Marketing Authorisation Holders should prepare for Brexit

Fimea reminds all Marketing Authorisation Holders to prepare for the possible changes caused by Brexit.  So far only a few applications to transfer the Marketing Authorisation Holder (MAH) have been submitted to Fimea. Therefore Fimea encourages MAHs to submit MAH transfer applications as soon as possible, in order to avoid the database being congested at the end of March 2019.

Fimea has published Frequently asked questions about Brexit according to the current information.  These Frequently asked questions will be updated when necessary.