• By ICR Secretariat
  • Posted Thursday, May 4, 2017

EMA Publishes Brexit Guidance Section of Their Website

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/general/general_content_001707.jsp&mid=WC0b01ac0580a809a7

The EMA have published guidance for marketing authorisation holders over how Brexit will affect their responsibilities. Particularly, they remind companies that marketing authorisation holders must be based in the EU, and by 29th March 2019, the UK will count as a 3rd country. In addition, certain activities must take place inside the EU, for example pharmacovigilance. Again, companies that do any business in Britain will have to 'prepare and proactively screen authorisations they hold for the need for any changes. The necessary transfer or variation requests will need to be submitted in due time considering the procedural timelines foreseen in the regulatory framework.'

 

For more information, you can view the notice here. They will also be updating this page with future guidance, as and when it is published.