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Response to government’s publication of technical notices on plans to regulate medicines in the event of a no-deal Brexit

In response to the Government’s publication of technical notices setting out how they plan to regulate medicines in the event of a no-deal Brexit, Warwick Smith, Director General of the British Generic Manufacturers Association (BGMA) and the British Biosimilars Association (BBA), said: “We welcome the three technical notices that the Government has published today and which impact directly on generic and biosimilar medicines manufacturers. We all want an agreement between the UK and the EU27 on a future relationship which protects the benefits for patients of the European single market in medicines and regulatory framework which allows our complex cross-border supply chains to continue to function effectively.

“But lead times in the manufacture of medicines last many months, and industry needed to know now how the UK Government would oversee regulation if we were to leave the EU without a transition period or other arrangement. We have been discussing what is needed with the Government for some time: these notices build on past ministerial commitments and are a tangible expression of the pragmatic approach that we understood they would take. We particularly welcome the Government’s commitment to accept batch testing and release in the EU. Further detail is needed on some issues, such as the approval of biological medicines, and we welcome the Government’s commitment to consult industry further on these outstanding issues.

“But what we have today already gives industry much more of the certainty that we need and we welcome the realistic and pragmatic approach that the Government is taking.”