EMA publish Q&A document: EU actions to prevent medicine shortages due to Brexit

The European Medicines Agency (EMA) has published a questions-and-answers (Q&A) document for patients, healthcare professionals and the general public on the preparatory work that European Union authorities are doing to prevent medicine shortages due to the United Kingdom’s withdrawal from the EU.

It explains that in case of a withdrawal agreement, there will be a transition period during which EU law will continue to apply in the United Kingdom. This means that access to medicines will not be affected.

If the UK leaves without a withdrawal agreement or deal (‘no-deal scenario’), 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.

The Q&As explain how 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, if the UK leaves the EU without a withdrawal agreement.

The document underlines that Brexit will not impact the safety of medicines, nor the way they are evaluated. EMA and the Member States will continue to monitor the safety and efficacy of medicines without any changes.

This document applies to both human and veterinary medicines and will be updated as necessary.

Industry preparations for new Brexit deadlines

In view of the conclusion of the European Council on 22 March to extend the date of the withdrawal of the UK from the EU, EMA calls on all pharmaceutical companies in the EU to continue their preparedness activities, taking into account all possible outcomes. Based on the European Council conclusions, the deadline of 29 March referred to in EMA’s published Brexit-related guidance should be understood to be replaced by 12 April 2019 until further notice.

Further information is available by clicking here.

For more information on the European regulatory system for medicines, please click here (brochure available in all languages).

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