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null The administrative regulation 3/2015 ”Applying for and maintaining a marketing authorisation and registration for a medicinal product” has been updated

The administrative regulation 3/2015 ”Applying for and maintaining a marketing authorisation and registration for a medicinal product” has been updated

20.12.2017

The administrative regulation 3/2015 of the Finnis Medicines Agency ”Applying for and maintaining a marketing authorisation and registration for a medicinal product” has been slightly updated. 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.

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2/2017 Applying for and maintaining a marketing authorisation and registration for a medicinal product (updated version published on December 21st, 2017)

Updated December 21st, 2017. Published an updated version of the administrative regulation.

 

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  • Tuomo Lapveteläinen, senior medical officer, tel. 029 522 3375
  • Leena Pietilä, head of unit, tel. 029 522 3360
  • Liisa Näveri, head of unit , tel. 029 522 3340
  • The e-mail addresses have the form firstname.lastname@fimea.fi