Fimea issues guidelines applicable in Finland regarding the advertising of medicines under additional monitoring
Fimea is issuing more detailed guidelines regarding the colour, size and location of the inverted black triangle and the standardised explanatory sentence for the advertising of medicinal products under additional monitoring. The guidelines apply to all marketing authorisation holders and interest groups involved in the marketing of medicinal products.
The inverted black triangle and the accompanying standardised explanatory sentence represents information necessary for the correct and safe use of a medicinal product referred to in Section 91 a of the Medicines Act, and essential information on the medicinal product and its use referred to in Section 91 b of the Medicines Act. This information must be displayed whenever medicines under additional monitoring are advertised.
During the year, the inverted black triangle and the standardised explanatory sentence have been presented in many advertisements for medicinal products published in medical journals or on websites in a way that has been inconsistent with Fimea’s guidelines, e.g. in different colour, too small, or attached to the logo of the medicinal product. The purpose of more detailed guidelines is to achieve appropriate markings in all advertisements for medicines under additional monitoring.
- Liisa Näveri, Head of Section, tel. +358 29 522 3340
- Kristiina Pellas, Senior Pharmaceutical Inspector, tel. +358 29 522 3422
- Email address format firstname.lastname@example.org.