The European Medicines Agency (EMA) and the European Commission have updated their guidance which will help pharmaceutical companies prepare for the UK’s withdrawal from the European Union (EU).
The new questions and answers document for pharmaceutical companies includes information on how Brexit will affect the status of inspection outcomes by the UK national competent authority and batch release processes for medicines that are subject to Official Control Authority Batch Release (OCABR) and Official Batch Protocol Review (OBPR).
It also clarifies how scientific opinions of the Committee for Medicinal Products for Human Use (CHMP) for ancillary medicinal substances in medical devices requested by UK notified bodies will be affected.
What new information is in the publication?
Additionally, the updated document includes new information on back-up arrangements for Qualified Persons for Pharmacovigilance (QPPV) and on marketing multi-country packs of medicines, where one of the countries in which the packs will be sold includes the UK.
The EMA has also published an updated version of its practical guidance for industry which outlines the steps that companies should follow in order to make sure that necessary changes to their marketing of medicines are made by the end of March 2019, to allow marketing for their medicine to continue in the EU once Brexit is initiated.
What’s next for pharmaceutical companies?
To avoid any impact on the continuous supply of medicines for both human and veterinary use within the EU, companies are being reminded to plan for the UK’s withdrawal from the EU on 29 March 2019.
Companies are advised to continually monitor the EMA webpage dedicated to the consequences of the UK’s withdrawal from the EU.
For a piece in the Financial Times, the UK head of Pifizer, Erik Nordkamp, wrote: “The UK pharmaceutical industry and the patients who rely on it are under serious threat from Brexit as well as from the flawed way medicines are developed, tested and made available to patients in the country.”