The EMA and the U.K. after Brexit

As the European Union (EU)-based European Medicines Agency (EMA) announced recently, the United Kingdom formally left the European Union (the process colloquially referred to as Brexit) at the end of January 2020 and will become a third country to the EU. Up to this point, the United Kingdom has been a central part of the EMA, hosting its headquarters, though that honor is now shifting to Amsterdam in the Netherlands.

A transition period began Feb. 1 and is due to end on the last day of this year. During the transition period, EU pharmaceutical law as laid out in the “Acquis Communautaire” will continue to be applicable to U.K. operations, meaning that pharmaceutical companies can continue to carry out activities in the United Kingdom until the end of the year.

Companies have until the end of December to make the necessary changes to ensure that their authorized medicines comply with EU law and can remain on the EU market. Marketing authorization holders and applicants can still be established in the United Kingdom, and qualified persons for pharmacovigilance and pharmacovigilance system master files, as well as quality control testing sites, can still be based in the country until the end of 2020.

Updated Brexit-related guidance for companies will be published shortly.

The withdrawal agreement foresees that following its departure from the EU, the United Kindgom will no longer participate in EU institutions and their decision-making. For the EMA, this means that as of Feb. 1, no one who represents the United Kingdom, or is appointed or nominated by the country, can participate in meetings of EMA’s scientific committees, working parties or the agency’s management board.

Noted the EMA in their announcement: “The agency would like to thank all U.K. delegates and experts for their involvement in the scientific and regulatory activities of EMA since its establishment 25 years ago. Their professionalism and commitment have contributed greatly to the development and functioning of the strong and efficient system for medicines regulation that we have in the EU today.”