EMA Answers Brexit Questions

The European Medicines Agency (EMA) announced on March 26, 2019 the publication of a question and answers (Q&A) document regarding the steps European Union authorities are doing to prevent drug shortages as a result of Brexit. The United Kingdom’s exit from the EU was expected to occur on March 29, 2019, but the UK government has asked for an extension. Because Brexit conditions are still unclear, EMA is advising pharma companies to prepare for all possible outcomes.

According to EMA, if there is a withdrawal agreement, medicines will not be affected because there will be a transition period in which EU law will continue to apply to the UK. In the event the UK leaves without a withdrawal agreement, however, EU law will no longer apply to the UK and companies may have to make changes to comply with EU law. EMA assures in the Q&A document that drug safety will not be affected by Brexit.

EMA states in the document that companies must transfer relevant operations from the UK to a EU/European Economic Area Member State or they may not be able to put drug products on the EU market until necessary changes are made. Guidance on how to transfer operations has been provided by the agency, and EU authorities will work with companies to get these changes made before the UK leaves the EU.

Source: EMA