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Change And More Change: That’s What Brexit Means For Drug Companies

 
• By Vibha Sharma
  
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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.

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Brexit Means Large-Scale Change For Companies • Source: Shutterstock

EU drug companies that have some or all of their activities based in the UK have been asked to consider changes on almost every front – from manufacturing of active substances and finished products, to undertaking batch release, to maintaining their product’s orphan designation and the company’s SME status – to ensure their establishments remain on the correct side of the EU law following Brexit.

The latest advice comes in the form of two question and answer documents, issued by the European Medicines Agency and...

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