EMA identifies gaps in industry preparedness for Brexit

EMA

10 July 2018 - Survey indicates that some companies need to step up efforts to ensure medicine supply in the EU.

A recent EMA survey shows that marketing authorisation holders for more than half (58%) of the 694 centrally authorised products with an important step in their regulatory processes in the United Kingdom (UK), are on track with their regulatory planning to ensure that their marketing authorisation remains valid once the UK leaves the European Union (EU).

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.

Read EMA press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

England , Medicine , Regulation , Brexit