Handling of Active Substance Master Files and Certificates of Suitability

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the requirements for submitting Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs) for medicinal products. Following the UK’s departure from the European Union, the MHRA has established independent procedures, though it continues to follow the CHMP/QWP/227/02 Rev 4 guideline for ASMF compilation. Key requirements include the submission of the Applicant’s Part and the Restricted Part of the ASMF through the MHRA Submissions Portal. Submissions must be timed to coincide with Marketing Authorisation Applications (MAA) or Variations (MAV), ideally no more than one month prior to the application. The UK no longer participates in EU work-sharing or uses EU reference numbers. However, the MHRA may consider assessments from other recognized regulators under the International Recognition Procedure (IRP), provided the full assessment report is submitted. Regarding Certificates of Suitability, the process remains unchanged as they are issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM), of which the UK remains a member. Applicants must include current CEP copies in Modules 1 and 3 of their dossiers. ASMF holders are responsible for notifying both the MHRA and the marketing authorisation holders of any proposed changes to the files. These protocols ensure that active substances meet safety and quality standards within the UK regulatory framework.