Industry Regulations
FIMEA – Finnish Medicines Agency
The advertising of medicinal products is prescribed under:
- Medicines Act (395/1987), §§91–93
- Medicines Decree, §§25, 25a–i §
- Consumer Protection Act (38/1978)
The Finnish Medicines Agency FIMEA is the national competent authority for regulating pharmaceuticals. As a central administrative agency operating under the Ministry of Social Affairs and Health it promotes the health and safety of the population by regulating medicinal, blood and tissue products, and by developing the pharmaceuticals sector.
Fimea has the power and jurisdiction to decide whether promotion of a medicinal product is considered to be in accordance with the Medicines Act and Medicines Decree and by general legislation regarding consumer protection.
The Finnish Medicines Agency Fimea monitors the advertising of medicinal products.
In Finland, the promotion of pharmaceuticals is regulated both, by general legislation regarding consumer protection and by the provisions of the Medicines Act and Medicines Decree. Sections 91-93 of the Act and section 25 of the Decree specify in detail the minimum information that must be included, and the restrictions to be observed, when marketing medicinal product. The legality of marketing is monitored by the Finnish Medicines Agency FIMEA.
All statutes regarding the marketing of pharmaceuticals are based on the EU Directive 2001/83/EC relating to products for human use. General rules are that only pharmaceuticals with a marketing authorisation may be advertised in Finland.
The information provided in advertising must be in accordance with the up-to-date Summary of Product Characteristics (SmPC) approved in conjunction with the marketing authorisation. On Prescription Only Medicines (POM) may only be promoted to MDs and pharmacists in Finland. (not for nurses).
All promotion of medicines has to be in accordance with Medicines Act and Medicines Decree referring to appropriate factual information content, legal focus group and moderate level of hospitality. Every campaign is evaluated case by case.
It is not possible to advertise medicinal products in Finland without marketing authorization.
The following Information was given by FIMEA
According to FIMEA, there is no room for leverage: promotion of products that do not have MA in Finland is prohibited.
FIMEA will allow mention of the product portfolio (also products not approved in Finland) in a corporate company description, but not in any kind of promotional form, ie no mention of claims, indications, SpcP etc.
FIMEA also clarified by phone that mention of products without MA in Finland in corporate communication, where the information about the company is central and not the products, ie annual reports, press releases etc is allowed.
Exhibition booths: FIMEA assesses the campaign (in this case and exhibition stand) as a whole and the setting must be corporate and mention of the products must be in the corporate setting only.
If mention is made of products without MA in Finland, it cannot stand on its own but must have a dominance of corporate information about the company in the same place. FIMEA also said that if products are mentioned that do not have MA in Finland, in such a corporate setting, all products must be mentioned (also in other therapeutic areas) and not only a selection directly relevant to the congress delegates.
IMPORTANT INFO
Please note: EAACI does not take responsibility for completeness or correctness of this information. It is the company’s responsibility to investigate and comply with regulations.