The European Medicines Agency published on May 31, 2017 its first set of questions and answers (Q&A) aimed at guiding European marketing authorization holders of medicines about the consequences of Brexit.
The Q&A assumes that no agreement will be reached between Britain and the EU on pharmaceutical regulation. In such a scenario, indeed, marketing authorisation holders would potentially need to act sufficiently in advance of March 30, 2019 (or any other date as determined in the withdrawal agreement or agreed by the European Council) to avoid any impact on the continuous supply of medicines for human and veterinary use within the European Union and the UK.
In the Q&A, the Agency reminds companies that under the EU regulations the marketing authorization holder, orphan drug sponsor, company with MUMS (Minor Use Minor Species) status for its veterinary medicinal product, need to be located in the EU. This means that if the marketing authorization holder of centrally authorized products is located in the UK, that marketing authorization would need to be transferred to a holder located in the EU. The same applies for the sponsor of orphan drug designations and a company with MUMS status for its products.
The Q&A also makes clear that the qualified person for pharmacovigilance and the pharmacovigilance master file need to be based in the EU and the location of the pharmacovigilance master file will determine which supervisory authority will have oversight. Companies with an EU QPPV and PSMF based in the UK would need to consider moving those in time or in the case of the QPPV to appoint another who resides and can carry out his or her tasks in the EU.
After March 30, 2019, medicinal products manufactured in the UK for the EU market would need to be imported into the EU and this could be subject to an authorization by the competent authorities in the Member States. Companies are reminded that in such case an authorized importer would need to be appointed and a site for batch control in the EU will be necessary.
Where the guidance refers to the Union for its establishment requirements, this should be read as to include EEA Member States (Norway, Iceland and Liechtenstein).
In response to the Agency’s publication of the Q&A, the UK’s trade association, the ABPI, has been critical, warning that the Q&A poses a risk to UK pharma jobs and public health, and would cost “hundreds of millions of pounds” should companies follow it. The UK’s Financial Times reports that Dr Virginia Acha, executive director of research, medical and innovation at the ABPI said that Brexit negotiations had yet to start and that “it seems premature to advise companies to prepare only for an outcome where the UK is isolated from the European system”.
Implementing the necessary changes to continue to meet regulatory requirements would require careful consideration against the uncertainties, with the potential to trigger tax, IP, and employment issues, amongst others. BakerMcKenzie continues to advise a wide range of clients on dealing with Brexit including pharmaceutical companies.
For further information and to be put in touch with the right adviser for your needs, please contact Julia Gillert (Senior Associate, Healthcare) of our London office or Els Janssens (Global Professional Support Lawyer, Healthcare) of our Abu Dhabi office.
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.
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.