EMA Updates Q&A for Drugmakers Ahead of Brexit

June 21, 2018

The European Medicines Agency released updated guidance for drugmakers preparing for the UK’s exit from the European Union with new questions on topics such as how Brexit will impact the marketing of multi-country packs — medicinal products labeled to allow their placing on the market in several EU member states with the same packaging.

After Brexit, marketing authorization holders using multi-country packs that include the UK may need to modify their packaging, the agency said.

The guidance also addresses products that are subject to batch release and currently tested by a UK Official Medicines Control Laboratory. For products placed on the market as of the UK’s withdrawal date, batch release cannot be carried out by a laboratory located in the UK, the agency said.

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