Pharma companies warned of packaging obligations in the event of a no-deal Brexit

4 December 2018

Many European Union and US pharma companies are unaware that if a no-deal Brexit is reached between the UK and the EU, they will need to meet a crucial EU export administration deadline by March 29, 2019, a regulatory expert has confirmed.

Fiona Barry, associate editor, PharmSource, a GlobalData product, attending the recent Convention on Pharmaceutical Ingredients (CPhI) Worldwide conference in Madrid, Spin, commented: “It was interesting to speak to Lynne Byers, executive director of NSF International’s pharma biotech services, who summarized that if drug makers change their drug’s batch release site or have to reapply for a marketing authorization, they will need to repackage their drug, making this Brexit’s biggest and currently least understood impact on pharma companies.”

Currently, new drugs are approved in the EU by a mutual recognition procedure (MRP) whereby a single EU country assesses the product and awards a marketing authorization, which then holds for all EU countries.

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