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Batch testing announcement and review


Mark Samuels, Chief Executive of the British Generic Manufacturers Association (BGMA), said: "We welcome the Government’s decision to introduce a two-year notice period on potential changes to the current position of unilateral recognition of EU/EEA batch testing. It provides our industry with much-needed certainty in the short term.

“We also are pleased to hear a comprehensive review of the future batch testing strategy for the UK will be undertaken. As part of that, we will call for the current mutual recognition position to be adopted permanently. We have always been clear that any future relationship with the EU must include recognising regulatory processes that avoid the need for duplication that add time and cost. We must ensure that UK patients are not disadvantaged in any way in terms of future supply."