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.
As a result, the guidance provided in this document is based on the premise that there will be a hard Brexit and the UK will become a third country by 30 March 2019. It is also based on our current understanding of the potential legal impact of an exit by the UK.
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.
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)