EMA has published a Q&A document to answer Brexit questions

brexit

EMA has published a Q&A document to answer Brexit questions

In order to prevent medicine shortages due to the United Kingdom’s withdrawal from the EU (Brexit), EMA has published a questions-and-answers document for patients, healthcare professionals and the general public.

This Q&A document clarify that if a withdrawal agreement is endorsed and enters into force, the access to medicines will not be affected because there will be a transition period during which EU law will continue to apply in the UK. If there is no deal and the UK leaves without a withdrawal agreement, EU law will cease to apply in the UK. In this case, in order to be able to continue to supply medicines in the EU, companies carrying out certain activities in the UK will need to make changes to comply with EU law.

EMA recommend 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 medicines on the EU market until necessary changes are made.

According the document, EMA, the European Commission and EU/EEA Member States have been working closely together since May 2017 to advise companies on how to apply for the necessary changes in order to minimise the impact on the supply of medicines, in case of “no-deal scenario”.

EMA assures that Brexit will not impact the safety of medicines, nor the way they are evaluated. The Q&A document applies to both human and veterinary medicines.

If you need any support or have any further question, please contact us at [email protected]

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