Brexit

Brexit and the pharmaceutical sector

With the UK's withdrawal from the EU on 31 January 2020, a transition period will begin until the end of 2020. During the transition period, the current rules will continue to be in place as if the UK were still a member of the EU. The EU and the UK will negotiate their future relationship during 2020. Due to the tight negotiation schedule, some sectors may fall outside the scope of the agreement starting on 1 January 2021. Businesses in particular should be prepared for this possibility.

Together with the Ministry of Social Affairs and Health, other authorities and operators, Fimea has prepared for Brexit. Fimea and other pharmaceutical operators have mapped possible disturbances in the pharmaceutical services and the related risks. Cooperative measures have been initiated to prevent potential disruptions and efforts are continued in close cooperation to ensure uninterrupted patient treatment.

Read more:

Information about Brexit (Prime Minister's Office)

Questions & answers: EU actions to prevent medicine shortges due to Brexit (EMA 31/01/20120)

Brexit for marketing authorisation holders

Common guidelines from the Commission to prevent problems in the supply of medicines

Brexit related batch control testing exemption request submissions to Fimea

Preparations for Brexit well underway in the pharmaceutical industry

Marketing Authorisation Holders should prepare for Brexit

Preparations for Brexit in social security provision and pharmaceutical service (stm.fi)

Marketing Authorisations

Withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medicinal products (EC 13.3.2020)