No-Deal Brexit Guidance for Clinical Trials

30 January 2019

GMP News

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) released further guidance on the regulation of medicines, medical devices and clinical trials if there is no Brexit deal. The scenario of a so called “Hard Brexit” (U.K. to leave the EU with no deal*) is still a possibility and people need to think about this and make the necessary preparations.

As a response to the recent EU exit no-deal legislative proposals, the MHRA has issued an updated guidance defining some proposed arrangements if the U.K. will leave the EU on 29 March 2019 with no deal.

For Clinical Trials of investigational medicinal products (IMPs), some of the key arrangements include:

*UK would leave not only the EU but also the EU’s Single Market (of which non-EU countries are also members) and the EU Customs Union (of which non-EU countries are also members).

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