European Medicines Agency identifies gaps in industry preparedness for Brexit

Published: Thursday, 12 July 2018 07:55

A recent European Medicines Agency (EMA) survey indicates that some companies need to step up efforts to ensure that medicine supplies in the UK and EU are not disrupted after Brexit.

Marketing authorisation holders for more than half (58 percent) of the 694 centrally authorised products (CAP) with an important step in their regulatory processes in the United Kingdom are on track with their regulatory planning to ensure that their marketing authorisation remains valid once the UK leaves the European Union. This leaves a substantial 42 percent who may not be as prepared as they need to be.

Regulatory authorities and marketing authorisation holders both play an important part in preparing for the consequences of Brexit to safeguard the continuous supply of human and veterinary medicines after the withdrawal of the UK from EU. Since May 2017, the European Commission and EMA have informed companies and raised their awareness of the need to put the necessary measures in motion. Information notices on legal issues and guidance on practical and simplified requirements for companies have been published and regularly updated.

The survey found that for 108 (88 human products and 20 veterinary products) medicines with manufacturing sites located in the UK only, there are serious concerns that the necessary actions will not be carried out in time.

EMA has analysed feedback from the survey and is now looking in detail at those medicines where there are risks of supply shortages and will assess how critical these are. As a regulator, EMA’s role is to ensure that it has a complete overview of the potential risks, and to work together with the relevant marketing authorisation holders to address these risks as early as possible and discuss relevant mitigation measures.

More information.