On May 2, the European Commission published a Notice to Marketing Authorisation Holders of Centrally Authorised Medicinal Products. The Notice seeks to alert pharmaceutical companies to the implications of Brexit and the need to take steps to avoid disruption in the supply of their products in the European Union.
In light of the United Kingdom's notification of its intention to withdraw from the EU, European legislation (treaties, regulations, directives, etc.) will cease to apply to the UK beginning on March 30, 2019, unless another date is set (in the withdrawal agreement or by the European Council).
Brexit will have important implications for companies holding so-called "Union marketing authorizations" (i.e., marketing authorizations granted by the European Commission and valid in all EU member states).
The Notice reminds those companies of the legal implications of Brexit, in particular those arising out of obligations with a territorial component, such as the obligation for the marketing authorization holder to be established in the EU (or in the European Economic Area) or to perform certain activities in the EU or EEA (for example, pharmacovigilance or batch release). Such companies will be required to relocate, as the UK will no longer be part of the EU.
The Commission also urges companies to prepare for the withdrawal sufficiently far in advance to avoid any impact on the continuous supply of their pharmaceutical products in the EU. Companies are advised to proactively screen their marketing authorizations to identify the necessary variations and transfers and to submit their variation and transfer requests in due time.
Going forward, the Commission and the European Medicines Agency will regularly provide updates with further practical information and relevant Q&As.
Brexit will also have important implications for companies holding national UK marketing authorizations. Information will be provided by the Coordination Group for Mutual Recognition and Decentralised Procedures - Human, a group of representatives of national agencies that oversee the pharmaceuticals industry.
Originally published May 4, 2017.
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