Draft legislation amending the Human Medicines Regulations 2012 (2012 Regulations) and associated Medicines (Products for Human Use) (Fees) Regulations 2016 has been published to ensure they are fit for purpose in a no deal Brexit scenario. They allow the MHRA to function as a standalone regulator in the event of a no-deal Brexit. They also amend the 2012 Regulations to enable regulations to be made to temporarily modify the 2012 Regulations to deal with any serious shortages of medicines arising from the UK’s withdrawal from the EU. The draft legislation will now go to parliament for debate. Please see here for the full text.

Contingency legislation covering medical devices and clinical trials in a Brexit no deal scenario has also been pubished. Please see full text for Medical Devices here and for Clinical Trials here.

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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