Fimea issued Fysioline Oy with a marketing ban decision concerning the use of starter packs of the Trampalgin medicinal product in marketing
By its decision issued on 26 June 2019 (Ref. no. 001377/06.08.03.00/2019), the Finnish Medicines Agency Fimea has prohibited Fysioline Oy from continuing or renewing the use of starter packs of the Trampalgin medicinal product in the marketing of the medicine concerned.
Pursuant to section 25g of the Medicines Decree, starter packs may not be used in the marketing of medicinal products, and under this provision, Fimea prohibits Fysioline Oy from continuing to use starter packs in its marketing by, for example, distributing them in connection with pharmaceutical presentations by pharmaceutical sales representatives.
The marketing ban decision is reinforced by a conditional fine of EUR 70,000.
Fimea emphasises that ordering, handing over and acknowledging a starter pack of a medicine must take place entirely separate from the marketing of the medicine concerned. A pharmaceutical sales representative may not hand over starter packs to a physician at the close of a pharmaceutical presentation based on an oral or written order or acknowledgement made at that same moment.
Fimea oversees the appropriateness of the marketing of medicinal products as a whole in accordance with the instructions provided in the Medicines Act and Decree.
- Esa Heinonen, Director, tel. +358 29 522 3300
- Liisa Näveri, Head of Section, tel. +358 29 522 3340
- Juliana Raitis, Legal Advisor, tel. +358 29 522 3656
- Kristiina Pellas, Senior Pharmaceutical Inspector, tel. +358 29 522 3422
- Email address format: firstname.lastname@example.org