Guidelines for when 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 batch release 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. When the transition period has ended, medicinal products manufactured in the UK and sent from there to the EU/EEA or intended for the EU/EEA market will be imported medicinal products, and, that being the case, the manufacturer responsible for importation has to be located in the EU/EEA.
Variation applications concerning the aforementioned transfers must be submitted as soon as possible and in any event no later than the start of 2021, to allow sufficient time for processing them. This also applies to the removal of obsolete UK sites mentioned in the marketing authorisation dossier.
Further instructions for pharmaceutical industry operators can be found on the websites of the EMA and CMDh/CMDv, which also give advice related to the implementation of the Protocol on Ireland / Northern Ireland.
EMA: Brexit related guidance to companies
CMDh: Human medicines/Brexit
CMDv: Veterinary medicines/Brexit
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
Paula Kajaste, Coordinator for Marketing Authorisations, tel. + 358 29 522 3395
E-mail address format: email@example.com