UK calls for mutual recognition of GMP certificates in Brexit negotiations

After the end of the Brexit transition period, UK officials are seeking provisions to facilitate trade in medicinal products between the UK and EU, proposing that each side recognise good manufacturing practice (GMP) certificated issues by each other.In a document outlining its approach, the UK government details multiple specific objectives including an annex on medicinal products (annex 18 pg 7). This will theoretically help to enhance cross-border trade and “support high levels of patient safety.”

As well as GMP certificates, they also want to agree mutual recognition of batch testing certificates, aligning with the Comprehensive Economic and Trade Agreement between the EU and Canada (CETA). The EU’s existing relationships with other countries such as Switzerland and the US are also cited in the document, with which the UK hopes to align sharing of confidential information and pharmacovigilance.

Currently this annex only covers medicines but has the potential for extension to other biological medicines, vaccines and clinical trials. The government continues to promote the benefits of leaving the EU, starting with a debate on the newly introduced Medicines and Medical Devices Bill.