R U L E S on advertising of medicinal products
 

I. GENERAL PROVISIONS
Article 1
(Scope of application)
These rules determine detailed conditions and the way of advertising of medicinal products in humane and veterinary medicine (herein after referred to as: medicinal products) in accordance with the Directive 2001/83/EC of the European Parliament and Council on 6th November 2001 about the rules of use of the medicinal products for human use. 311 of 28th November 2001, p. 67), last revised with the directive 2008/29/EC of the European Parliament and Council on 11th March 2008 about the change of Directive 2001/83/EC of rules of Union about the medicinal products for human use according to the implementing powers granted to the Commission (OG no 81 of 20th March 2008, p. 51) (hereinafter: Directive 2001/83/EC and Directive 2001/82/EC of the European Parliament and Council of 6th of November 2001 about the rules of Union on medicinal products for veterinary use (OG no. 311 of 28th November 2001, p. 1), last revised with the directive 2004/28/EC of the European Parliament and Council on 31th March 2004 about the change of Directive 2001/82/EC of rules of Union on the medicinal products for human use according to the implementing powers granted to the Commission (OG no 136 of 30th April 2004, p. 58) (hereinafter: Directive 2001/82/EC).
 

Article 2
(Definition of advertising)
(1) Advertising of medicinal products includes all forms of informing, including door to door advertising, propaganda and stimulation intended for promotion of prescribing, issuing, selling and using of medicinal products.
(2) According to the target groups we divide advertising on:
advertising in general public and advertising in expert public.
 

Article 3
(Definition of general public and expert public)
(1) General public are common groups and individuals which do not belong to the expert public as stated in these rules.
(2) Expert public are persons authorized for prescribing and issuing of medicinal products.
 

Article 4
(Extent of advertising)
(1) Advertising in general public are all forms of promotion and ways of informing of common groups and individuals.
(2) Advertising in expert public is:
- informing persons authorised for prescribing and issuing of medicinal products with the characteristics and effects of medicinal products including informing those persons directly; - auspice and organization of promotional meetings in which participate persons authorised for prescribing and issuing of medicinal products; - auspice of scientific congresses in which participate persons authorised for prescribing and issuing of medicinal products; - the supply of samples in accordance with Article 22 of these rules.
(3) Advertising in expert public includes also stimulating to prescribe or dispense by offering financial or material goods in accordance with Article 20 of these rules.
 

Article 5
(Elimination from advertising)
Advertising or advertising material does not include: - package and package leaflet approved with marketing authorisation; - informative announcements relating to the approved package changes, warnings of side-effects and other general precautions for the purpose of safer and more efficient use of a medicinal product; - trade catalogues and price lists which do not include information about the characteristics of a medicinal product; - correspondence about specific questions regarding certain medicinal product, including enclosed material of non-promotional nature; - announcements and material of the institution, authorised for the implementation of programmes for prevention, control, elimination and eradication of infectious diseases about the vaccination against individual diseases, in which there is no direct mention of an individual vaccine, its effect and other specific characteristics; - information relating to the people's health or diseases, provided that no direction, not even indirect, to medicinal products exists. Information have to be qualitative, objective, unambiguous, integral, balanced, comprehensible to users and must not include elements of direct or hidden advertising.
 

II. CONDITIONS FOR ADVERTISING
Article 6
(Marketing authorisation holder)
Only marketing of the medicinal products with marketing authorisation in accordance with the Medicinal Products Act (Official Gazette of the Republic of Slovenia, No 31/06 in 45/08, hereinafter: Act).
 

Article 7
(Accordance with the summary of the main characteristics of a medicinal product)
Each individual element of advertising and all parts that represent integral unit for a recipient have to be in accordance with the approved summary of the main characteristics of a medicinal product. All characteristics of a medicinal product have to be presented in balance.
 

Article 8
(Sensible and safe use of a medicinal product)
(1) Objective advertising of a medicinal product without exaggeration about its characteristics has to stimulate its sensible and safe use.
(2) In order to achieve the goal from the previous paragraph the competent authority can in the process of acquisition and maintenance of the marketing authorization require special warnings which have to be part of every advertising.
 

Article 9
(Fraudulent advertising)
Advertising must not be fraudulent regarding any benefits or risks of using a medicinal product by which we have to consider the integrity of advertisement and the impression of message.
 

Article 10
(Protection of the Slovene language)
(1) Advertising must be in the Slovene language; on the territories of Italian and Hungarian minority it can be in Hungarian and Italian language respectively.
(2) Irrespective of the previous paragraph the literature for expert public, which is attached to the advertising material, can be also in the source language. In the international expert meetings on the territory of the Republic of Slovenia the advertising messages and materials may be also in the language of a event of in the languages of participants.
 

Article 11
(Responsibility)
The responsibility for ensuring compliance of advertising with these rules rests with the marketing authorisation holder or the ordering party but the responsibility for unconsidered provisions about the advertising of medicinal products rests on any responsible person involved in the incorrect promotion of medicinal products.
 

III. ADVERTISING IN GENERAL PUBLIC
Article 12
(Advertising in general public)
(1) In general public only the advertising of the medicinal products dispensed without prescription is allowed and those of which the holder of authorisation defines in the marketing authorisation.
(2) Advertising and publishing of the information about medicinal products which contain psychotropic and narcotic substances from the international conventions such as United Nations Single Convention on Narcotic Drugs from 1961 and United Nations Convention on Psychotropic Substances from 1971 is not prohibited in general public. (3) Advertising of veterinary medicine products which can be used as growth promoters or production stimulator (for example, hormones, beta-agonists, thyrostatic substance, bovine somatrophin).
 

Article 13
(Advertising conditions in general public)
Advertising of medicinal products in general public has to have clearly message and is unambiguous presented as a medication.
 

Article 14
(Advertising content in general public)
(1) Advertising of each medicinal product in general public has to involve the following data:
- The name of a medicinal product and general name if the product contains only one substance, “Read all of this leaflet carefully before you start taking this medicine. Regarding risks and undesirable side-effects please consult your doctor or pharmacist.”- - visibly and legibly written, graphic or oral warning about the importance of leaflet enclosed to a medicinal product with the following words in medicinal products for veterinary use: “Read all of this leaflet carefully before you start taking this medicine. Regarding risks and undesirable side-effects please consult your doctor or pharmacist.”
(2) Written warning from the previous indent must be emphasized (for example: in bold, coloured, in a frame) in the size of one-tenth of the size of an advertisement and written in suitable font in order not to overlook but read it easily. In the advertisements on television the warning must be displayed independently with an image (text) and orally. Oral warning must be realized in the standard language clearly and intelligibly and has to assure the seriousness of message. Electronic media advertisements must display the warning as an integral part of the main page of an advertisement and not only as a hyperlink to it. The warning must be emphasized (for example: in bold, coloured, in a frame) in the size which is not smaller than one-fourth of the screen when displayed on the whole screen, and with the font which is not smaller than one-tenth of the side of the warning field.
 

Article 15
(Advertising in general public)
(1) Advertising of each medicinal product in general public must not involve the following data:
- give impression that consulting a doctor or veterinary or surgery is unnecessary especially with assigning diagnosis or suggestion for treatment by post; - indicate that the effects of a medicinal product are absolutely assured; that a medicinal product is free of side effects; that certain medicinal product is better or equivalent to other treatment or other medicinal product;- indicate that health condition of a person or animal can be improved only because of taking the advertised medicinal product;- indicate that health condition of a person or animal can be improved only because of taking the advertised medicinal product;- indicate that health condition may get worse without taking the advertised medicinal product; this prohibition is not valid for vaccination programmes and advertising of vaccine in compliance with the article 24 of these rules; - medicinal products that are aimed exclusively or predominantly at children;- refer to recommendations by scientists, health professionals in the field of medicinal products for human use or veterinary medicine, or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products; - indicate that a medicinal product is food, cosmetic or any other consumer product; - indicate that safety and effectiveness of a medicinal product result from the natural origin; - data that may lead to incorrect self-diagnosis due to the description or detailed presentation of anamnesis;- uses of 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.
(2) Direct distribution of medicinal products to consumers for promotional purposes is prohibited.
 

IV. ADVERTISING IN EXPERT PUBLIC
Article 16
(Advertising in expert public)
(1) The holder of the marketing authorisation or advertiser is obliged to take care that is any advertising in expert public designed for and forwarded only to the persons authorised to prescribe or dispense medicinal products.
(2) Informational kit, designed for expert public, has to be labelled “For expert public only.”
 

Article 17
(Advertising in expert publications)
The marketing authorisation holders may advertise the medicinal products which acquired marketing authorisation to expert public in professional books, journals and other professional publications.
 

Article 18
(Advertising with direct informing)
(1) Marketing authorisation holders can advertise medicinal products also by direct informing persons authorised for prescribing and dispensing of medicinal products.
(2) All information about medicinal products, which are designed for persons who are authorised for their prescribing and dispensing, have to involve especially the following data:
- name of a medicinal product - the medicinal products for human use have to include basic information from the summary of the main characteristics of a medicinal product such as: - composition of a medicinal product, therapeutic indications, dosing and using of medicinal product, summary of adverse-reactions, general precautions and warnings, contradictions and interactions, name, sign and address of a marketing authorisation holder; - the medicinal products for veterinary use have to include basic information from the summary of the main characteristics of a medicinal product such as: - composition of a medicinal product, therapeutic indications, dosing and use of medicinal product, summary of adverse reactions, general precautions and warnings, contradictions and interactions, name, sign and address of a marketing authorisation holder, species of origin, abstinence; - - --- - method and regime of dispensing and prescribing a medicinal product; - the date of preparation of information.
(3) Beside the data from the previous paragraph the information can involve also the data about a payer of a medicinal product or listing of a medicinal product on an appropriate list.
(4) All information from this article has to be accurate, unambiguous, topical and verifiable to enable the evaluation of operating and therapeutic value of a medicinal product.
(5) All quotations and tables and other graphic material from medical publications and other scientific literature have to be authentically summarised with exact list of sources.
 

Article 19
(Visits of medical sales representatives)
(1) Direct informing about medicinal products can be performed by medical sales representatives if they fulfil the following conditions:
medical sales representatives for medicinal products for humane use have to hold an university degree in pharmacy or medicine, or an university degree in natural sciences or biomedicine, and additional knowledge in the field of medicinal products; medical sales representatives for veterinary medical products have to hold an university degree in veterinary medicine or an university degree in natural sciences or biomedicine, and additional knowledge in the field of medicinal products; have to be properly qualified to give accurate and complete expert information about a medicinal product.
(2) Medical sales representatives have to forward the information about a medicinal product accordant with the approved summary of the main characteristics to persons, who are authorised for their prescribing and dispensing. This summary must be submitted in writing or must be available.
(3) Medical sales representatives are obliged to transmit all information about adverse reactions as well as clinically important information regarding the use of a medicinal product to a marketing authorisation holder. The information is obtained from the persons authorized for prescribing and dispensing medicinal products.
 

Article 20
(Giving presents)
Marketing authorisation holders, producers of medicinal products, legal entities or natural persons, who are representatives of a company, or legal entities or natural persons, who sale medicinal products and the branch offices of foreign producers must not supply, offer or promise any presents, pecuniary benefits or benefit in kind, only if they are inexpensive and relevant to the practice of medicine, veterinary or pharmacy, to persons authorised for prescribing and dispensing of medicinal products.
 

Article 21
(Promotional meetings)
(1) Regardless of the provision of the previous article, may marketing authorisation holders, producers of medicinal products, legal entities or natural persons, who are representatives of companies, and legal entities or natural persons, who sale medical products, and the branch offices of foreign producers, enable to acquire additional knowledge about new findings about medicinal products. Acquiring additional knowledge must not exceed professional and scientific goals of such education, it has to be subordinated exclusively to the acquiring of knowledge and designed only for persons who are responsible for prescribing and dispensing of medicinal products.
(2) Moderate hospitality in promotional meetings is required and it has to be secondary to the main purpose of the meeting; it must not involve persons who are not responsible for prescribing and dispensing medicinal products.
(3) Persons responsible for prescribing and dispensing of medicinal products are not allowed to attempt to acquire any benefit, which is in the opposition to the paragraph 1 and 2 of this article.
 

Article 22
(The supply of samples)
(1) Exceptionally may producers of medicinal products and legal entities and natural persons, who are representatives of a company, persons responsible for prescribing medicinal products submit free samples of prescription-only medicinal products in order to inform them about new medicinal products if the following conditions are fulfilled:
a medicinal product has marketing authorisation in accordance with the law; from acquisition of the marketing authorisation or approval of the marketing authorisation has not passed more than two years; number of samples of each medicinal product for each authorised person for prescribing medicinal products must not exceed 30 defined daily dose per year; receiver has to apply for free samples in writing. Application must be signed and dated; receiver must keep a register of received samples; receiver must not sell received samples; producers of medicinal products or legal entities or natural persons, who are representatives of a company, must keep a register and have established control on free samples; samples must be in the smallest packaging available; each sample has to be in packaging with leaflet enclosed and approved with marketing authorisation, and marked “free medical sample - not for sale”; to each sample approved Summary of Product Characteristics must be enclosed; - a sample must not contain narcotic and psychotropic substances.
(2) Submitting samples which require special storage conditions, such as cold chain, is prohibited.
 

V. EXPERT SERVICE
Article 23
(Expert Service)
(1) The holders of marketing authorisation must establish service for preparing information about marketed medicinal products.
(2) Responsible person of authorisation holder must:
provide samples of all promotional materials within the mentioning of target groups, method of dispatching and the date of first dispatch to the authority competent for the supervision of medicinal advertising and other supervisory bodies; provide the maintenance of a register of submitted free samples of medicinal products, which has to include written applications of authorised persons for prescribing of medicinal products pursuant to the fourth indent of the first paragraph hereunder. Register has to be kept for at least three years: it has to ensure that medicinal products are advertised in accordance with these rules; check if sales representatives are properly qualified to give accurate and complete expert information about a medicinal product and perform activities in accordance with these rules; submit all information regarding advertising to the body authorised for supervision of advertising of medicinal products and other supervisory bodies; ensure that decisions of supervisory bodies are considered instantly and entirely.
 

VI. ADVERTISING OF VACCINE
Article 24
Advertising of vaccine
(1) Advertising of vaccination medicinal products is allowed by the body authorised for medicinal products.
(2) Advertising under the conditions stated in the previous paragraph must include the following warning: “Please consult your doctor regarding risks and undesirable side-effects before vaccination, “ which must meet, as appropriate, the conditions delineated in the article 14 of these rules.
 

Article 25
(Approval of advertising of vaccine)
(1) For precedent approval of advertising from the previous article, the marketing authorisation holder must apply to the body authorised for medicinal products. The application shall include:
an accompanying letter the proposal of grounded advertising materials within the mentioning of target groups, method and time line of advertising and evidence of paid costs of procedure and administrative duty.
(2) The authority competent for medicinal products decide on applications within 60 days from receiving the complete application.
 

VII. ADVERTISING OF OTHER SPECIAL GROUPS OF MEDICINAL PRODUCTS
Article 26
(Advertising of traditional and homeopathic medicinal products)
(1) Traditional medicinal products of plant origin may be advertised in accordance with these rules and the rules regulating traditional medicinal products of plant origin.
(2) Homeopathic medicinal products may be advertised in accordance with these rules and the rules regulating homeopathic medicinal products.
 

VIII. ADVERTISING MONITORING
Article 27
(Advertising monitoring)
The body competent for medicinal products may establish permanent commission of expert in the field of advertising or the representatives of interested public to monitor compliance of advertising with these rules.
 

IX. TRANSITIONAL AND FINAL PROVISION
Article 28
(Cessation of validity)
The Rules on the Advertising of Medicinal Products and Devices (Official Gazette of the Republic of Slovenia, No 76/01) shall cease to apply in the part that relates to the medicinal products, and The Rules on the Advertising of Medicinal Products for Veterinary Use (Official Gazette of the Republic of Slovenia, No 70/03) on the date these Rules enter into force. 70/03).
 

Article 29
(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. 72-16/2008
Ljubljana, 20 June 2008
EVA 2008-2711-0028
Zofija Mazej Kukovič
Minister for health I hereby agree.
Iztok Jarc
Minister for Agriculture, Forestry and Food