UK clarifies post-BREXIT batch testing rules for pharmaceuticals 

Batch testing pharmaceuticals

The UK government has announced its future strategy for batch testing of medicinal products. 

The new strategy means that the UK will continue to recognise batch testing from the EU/EEA, rather than insisting on duplicative batch testing operations. 

Post-BREXIT, the pharmaceutical industry urged the UK and the EU to sign a Mutual Recognition Agreement (MRA) for inspections, batch release and testing.  

Both sides agreed to mutually recognise inspections but did not agree to mutually recognise batch testing, which led to confusion for the industry. 

To support companies during the pandemic, the UK unilaterally waived batch testing requirements for products coming from the EU for two years, including for Covid-19 vaccines. 

The Association of the British Pharmaceutical Industry (ABPI) has welcomed the decision. Richard Torbett, ABPI Chief Executive said: “This important decision gives much needed regulatory clarity to pharmaceutical companies in the UK. The government has listened to evidence from the ABPI and from across the life sciences sector to agree a pragmatic approach which will eliminate duplicative testing requirements.”

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