Fimea amended regulation 3/2015 Applying for and maintaining the marketing authorisation and registration for a medicinal product
The Finnish Medicines Agency Fimea has amended the regulation concerning applying for and maintaining the marketing authorisations or registrations. The amended Fimea regulation 3/2015 “Applying for and maintaining marketing authorisation and registration for a medicinal product” will enter into force on January 1, 2016 and will supersede the previous Fimea regulation 2/2013.
The most essential changes concern processing fees and times, delivery of national patient information documents and cancellation of marketing authorisation or application for marketing authorisation. The contents of the regulation have been amended in order to comply with the current legislation.
- Tuomo Lapveteläinen, senior medical officer, tel. +358 29 522 3375
- Leena Pietilä, process manager, tel. +358 29 522 3360
- The format of e-mail addresses is firstname.lastname@example.org