According to the European Medicines Agency (EMA),marketing authorization holders (MAHs), applicants and sponsors of centrally authorized medicines for human or veterinary use should consider how Brexit will impact their medicines and which changes need to be addressed before the UK leaves the EU. They also need to ensure that the necessary changes are made by that date.
16. What Brexit-related changes to the Product Information can I include as part of other procedures affecting MA Annexes?
Official Control Authority Batch Release:
17. How should I notify the change of Official Medicines Control Laboratory (OMCL) currently in the UK?
National scientific advice issued by UK authorities:
18. How shall I reflect UK national scientific advice in submissions made after 29 March 2019?
In addition, EMA´s “Q&A” paper regarding aspects of the Brexit has been amended by the following with regard to medicines for human use:
19. What if my product is subject to Official Control Authority Batch Release (OCABR) and is currently tested by a UK Official Medicines Control Laboratory (OMCL)?
21. How does UK’s withdrawal from the Union affect the status of inspection outcomes by the UK competent authority?
24. How does UK’s withdrawal from the Union impact on the possibility to market a multi-country pack which includes the UK?
25. What if Qualified Person’s for Pharmacovigilance (QPPV) back-up arrangements are in the UK?