Update: 25 July 2019

Exemption for batch testing of medicines in UK

Following a request by the United Kingdom, the European Council (Article 50) agreed on 11 April 2019 to extend further the period provided for in Article 50(3) TEU until 31 October 2019. Unless the United Kingdom ratifies the Withdrawal Agreement by 31 October 2019 or requests a third extension, to which the European Council (Article 50) agrees by unanimity, the period under Article 50(3) TEU will end then. The United Kingdom will then be a third country as of 1 November 2019.

On 21 February 2019 Commission services set out in a note on the “Withdrawal of the United Kingdom and EU rules for batch testing of medicinal products”, the conditions for marketing authorisation holders to continue relying on quality control testing performed in the United Kingdom for a limited period of time after the UK becomes a third country. A key condition for this exemption is that “all necessary steps have been taken to prepare the transfer of the quality control testing site to the EU27”. Furthermore, “marketing authorisation holders must confirm and set out their precise timetable for transfer of the quality control testing site (which should allow the process to be completed quickly and in principle by the end of 2019 at the latest)”.

It is essential that marketing authorisation holders use the remaining time to complete their preparations so that by 1 January 2020 all batch testing facilities are fully transferred to the EU27/EEA and the necessary regulatory submissions are completed.

For further details please see the relevant communication: https://ec.europa.eu/health/sites/health/files/files/documents/brexit_batchtesting_medicinalproducts_en.pdf

 


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:
 

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.