EMA Identifies Gaps in Brexit Preparedness of Industry

The European Medicines Agency EMA expresses “serious concerns” over the preparedness of some marketing authorisation holders for centrally authorised products with an important step in their regulatory processes in the United Kingdom (UK) regarding the necessary actions to smoothly transition once the UK will exit the EU in March 2019. This...
The European Medicines Agency EMA expresses “serious concerns” over the preparedness of some marketing authorisation holders for centrally authorised products with an important step in their regulatory processes in the United Kingdom (UK) regarding the necessary actions to smoothly transition once the UK will exit the EU in March 2019. This conclusion was drawn after evaluating the results of an industry survey which was initiated by the Agency in January 2018 (we reported).

The results of the EMA survey on Brexit preparedness show that

  • 58 % of all marketing authorisation holders are on track with their regulatory planning to ensure that their marketing authorisation remains valid once the UK leaves the European Union (EU).
  • For 16 %, of the medicines with manufacturing sites located in the UK only, there are serious concerns that the necessary actions will not be carried out in time.
  • For 10 % of the products included in the survey, EMA received no feedback from companies.

EMA is liaising directly with the marketing authorisation holders of those 26 % of products who either did not reply to the survey or have indicated in the survey that they do not plan to submit the changes required by 30 March 2019 and have manufacturing sites in the UK only.

The Agency urges those companies who have not yet informed EMA of their Brexit preparedness plans to do so as soon as possible to mitigate any risks to the continuous supply of medicines for human and veterinary use within the EU.

Source: www.gmp-publishing.com