News about GMP/cGMP


EMA/EC: Brexit Guidance Documents Updated

The European Medicines Agency and the European Commission have updated the following three documents related to Brexit that are intended to complement each other:

The Q&A document (Rev 4) features an overall of 37 questions – 14 of which are new. The new questions concern the topic of safety features, parallel distribution or the supervision of manufacturing sites previously supervised by UK authorities. Addressed is a situation where the UK becomes a third country on 30 March 2019 without an agreement.

The Practical Guidance (Rev 3) has been developed taking into consideration that as of 30 March 2019 the United Kingdom will become a third country. As a result, MAHs and applicants of centrally authorised products for human or veterinary use need to ensure that the necessary changes are made by the 30 March 2019, to allow for the continued marketing of their medicine in the Union after Brexit. The document, also in Form of Q&As, has been amended with 11 additional questions.

The document on legal obligations (Rev 2) points out the basic requirements to be fulfilled once the UK departs from the EU.


EMA: Brexit-related guidance for companies