UK ‘Needs To Be On EU’s API White List’ Post-Brexit
The UK pharmaceutical industry is concerned about potential barriers to trade that might arise with the EU post-Brexit, especially if co-operation mechanisms such as mutual recognition agreements are not in place by the time the UK leaves. API manufacturers have specific worries, but there won’t be answers for some time.
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The EU medicines network has issued a long list of changes that drug companies with activities in the UK will have to make if they are to continue to be located from a regulatory standpoint in the European Economic Area following Brexit. Aspects affected include the location of orphan designation holders, qualified persons for pharmacovigilance, companies’ manufacturing and batch release sites and maintenance of SME status.
The UK seemingly has no intention of imposing new regulatory requirements on life science companies after the country leaves the EU. That’s all well and good, but companies in the UK looking to continue doing business in the EU are worried they will face significant trade barriers post-Brexit. Everything will depend on the outcome of soon-to-start exit negotiations.
It wasn't quite an international incident, but this year's introduction of new EU rules for certifying the quality of imported active pharmaceutical ingredients (APIs) certainly ruffled many feathers among regulators in the world's major API supply markets.