HPRA Brexit Guidance - Human and Veterinary Medicines

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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.

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