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.

Author

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

Author

Els Janssens is a senior associate in our Abu Dhabi office and provides knowledge management support to Baker & McKenzie’s global and MENA Pharmaceutical and Healthcare industry group. Els started her career in 2000 at Baker and McKenzie in Brussels focusing her practice on pharmaceutical law and commercial litigation. She has worked six years in London as a legal adviser with the European Medicines Agency (EMA). During this period she has supported the EMA’s activities in medicines oversight and regulation and interacted with the European Commission on legal matters relating to medicinal products. She also worked one year as senior legal counsel in Johnson & Johnson’s European legal department providing regulatory advice regarding various medicinal products and supporting the public affairs function on new legislation.

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