The European Medicines Agency has updated its suite of guidance on Brexit. The guidance is written from the premise that the UK will leave the EU on 29 March 2019 without a deal in place. This follows the recent publication by the UK’s MHRA of substantive no-deal guidance and draft legislation to put no-deal measures into effect in such circumstances.
Guidance on marketing authorisations granted through the centralised procedure is updated, and reiterates the importance of ensuring that any centrally authorised MAs (CAPs) held by UK entities must be moved to entities based in the EU-27 by the point of a no-deal Brexit.
There is updated guidance in relation to drugs being evaluated through the mutual recognition and decentralised procedures. This covers the issue of still ongoing or pending applications and gives clarity on how to handle these. Any variations still pending with the UK as RMS will be stopped at the point of Brexit, and will require the RMS to be transferred to the EU-27 before any other variations can be made, post-Brexit.