Handling of Active Substance Master Files (ASMF) and Certificates of Suitability from 1 January 2021

The UK will no longer participate in ASMF work-sharing procedures with EU Member States. From 1 January 2021, the MHRA will continue to accept an Active Substance Master File.

Where an assessment of a new ASMF or an update to an ASMF has been conducted by an EU Member State before 1 January 2021, such an assessment may be taken into consideration in subsequent MAA or MAV applications. There will be no change to the procedures relating to the use of a CEP to support an MAA or MAV.

It is our intention to update these regulations to reflect the change of implementation dates following the transition period.

Source: MHRA guideline on Handling of Active Substance Master Files and Certificates of Suitability from 1 January 2021