On 29 March 2017 the United Kingdom (UK) notified the European Union (EU) of its intention to withdraw from the EU (‘Brexit’). According to Article 50 of the Treaty on the European Union, the UK was due to leave the EU by 29 March 2019. However, the withdrawal was postponed twice following the European Council’s agreement with the UK’s requests for an extension.1
The conditions under which the UK will leave the EU are currently unclear.
If a withdrawal agreement is endorsed and enters into force, there will be a transition period during which EU law will continue to apply in the UK. This means that access to medicines will not be affected.
If instead, 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 some medicines in the EU, companies carrying out certain activities in the UK will need to make changes to comply with EU law.
EMA, the European Commission (EC) and EU/EEA2 Member States have been working closely together since May 2017 to advise companies on how to apply for the necessary changes and have encouraged industry to plan well in advance and to implement such changes before Brexit.3 The objective of this work is to minimise the impact on the supply of medicines if the UK leaves the EU without a withdrawal agreement.
This Q&A applies to both human and veterinary medicines and will be updated as necessary…