TMC Pharma Services has received confirmation from the Medicines and Healthcare products Regulatory Agency (MHRA) that our recent application, made on behalf of one of our longstanding clients, for a Great Britain Marketing Authorisation (MA) under the MHRA’s new European Commission Decision Reliance Procedure (ECDRP) has been successfully validated.
The ECDRP came into effect on 1 January 2021 and enables the MHRA to rely on a decision taken by the European Commission (EC) on the approval of a new MA in the centralised procedure. The MHRA aims to determine the Great Britain MA within 67 days and as soon as possible after EC approval.
TMC is proud to have been involved in this submission and looks forward to working with the MHRA toward approval.