Extension of the period under 'Article 50'
Update: On 29 October 2019, the European Council agreed to a further extension of the date for the UK’s withdrawal from the EU. The extension will last as long as necessary and, in any event, no longer than 31 January 2020. For more information, see:
- European Council decision taken in agreement with the United Kingdom, extending the period under Article 50(3) TEU (28/10/2019)
- European Commission: Brexit preparedness activities
The UK remains a Member State for the duration of the extension.
All pharmaceutical companies in the EU are reminded to continue their preparedness for the UK’s withdrawal.
Based on the European Council decision, and until further notice, the deadline of 29 March 2019 referred to in Brexit related guidance should be understood as referring to 31 January 2020.
Exemption for batch testing of medicines in UK
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
- National information on MAH transfers (January 2019)