Fimea publishes information on granted exemptions starting 1.5.2020
If justified, Fimea may grant a batch-specific exemption from the conditions of a marketing authorisation or registration, if a medicinal product is critical for the Finnish pharmaceutical services and its availability would otherwise be jeopardised (Fimea regulation 04/2019, Applying for and maintaining a marketing authorisation for a medicinal product).
Particulars of granted exemptions will be listed on Fimea’s webpage starting 1.5.2020. The list is primarily meant to ease the work in pharmacies and hospital pharmacies and is provided in Finnish and Swedish.
The following particulars will be published:
- The product, for which the exemption is granted
- Package sizes
- Name of the marketing authorization holder
- Type of deviation: Package in foreign language/other reason
- Batch numbers or period, for which the exemption is granted
- Date of the exemption decision
- The name of the product in foreign language package (if relevant).
Granted exemptions (in Finnish)
- Anniina Ritvanen, Research-Coordinator, tel. +358 29 522 3450
- E-mail address format: firstname.lastname@example.org