Update: European Council adopts decision extending the period under 'Article 50'
The European Council agreed to a further extension of the date for the UK’s withdrawal from the EU at its meeting on 10-11 April. The extension will last as long as necessary and, in any event, no longer than 31 October 2019. For more information, see:
- European Council decision taken in agreement with the United Kingdom, extending the period under Article 50(3)TEU
- European Commission: Brexit preparedness activities
The UK remains a Member State for the duration of the extension, with all the rights and obligations set out in the treaties and under EU law.
All pharmaceutical companies in the EU are reminded to continue their preparedness for the UK’s withdrawal.
Based on the European Council decision, the deadline of 29 March 2019 referred to in Brexit related guidance should be understood as referring to 31 October 2019.
If the UK fails to hold European Parliament elections, it will leave the EU on 1 June 2019 and the deadline should be understood as 31 May 2019.
- Template for Notification of request for a time-limited exemption to continue batch control testing in the United Kingdom (UK) after UK’s withdrawal from the Union for a nationally authorised medicinal product (February 2019)
Contact points for requests for exemption to continue batch control testing in the United Kingdom (UK) after UK’s withdrawal from the Union for a nationally authorised medicinal product (February 2019)
- National information on MAH transfers (January 2019)