant to the international system of units (SI) in Arabic numerals, at least to one decimal place accurately.
(2) Notwithstanding the provision of the previous paragraph, the unit of measurement need not be specified if the mass of the medicinal product is measured in grams (g).
(3) If drops are to be measured when preparing a medicinal product, the general practitioner must specify their number with Roman numerals and also in words in brackets.
Article 29
(specification of the amount of medicinal product on the prescription form)
(1) The general practitioner must mark the number of packages with Roman numerals. Their number must also be specified in words in brackets.
(2) If the quantity of medicinal product is determined in the number of treatment days, such number must also be written in words.
Article 30
(statement of a different manner of posology)
If the general practitioner prescribes a dose that exceeds the maximum dose or another manner of posology as that specified in the marketing authorisation and other regulations, the numbers must also be written in words and an exclamation mark (!) must be added as well as the general practitioner’s signature.
Article 31
(urgent dispensing of medicinal product)
If the nature of the disease is such that a medicinal product must be issued immediately, the general practitioner must write the following words on the prescription: “urgent“, “cito“, “statim“ or “periculum in mora“.
Article 32
(prohibited substitution of the prescribed medicinal product)
If a general practitioner does not wish that another medicinal product be dispensed on the prescription issued, from the list of interchangeable medicinal products, this must be marked with the words “Do not substitute!” and signed. A general practitioner may only prohibit such substitution if it would jeopardise the user’s health or safety.
Article 33
(renewable prescription)
(1) Medicinal products prescribed and dispensed on renewable medical prescription shall include medicinal products for long-term administration or treatment of chronic or repeating disorders or diseases without restrictions to prescribing and dispensing and medicinal products not containing narcotic and psychotropic substances from groups II and III of the Production of and Trade in Illicit Drugs Act.
(2) On such renewable medical prescription, the general practitioner must write “repetatu” or “repeat” if they wish the medicinal product to be dispensed again on the same prescription. The number of required repetitions must be marked with a number and in words.
(3) Renewable prescription shall only be valid for the number of prescribed repetitions or one year at the maximum from the date of prescription.
(4) If the general practitioner does nit specify the number of repetitions next to the mark “repetatu” or “repeat”, the medicinal product shall only be dispensed once more.
(5) Medicinal products paid from compulsory health insurance may only be prescribed on renewable prescription in line with these rules and in accordance with the regulations of the compulsory health insurance provider.
Article 34
(corrections on the prescription)
Only the general practitioner who issued the prescription may make any corrections in the expert section of the medical prescription. Incorrect text must be stricken so that it is still possible to read it. Signature must be added to confirm any corrections made.
Article 35
(prescription validity)
A prescription shall be valid for 30 days of the date of issue unless otherwise specified in these rules, the marketing authorisation or other provisions regulating medicinal products. The said period shall begin on the next day following the issue of prescription.
Article 36
(prescribing medicinal products containing narcotic and psychotropic substances)
Medicinal products containing narcotic and psychotropic substances may only be prescribed if their use is urgent and if the Production of and Trade in Illicit Drugs Act stipulates that they can be sold for medical purposes. They may only be prescribed in line with the accepted national guidelines for treating pains in patients suffering from cancer and chronic pains not resulting from cancer.
Article 37
(medicinal products containing narcotic and psychotropic substances)
(1) Medicinal products from the previous Article are medicinal products containing one or several narcotic and psychotropic substances from groups II and III of the Production of and Trade in Illicit Drugs Act.
(2) The provision laid down in the preceding paragraph does not refer to medicinal products containing the following:
- less than 100 mg of folcodine in a dose or less than 2.5% in indivisible form of medicinal product or
- less than 30 mg of codeine in combination with other active ingredients in a dose or less than 2.5% in indivisible form of medicinal product, calculated based on codeine (base).
Article 38
(limited prescribing of medicinal products containing narcotic and psychotropic substances)
(1) For single dispensing, a general practitioner may prescribe a medicinal product for a single user in quantities for treatment up to 30 days, namely:
- maximum 800 mg buprenorphine;
- maximum 7,500 mg dihydrocodeine;
- maximum 500 mg dronabinol;
- maximum 2,500 mg fenethylline;
- maximum 700 mg fentanyl;
- maximum 1,200 mg hydrocodone;
- maximum 3,200 mg hydromorphone;
- maximum 7,500 mg codeine;
- maximum 3,000 mg racemic methadone;
- maximum 1,500 mg levomethadone;
- maximum 20,000 mg morphine;
- maximum 12,000 mg modafinil;
- maximum 600 mg nalbuphine;
- maximum 40,000 mg opium tincture;
- maximum 13,000 mg oxycodone;
- maximum 15,000 mg pentazocine;
- maximum 10,000 mg pethidine;
- maximum 6,000 mg piritramide.
The specified quantities refer to the amount of medicinal product in the pharmaceutical form.
(2) Per day of treatment, a general practitioner may only prescribe one tenth of the quantities specified in the previous paragraph per individual patient, while the total quantity of a medicinal product prescribed may not exceed the quantity specified in the previous paragraph.
(3) Notwithstanding the first and the second paragraphs hereunder, a general practitioner may only prescribe those medicinal products from the first and the second paragraphs hereunder used in dental medicine, namely for single issue for one user up to one third of the quantity of these medicinal products.
(4) The quantities from the first paragraph hereunder do not apply to the treatment of addiction and if they are prescribed by means of a special order form for the use in health institutes and legal and natural persons practicing medical activity.
(5) Cocaine and medicinal products containing it (cocaine salts and freebases) may not be prescribed or dispensed on prescription.
Article 39
(prescribing medicinal products on special medical prescription)
(1) Medicinal products containing narcotic and psychotropic substances from groups II, IIIa and IIIc of the Production of and Trade in Illicit Drugs Act shall be prescribed on special medical prescription or special order. They may only be prescribed by general practitioners registered in the Republic of Slovenia. These medicinal products may not be prescribed on prescription forms from Article 210 of the Compulsory health insurance rules.
(2) Both copies of a special medical prescription and special order must contain a serial number from the officially sealed book of records on issued medical prescriptions and the word »copy« must be marked on the second copy.
(3) A special medical prescription or special order form shall be valid for five days of the date of prescription, starting on the next day after prescription.
Article 40
(officially sealed books of records on prescribing medicinal products)
(1) General practitioners must keep officially sealed books of records on prescribing medicinal products containing narcotic and psychotropic substances from groups II, IIIa and IIIc of the Production of and Trade in Illicit Drugs Act prescribed on special medical prescription or special order. Book of records must be numbered from the first to the last page and sealed with the seal of the public health institute or legal or natural person practicing medical activity, as well as name(s), surname(s) and personal number(s) of general practitioner(s). Depending on the organisation of public health institute or legal or natural person practicing medical activity, several general practitioners can use the same book of records. General practitioners must keep records of the following data:
1. Serial number;
2. Date of prescription;
3. Prescribed proprietary or common name, pharmaceutical form, strength and packaging of medicinal product and amount of prescribed medicinal product and posology;
4. Name, last name and address of the user of medicinal product;
5. Signature, name, surname and personal number of the general practitioner who issued the prescription. In addition to the prescribed medicinal product, the records may only contain the general practitioner’s signature if the name, surname, personal number and signature of the general practitioner are evident from the introductory part of the book of records.
(2) General practitioners or specified responsible persons in public health institutes or legal and natural persons practicing medical activity must keep officially sealed books of records on the purchase, consumption and stocks of medicinal products containing narcotic and psychotropic substances from groups II, IIIa and IIIc of the Production of and Trade in Illicit Drugs Act for medicinal products used in the scope of practicing medical activity for direct application to the users. The book of records must be kept in such a way that enables traceability.
(3) The books of records specified in this Article must be protected against possible abuse or destruction.
(4) General practitioners must keep the books of records stipulated hereunder for at least five years following the date of the last entry on a medicinal product containing narcotic and psychotropic substances in accordance with the provisions regulating the archived documents.
Article 41
(prescribing medicinal products with H and ZZ dispensing regimes)
(1) Medicinal products on prescription with H prescribing and dispensing regime shall only be prescribed with order forms.
(2) Medicinal products on prescription with ZZ prescribing and dispensing regime shall, as a rule, be prescribed with order forms. Prescription may only be issued exceptionally, if it guarantees the transfer of medicinal product from the pharmacy to the public health institute or legal or natural person practicing medical activity in adequate temperature and other storage conditions.
Article 42
(data on the order form)
(1) The order form must include at least the following data:
1. Proprietary or common name of medicinal product;
2. Pharmaceutical form and strength of medicinal product;
3. Quantity of medicinal product;
4. Signature and personal stamp, possibly also telephone number of medical practitioner;
5. The date of issue of the order form;
6. Printed name and address of public health institute or legal or natural person practicing medical activity, and
7. Other information required by other relevant provisions.
(2) Several medicinal products may be prescribed on a single prescription form.
(2) General practitioners or specified responsible persons in public health institutes or legal and natural persons practicing medical activity must keep officially sealed books of records on issued special orders and received special delivery documents for medicinal products containing narcotic and psychotropic substances from groups II, IIIa and IIIc of the Production of and Trade in Illicit Drugs Act in a manner that enables traceability.
(4) The books of records specified in the previous paragraph must be protected against possible abuse or destruction.
(5) General practitioners must keep the books of records stipulated in the third paragraph hereunder for at least five years following the date of the last entry on a medicinal product containing narcotic and psychotropic substances in accordance with the provisions regulating the archived documents.
IV. DISPENSING OF MEDICINAL PRODUCTS
Article 43
(persons authorised to dispense medicinal products)
(1) Medicinal products may only be dispensed by authorised persons.
(2) Person authorised to dispense medicinal products on special prescription and special order form shall be a Master of Pharmacy who has passed the qualifying examination.
(3) Person authorised to dispense medicinal products on renewable prescription shall be a Master of Pharmacy who has passed the qualifying examination.
(4) Person authorised to dispense medicinal products on medical prescription shall be a Master of Pharmacy and a Pharmacy Engineer who has passed the qualifying examination.
(5) Person authorised to dispense medicinal products dispensed without medical prescription only in pharmacies shall be a Master of Pharmacy and a Pharmacy Engineer who has passed the qualifying examination, as well as a pharmacy technician who has passed the qualifying examination, under the supervision of a Master of Pharmacy.
(6) Person authorised to dispense medicinal products without prescription in specialised stores shall be, in addition to persons specified in the previous paragraph, a pharmacy technician who has passed the qualifying examination.
Article 44
(dispensing of medicinal products)
(1) Authorised person in pharmacy must dispense a medicinal product in accordance with these Rules.
(2) All medicinal products prescribed on medical prescription may only be issued in pharmacies.
(3) Upon dispensing a medicinal product, the prescription shall be kept by the pharmacy.
Article 45
(dispensing medicinal products in original packaging)
Medicinal products for individual use may only be dispensed in original packaging.
Article 46
(verification of data upon dispensing medicinal products)
(1) When dispensing a medicinal product, an authorised person may demand the user of the medicinal product to show an identification document in order to check personal data. Otherwise they may refuse to dispense medicinal products.
(2) Authorised person may correct the data in the administrative section of the prescription in line with the provisions of the compulsory health insurance provider.
Article 47
(dispensing medicinal products in day-and-night duty)
During the day-and-night duty, an authorised person must dispense medicinal products prescribed on the same day or marked as urgent.
Article 48
(dispensing of interchangeable medicinal product, prescribed with proprietary name)
(1) As a rule, person authorised to dispense medicinal products shall dispense the proprietary medicinal product prescribed by the general practitioner.
(2) A medicinal product from the list of interchangeable medicinal products can be substituted by an adequate medicinal product from this list without prior consultation with the general practitioner, unless the general practitioner wrote “Do not substitute” on the prescription, thus indicating that substitution is not allowed, in the following cases:
- if extra payment is required for the prescribed medicinal product and the user or the person getting the medicinal product is not willing to pay such extra charge and is not able to provide other form of coverage, the prescribed medicinal product can be substituted with a less expensive medicinal product from the list;
- if it is not possible to obtain the prescribed medicinal product from the wholesalers.
In such cases, the authorised person must inform the user or the person getting the medicinal product of the prescribed medicinal product and adequate substitutes from the list of interchangeable medicinal products.
(3) The person authorised to dispense medicinal products must mark such substitution on the prescription form.
Article 49
(dispensing of interchangeable medicinal product, prescribed with common name)
(1) If a medicinal product is prescribed with a common name, the authorised person must inform the user or the person getting the medicinal product of available interchangeable medicinal products and potential extra charges. The authorised person shall dispense the appropriate medicinal product in agreement with the user or the person getting the medicinal product.
(2) The person authorised to dispense medicinal products shall mark the dispensed medicinal product on the prescription form.
Article 50
(prevention of complications due to interchange of medicinal product)
In case a medicinal product was substituted which the user has already been using before, the authorised person shall be obliged to issue the user precise written instructions for preventing potential complications due to the fact that the medicinal product was interchanged.
Article 51
(prohibited substitution of medicinal product)
The authorised person shall not be allowed to dispense the following medicinal products instead of the prescribed medicinal product without first consulting the general practitioner who issued the prescription:
- Similar medicinal product with the same quality and quantity composition of the active substance in the same pharmaceutical form;
- Medicinal product that is not on the list of interchangeable medicinal products.
Article 52
(dispensing medicinal products in the case of inadequately prescribed posology)
(1) If the posology on the prescription is inadequate (e.g. as instructed, as required) and the person authorised for dispensing cannot consult the general practitioner about adequate dose, they may only issue one smallest package of the medicinal product.
(2) The person authorised to dispense medicinal products shall mark the information on dispensed medicinal product on the prescription form.
Article 53
(dispensing medicinal products in the case of inadequately prescribed strength and quantity of medicinal product)
(1) If the general practitioner does not specify the strength or packaging or the number of treatment days when prescribing a proprietary medicinal product sold in various strengths or packages, the authorised person shall dispense the prescribed medicinal product in the smallest strength and packaging available.
(2) If the quantity of medicinal product is expressed with the number of treatment days, the authorised person shall dispense the smallest quantity of original packaging which shall be sufficient for the prescribed treatment days.
(3) The authorised person shall mark the information on dispensed medicinal product on the prescription form.
Article 54
(procedure in the event of inadequate prescription)
(1) The authorised person may not dispense a medicinal product on prescription if the expert section of such prescription is not in accordance with these Rules.
(2) If the prescription is not in accordance with these Rules, the authorised person must warn the general practitioner who issued such prescription about the established deficiencies in such a manner that the confidence of the person receiving the medicinal product in the general practitioner’s and the dispensing person’s work is maintained. If no agreement can be reached with the general practitioner, the authorised person shall return the prescription to the general practitioner or the user in an appropriate manner and with an adequate explanation.
(3) If the general practitioner who issued the prescription is not available, the authorised person shall proceed in the following way:
- If the maximum doses for the prescribed medicinal product are exceeded and the general practitioner did not specify the prescribed marks, the medicinal product is dispensed in medium prescribed dose;
- If a medicinal product is available in several pharmaceutical forms and the general practitioner did not specify which form should be dispensed, such form shall be dispensed that corresponds to the instructions for use without doubt;
- The general practitioner who issued the prescription shall be informed of any such fact as soon as possible;
- Any such measures shall be marked on the prescription form.
(4) In case of doubt, the authorised person shall return the prescription to the general practitioner who issued it or the user in an appropriate manner and with an adequate explanation.
Article 55
(dispensing medicinal products on renewable prescription)
(1) In every issue of medicinal product on renewable prescription, the authorised person must record the prescription in the record of renewable prescriptions in which it must enter the data from Items 1, 2, 9 and 10 of Article 24 hereof and the name and surname of general practitioner that issued the prescription. The number from the record of renewable prescriptions must be written on the prescription. Furthermore, the date and quantity of dispensed medicinal product must be written on the prescription. Records must be protected against possible abuse or destruction.
(2) Upon dispensing the medicinal product for the last time, the renewable prescription shall be kept by the pharmacy.
(3) Medicinal products dispensed on renewable prescription which are paid from health insurance may only be dispensed in line with these rules and in accordance with the regulations of the compulsory health insurance provider.
Article 56
(dispensing medicinal products containing narcotic and psychotropic substances)
(1) Medicinal products containing narcotic and psychotropic substances from groups II, IIIa and IIIc of the Production of and Trade in Illicit Drugs Act may only be dispensed to adult persons. When dispensing such medicinal products, the person getting them must show a valid personal ID.
(2) Pharmacies must keep a sealed book of records on the issue of medicinal products specified in the previous paragraph. Upon dispensing a medicinal product on special prescription and special order form, the authorised person must write the serial number from the book of records under which the dispensing of this medicinal product has been recorded.
(3) Authorised person must record in the officially sealed book of records also the amounts of dispensed substances from groups II, IIIa and IIIc of the Production of and Trade in Illicit Drugs Act used for the preparation of magistral formulae.
(4) The book of records referred to in the second and the third paragraphs hereunder must be numbered from the first to the last page and marked with the name and address of the pharmacy. Persons authorised to dispense medicinal products must keep in it the records of the following data:
1. Serial number;
2. Date of dispensing the medicinal product;
3. Name, last name and address of the user of medicinal product;
4. Name, last name and address of the person to whom medicinal product was dispensed;
5. Proprietary name, pharmaceutical form, strength, packaging and quantity of medicinal product;
6. Name and surname of the general practitioner who issued the prescription and address of the public institute or legal or natural person practicing medical activity where the general practitioner is employed, and serial number from the officially sealed book of records kept by the persons prescribing medicinal products; and
7. Signature or initials of the authorised person who dispensed the medicinal product.
(5) Pharmacies must also keep officially sealed books of records on the purchase, supply and stocks of narcotic and psychotropic substances from groups II, IIIa and IIIc of the Production of and Trade in Illicit Drugs Act.
(6) The books of records specified in this Article must be protected against possible abuse or destruction.
Article 57
(marking prescriptions upon dispensing medicinal products)
Upon each dispensing of medicinal products, the authorised person must initial the prescription form. The name of the pharmacy and date of dispensing medicinal products must be marked on the prescription in an indelible way.
Article 58
(labelling medicinal products with signature)
(1) The authorised person must label the dispensed medicinal product with a signature which must contain printed name and address of the pharmacy. The signature must be attached in the specified place determined in accordance with the provisions regulating the labelling of medicinal products.
(2) On such signature, the authorised person must write the instructions for dosing and using the medicinal product, mark the date of dispensing the medicinal product and initial it. If more detailed instructions for the use of medicinal product are necessary than those specified on the signature, such instructions must be provided on a separate sheet which must be signed and sealed.
(3) If necessary, the authorised person must label the medicinal product with other adequate warnings.
Article 59
(counselling obligation)
Upon each dispensing of medicinal product with or without prescription, the authorised person must counsel the user or the person to whom medicinal product was dispensed and provide information on correct and safe use of medicinal product.
Article 60
(restricted dispensing of medicinal products without prescription)
(1) The dispensed quantity of medicinal product for which no prescription is required and which may not be issued in the form of self-service shall be three smallest packages or one larger package per user.
(2) The body competent for medicinal products may further restrict the number of packages and number of units of a medicinal product for single dispensing to a single user without prescription for individual medicinal products in the marketing authorisation.
(3) If the authorised person suspects abuse, they may refuse to dispense a medicinal product for which no prescription is required.
Article 61
(delivery document upon dispensing medicinal products)
When dispensing a medicinal product on the basis of an order form, the authorised person must issue a delivery document to the user or the person getting the medicinal product, which must contain at least the following data:
1. Proprietary name of medicinal product;
2. Pharmaceutical form and strength of medicinal product;
3. Quantity of medicinal product;
4. Signature and printed name and surname of the pharmacist who dispensed the medicinal product;
5. Printed name and address of the pharmacy in which the medicinal product was dispensed;
6. Date of dispensing the medicinal product;
7. Other data related to the order form or delivery document or required by other provisions regulating medicinal products.
Article 62
(special delivery document upon dispensing medicinal products)
(1) When dispensing a medicinal product on the basis of a special order form, the authorised person must issue a special delivery document to the user or the person getting the medicinal product.
(2) The pharmacies must keep records of received special order forms and delivery documents in the manner enabling traceability.
(3) The records specified in the previous paragraph must be protected against possible abuse or destruction.
Article 63
(records of dispensed medicinal products)
Pharmacies must keep adequate records in computerised form, containing data on all dispensed medicinal products and in the case of medicinal products subject to medical prescription also on included users.
Article 64
(storing medical prescriptions, records and officially sealed books)
(1) Pharmacies must store medical prescriptions for at least three years of the date of dispensing the medicinal product concerned.
(2) Notwithstanding the provision from the previous paragraph, pharmacies must store special medical prescriptions and special delivery documents for at least five years of the day of dispensing the medicinal product concerned.
(3) Pharmacies must store officially sealed books of records on medicinal products containing narcotic and psychotropic substances for at least five years of the day of last entry concerning a medicinal product.
(4) Computer systems must enable insight in the records specified in the previous Article for at least three years.
(5) Pharmacies must store records referred to in Article 55 hereof for at least three years of the date of last entry.
(6) All documents hereunder must be stored in accordance with the provisions regulating the protection of archived material.
V. FINAL PROVISIONS
Article 65
(cessation of validity)
The Rules on the classification, prescribing and dispensing of medicinal products for human use (Official Gazette of the RS, nos. 59/03 and 114/03) and the Order on the determination of medicinal products dispensed with or without prescription only in pharmacies (Official Gazette of the Republic of Slovenia, no. 110/99) shall cease to apply on the date these Rules enter into force.
Article 66
(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.
No. 72-19/2008
Ljubljana, 20 June 2008
EVA 2008-2711-0007
Zofija Mazej Kukovič
Minister of Health