Pharmaceutical industry operators: The Brexit transition period ends on 31 December 2020
Fimea advises pharmaceutical industry operators to observe the expiry of the Brexit transition period on 31 December 2020, to carry out the necessary transfers and to submit the appropriate variation applications with regard to marketing authorisations currently in force in Finland.
The import of medicinal products into EU countries requires that the marketing authorisation or registration holder as well as the manufacturer responsible for the finished medicinal product and the quality assurance batch control are located in the EU area. Additionally, the qualified person responsible for pharmacovigilance (QPPV) and the pharmacovigilance system master file (PSMF) of the medicinal product concerned must be located in the EU area.
Variation applications concerning the aforementioned transfers must be submitted as soon as possible to allow sufficient time for processing the applications well on time before the end of 2020.
See the Frequently Asked Questions section for more information
For further information, please contact:
Medicinal products intended for human use:
Päivi Jutila, Coordinator for Marketing Authorisations, tel. +358 29 522 3365
Medicinal products intended for veterinary use:
Heidi Mustalammi, Procedure Manager, tel. + 358 29 522 3329
E-mail address format: firstname.lastname@example.org