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Brexit’s impact on the European Medicines Agency and notice to Marketing Authorisation Holders

Brexit’s impact on the European Medicines Agency and notice to Marketing Authorisation Holders
May 5, 2017 boydsads17

Following the UK’s decision to withdraw from the European Union, the European Medicines Agency (EMA) has been considering the implications for its location and operations.

As no member state has left the EU before, there is no precedent for the situation the EMA finds itself in.

What is clear though is that the EMA, will continue to focus on its mission to protect human and animal health and ensure access to medicines that are safe, effective and of good quality.

On 2 May 2017, the EMA and the European Commission published a notice to marketing authorisation holders of centrally authorised medicinal products for human veterinary use.

This notice states that marketing authorisation holders of centrally authorised medicinal products need to consider certain legal repercussions, and need to act sufficiently in advance to avoid any impact on the continuous supply of medicines for human and veterinary use within the EU.

In April 2017, the EMA started discussions with the authorities on how work related to the evaluation and monitoring of medicines will be shared between Member States in view of the UK’s withdrawal from the EU. This is currently based on the scenario that the UK will no longer be a member of EMA and the European Regulatory Network from 30thMarch 2019.

Location

At the moment, the location of the EMA post Brexit is unknown, with a complex political and legal environment to contend with, the member states will work to make the most appropriate decision.

The team at Boyds will be following this closely and will share updates as things develop. For more information, click here.