Validity of marketing authorisations
According to Regulation (EU) 2019/6 of the European parliament and of the council has a marketing authorisation for veterinary medicinal products unlimited validity.
A marketing authorisation issued for a limited market is valid for a period of five years. After that it has to be re-examinated. An application for re-examination has to be submitted at least six months before expiry of the marketing authorisation.
Further information
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Aromaa Virve
Head of Section, Coordinator for Marketing Authorisations / Fimea, Myyntiluvat, Eläinlääkeyksikkö, Eläinlääkkeiden hakemusprosessit tel. +358295223302 firstname.lastname@fimea.fi