The EU Commission and EMA made a clear statement that after 30 March 2019, the Unit Kingdom will become a 'third country'.
In a common Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use, the Commission and the Agency get the point strait that "all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019, 00:00h (CET). That means that the U.K. will "become a 'third country'".
What does this mean for marketing authorisation holders? In the document, important aspects are listed which will need to be considered:
- EU law requires that marketing authorisation holders are established in the EU (or EEA). That means a pharmaceutical company will need a registered and licenced office or facility with licence in the EU/EEA.
- Some activities like, for example, batch release and pharmacovigilance activities must be performed in the EU (or EEA). So QP and QPPV must be located in the EU/EEA.
- Possible changes to the terms of the marketing authorisation "in order to ensure its continuous validity and exploitation" should be considered.
As a further step a series of Questions and Answers will be provided and the EMA's website will constantly be updated.