In light of the pending withdrawal of the UK from the EU, we have published guidance in respect of the key issues facing the HPRA and our stakeholders. While there have been discussions at EU level on the introduction of transitional arrangements, the implementation and details of any transitional period will depend on the outcome of the Brexit negotiations.
It is highly likely that the advice currently provided may require updating throughout the negotiations process and during the lead up to Brexit. In addition, guidance is still being developed and must be agreed in respect of so-called ‘grey’ areas. Stakeholders are therefore advised to monitor our website on a regular basis to ensure they have access to the most up-to-date version of this document.
The information provided in our Brexit Guidance document is based on the premise that there will be a ‘no deal’ Brexit and the UK will become a third country by the withdrawal date.
Update: 26 April 2019
This version has been 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: 18 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)