Slovakia: restrictions on advertising medicinal products
EU regulations on advertising medicinal products have been incorporated into Slovakian law in a new Amendment to Advertising Act.
Requirements
All medicinal product advertising must:
- comply with the information on the product leaflet
- promote judicious use of the medicinal product
- not be deceiving
- make it clear that the information is advertising
- make it clear that the subject of the advertising is identifiable as a medicinal product
- contain the name of the medicinal product, instructions on its appropriate use, appeal on attentive reading of instruction on its appropriate use
- contain a special statutory narrative where traditional herbal formulations are promoted
Prohibitions
All medicinal product advertising must not contain any information as for example:
- giving the impression that a medical check-up or intervention is unnecessary
- offering a diagnosis and treatment by correspondence
- addressing children as the primary audience
- implying that the condition of someone otherwise in good health could improve after using a specific medicinal product
- use excessive, threatening or deceptive images of changes in the human body due to an illness or injury to illustrate the effects of a medicinal product on such illness or injury
There is a total ban on the advertising of:
- prescription medicines for example: anabolic steroids or other drugs
- medicinal products not registered in Slovakia
- medicinal products containing intoxicating substances
- non-prescription formulations which are covered by public health insurance
There is also a ban on the distribution of medicinal products directly to the public for advertising purposes by marketing authorisation holders and their representatives.
What advertising covers
Medicinal product advertising includes:
- door-to-door distribution of information
- recruiting activities
- incitements to prescribe, issue, sell or consume medicinal products
- advertising which targets the public
- advertising which targets persons authorised to prescribe and issue medicinal products
- visits aimed at promoting medicinal products by agents of the marketing authorisation permit holder
- the offering of samples of medicinal products to the public or persons authorised to prescribe and issue medicinal products
- the provision of incentives (other than those of negligible value) to sign or issue medicinal products, such as donations, offers and pledges
- sponsorship of promotional events and scientific congresses attended by persons authorised to prescribe or issue medicinal products
Medicinal product advertising does not include:
- labelling and written information about the product earmarked for users
- correspondence which is supplemented by non-promotional material necessary to answer a special question concerning a medicinal product
- reference material and information on changes in product packaging
- warnings of possible side effects
- retail catalogues and price lists which don’t contain information on medicinal products
- information on human health and illnesses with no direct or indirect references to a medicinal product
Responsibility for compliance
Marketing authorisation holders are made responsible for ensuring that any advertising promoting their medicinal products complies with the statutory requirements. They are also required to give the State Drug Supervisory Body advance copies of any advertising materials being prepared at least once every three months.
The maximum fines for breaching the statutory requirements are:
- SKK 50,000 for persons authorised to prescribe and issue medicinal products
- SKK 50,000 for medical representatives
- SKK 2 million for advertising promoters and marketing authorisation holders
- SKK 5 million for advertising customers
Other requirements
Whenever a marketing registration holder offers product samples, the samples must indicate in writing that they are a free medical sample not for sale, to be provided upon request in writing, in an amount no larger than two samples of the smallest medicinal product packaging a year and only to a person authorised to prescribe medicinal products.
Marketing authorisation holders (or applicants) are also required to ensure that:
- the outer packaging of all medicinal product labelling includes an inscription in Braille
- where the outer packaging contains inscriptions in more than one language, the name of the product must be in Braille in all such languages
Law: amendment to the Act no. 140/1998 Coll. providing for medicinal products and tools published in the Collection of Statutes under no. 342/2006
