IPEC e-newsletter - Excipients Insight December 2017 - 18-12-17


Inside this issue


EMA publishes guidance to help pharma companies prepare for Brexit

The European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies prepare for the UK’s withdrawal from the EU.

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 (EEA) after the UK withdraws from the EU.

The guidance has been prepared on the basis that the UK will become a third country as of 30 March 2019, says the EMA. It should be read in conjunction with an associated questions and answers document.




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