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Finland: FIMEA Updated Regulation on Applying for and Maintaining a MA and Registration for a Medicinal Product

Friday, December 15, 2017: The Finnish Medicines Agency (FIMEA) has updated administrative regulation 3/2015”Applying for and maintaining a marketing authorisation (MA) and registration for a medicinal product”. FIMEA is no longer requiring Finnish and Swedish translations of the risk management plan summary. The number of the administrative regulation changes from 3/2015 to 2/2017.

This administrative regulation covers marketing authorisation and registration applications for medicinal products for human and veterinary use. It also covers applications for variations and renewals concerning these products as well as other applications relating to the maintenance of a marketing authorisation or registration. The administrative regulation does not cover the EU’s centralised marketing authorisations procedure except where the latter applies to the placing of products on the market, dose dispensing, or the availability on the market of a product in packages of two different holders, in two different compositions or under two different names.

The FIMEA administrative regulation on parallel import applies to the parallel import of medicinal products.

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