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European Medicines Agency publishes Brexit guidance for pharma companies

Jaclyn Jaeger | November 28, 2017

The European Medicines Agency this week published additional guidance for pharmaceutical companies to help them prepare for the United Kingdom’s withdrawal from the European Union.

The guidance document outlines the practical and simplified requirements that companies should follow when they apply for changes to their marketing authorisation to allow for the continued marketing of their medicine in the European Economic Area after the United Kingdom withdraws from the EU. The guidance has been prepared on the basis that the United Kingdom will become a third country as of 30 March 2019.

The newly released additional guidance, which relates to medicines for human and veterinary use, should be read in...

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