A draft Withdrawal Agreement between the EU and the U.K. has been published by the European Commission (28/02/2018), which puts the agreement on Phase 1 of Brexit negotiations reached in December into a legal document.

In this agreement, the U.K. is required to “make available without delay” the marketing authorisation application of a drug approved by the U.K. competent authorities before the end of the Brexit transition period, if an EU Member State or the European Medicines Agency requires it.

U.K. notified bodies should also provide information to other EU countries about their certification activities until the end of the transition period, should a certificate holder require it (e.g. a medical device manufacturer). Notified bodies in the EU are also required to do the same for the U.K.

The agreement also says that EU rules would still apply if a new application for a supplementary protection certificate (for drugmakers and pesticide manufacturers) or for an extension was made before December 31, 2020 – the end of the transitioning period.

The agreement also says that the U.K. will lose access to any EU network, database and information system after the transition period. This is expected to include the EU Early Warning and Response System which monitors public health threats and also the Rapid Alert System for Food and Feed which sends alerts about potential threats detected in the food supply. This may also affect access to EudraVigilance, the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area.

For further information please contact Julia Gillert of our London office or Els Janssens of our Abu Dhabi office.

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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