As of the date of the withdrawal of the UK from the EU, active substances manufactured in the UK will be considered “imported” active substances and other headaches

The European Medicines Agency issued a Q&A to address some Brexit issues that will directly impact US sponsors/manufacturers.

The EMA offers no specific guidance on the transfer and/or handling of clinical trials that are ongoing on the date that the UK leaves the EU, but the guidance does give us an idea of how complicated this is all going to be. Nota bene the issue caused by having one’s Qualified Person in the UK (which is 98% of US manufacturers, followed only by QPs in Ireland). We will continue to follow the EU’s guidance and will craft our EU contracts in such as way as to make the transfer as painless as possible.