EMA updates Brexit Q&A and practical guidance documents

The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) exit from the European Union (EU).

The two guidance documents provide questions and answers, and practical advice for marketing authorisation holders (MAH) who will need to make Brexit-related transitions and adjustments for their centrally authorised products to ensure that they are in compliance with EU requirements once the UK leaves the EU.

All updates to the questions-and-answers (Q&A) document are marked with ‘NEW’ and include information on how the UK’s withdrawal will affect the status of inspection outcomes by the UK national competent authority and batch release processes for medicines that are subject to the Official Control Authority Batch Release (OCABR) and Official Batch Protocol Review (OBPR). The document clarifies how scientific opinion 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. Furthermore, the Q&A includes new information on the back-up arrangements for Qualified Persons for Pharmacovigilance (QPPVs) 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 details the steps that companies should follow to ensure that necessary changes to their marketing authorisation are made by the end of March 2019, to enable continued marketing of their medicine in the Union after Brexit.  EMA has added 14 new questions, including who companies should contact at the EMA with Brexit-related inquiries; how to consider national scientific advice from UK competent authorities and how to transfer orphan designations from UK-based sponsors to ones based in the European Economic Area.

The EMA have reminded companies to plan for the UK’s withdrawal from the EU on 29th March 2019 in order to avoid any impact on the continuous supply of medicines within the EU and are advised to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU.

To view the EMA guidance documents which aim to help pharmaceutical companies prepare for the UK’s withdrawal from the EU, please click here.