The UK left the European Union on 31 January 2020 on the basis of the Withdrawal Agreement which was agreed by the European Council on 17 October 2019. The agreement includes a transition period until 31 December 2020.
Negotiations are ongoing between the EU and the UK on a new future relationship agreement which, if agreed, is due to come into effect from 1 January 2021. There is a possibility that no agreement on a future relationship is reached, effectively resulting in a ‘no deal Brexit’ on 1 January 2021. The HPRA is continuing operational planning and focussing our efforts on ‘no deal’ contingency planning.
The HPRA approach has been consistent with the work of the Commission and the EU human medicines, veterinary medicines and medical device networks calling on all stakeholders to ensure that they are prepared for every eventuality, including the worst-case scenario of a ‘no-deal’ Brexit. The guidance in this document is based on a potential ‘no-deal’ scenario. However, should the evolving political situation allow for the preparation of a more central case scenario, the document will be updated as appropriate.
Update: October 2020
This version of the HPRA’s Brexit Guidance document (see link above) has been updated to reflect the latest information from the EU Commission, including the updated notice to stakeholders (March 2020). It also includes updates and provides links to the latest information from the EMA, the CMDh (Co-ordination group for Mutual recognition and Decentralised procedures – human), and the CMDv (Co-ordination group for Mutual recognition and Decentralised procedures – veterinary).
Updates have been made to much of the content including the following sections:
- Multilingual packaging and joint labelling
- Post Brexit licensing scenarios for marketing authorisation holders
- Product testing for QP certification/release
A tracked changes version highlighting the main updates (compared to the April 2019 version) is also available.
The information provided in this latest version is based on our current understanding of the potential legal impact of the UK’s exit. However, it is important to note that guidance is evolving and may require updating as the negotiation process continues.
Update: April 2019
The previous version was updated to incorporate information in respect of batch testing rules and to reflect the latest European Commission Q&A. It also addresses queries raised at our Brexit stakeholder event on 1 February 2019. The guidance provided is based on our current understanding of the potential legal impact of an exit by the UK.
It is again important to note that guidance is evolving and must be agreed in respect of so-called ‘grey’ areas. Therefore, the advice currently provided may require updating as the negotiation process continues. In the event that a transition period is agreed, this guidance will be updated to reflect the terms of the transition.
Update: October 2018
The HPRA Brexit Guidance document has been updated to reflect the most recent information from the European Commission, European Medicines Agency and the Heads of Medicines Agencies.
There has been changes to the ordering of the information provided while links to external documents have also been updated to the most recent versions and inserted into the relevant sections.
Specific technical updates have been made to the following sections:
4 Availability of medicines
5 Joint labelling
6.4 Procedures for MAHs to transfer MAH to EU/EEA based MAH (including sub sections)
6.7 Medical devices containing an ancillary medicinal substance
6.8 Parallel Product Authorisations
9 Changes to import and export requirements (including sub sections)