In the event of a no-deal Brexit, the UK has said that it will automatically grant UK marketing authorization to drugs that already have a centralized EU approval after Brexit occurs on March 29 2019, the EU drug packaging deadline also falls on this date. However, this specific UK license will require a new marketing authorization number that must be placed on the outside of the drug packaging. The same rule applies to products that are currently being sold in the EU after being originally approved in the UK; they will require a new marketing authorization number to continue to be sold in the EU.
Fiona Barry, Associate Editor, PharmSource, a GlobalData Product, attending the recent Convention on Pharmaceutical Ingredients (CPhI) Worldwide conference in Madrid, commented on the situation: “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.
According to the GlobalData report ‘Brexit and the Healthcare Industry – Implications for Pharma, Q3 2018’, companies are already moving their marketing authorizations. The report surveyed pharmaceutical industry leaders within and outside the UK, and one UK Director’s company had moved EU Marketing Authorizations to a legal entity within the EU.