GovWire

1. Overview

The MHRA accepts Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs). This document summarises the ASMF compilation and submission process.

2. Active Substance Master File (ASMF)

AnASMFshould be prepared in accordance with the Committee for Medicinal Products for Human Use (CHMP) guideline on active substance master file procedure (CHMP/QWP/227/02 Rev 4).

Templates (letter of access; submission letter and administrative details form) included in the annexes to that guideline should continue to be used.

An applicant should submit the Applicants Part (AP) of theASMFas part of theMAdossier, together with a letter of access issued by theASMFholder.

When anASMFprocedure is to be used which relates to anASMFthat has not previously been submitted to the MHRA, theASMFholder should submit a copy of theAPand Restricted Part (RP) to the MHRA. This should be accompanied by:

• a completed submission letter and administrative details form
• any relevant letter of access
• the Quality Overall Summary for theAPand for theRP
• a curriculum vitae for the Expert

The completeASMFonly needs to be submitted once to register theASMFwith the MHRA. The relevant documentation should be timed to arrive at approximately the same time as theMAAorMAV, so not more than one month before and not after the intendedMAA/MAVsubmission date.

Changes to anASMFshould be handled in accordance with the CHMP guideline (CHMP/QWP/227/02 Rev 4). TheASMFholder needs to fulfil their responsibilities with respect to notifying each Applicant/MAholder and the MHRA, that changes are being proposed to theASMF.

Submission of a newASMFand any update to anASMFshould be made by theASMFholder using the MHRASubmissions Portal.

The UK no longer participates inASMFwork sharing procedures with EU Member States. Any reference in the above guideline to theCTSASMFassessment repository or to EU/ASMF/XXXXX reference numbers has not been applicable to UK national applications since 1 January 2021.

Where an assessment of a newASMFor an update to anASMFhas been conducted by another regulator such an assessment may be taken into consideration in subsequentMAAorMAVapplications if they are submitted through the MHRA International Recognition Procedure (IRP) using one of the listed Reference Regulators (RRs). In that case the assessment report of the RR on both the applicants part and the restricted part is required to be submitted in support of application. Please refer to MHRA guidance on the IRP: International Recognition Procedure - GOV.UK (www.gov.uk)

3. Certificates of Suitability (CEPs)

CEPsare not affected by the UK no longer being a Member State of EU as they are issued by theEuropean Directorate for the Quality of Medicines and Healthcare (EDQM). This is a Directorate of the Council of Europe and a body that is independent of the EU. The UK remains a member of the Council of Europe and a signatory to the Convention on the Elaboration of a European Pharmacopoeia.

3.1 Marketing authorisation applicants

• Should include appropriate information in theMAAorMAVapplication form.
• Should include a copy of the current version of the relevant CEP in Modules 1 and 3.

The second of these actions relates to applications where there is:

• a CEP for a chemical substance that is an active substance or excipient;
• a CEP for a herbal drug or herbal drug preparation
• a CEP for materials of animal or human origin that have been subject to an evaluation of the risk related to transmissible spongiform encephalopathies (TSE).

4. Further information

For further information, please email our Customer Services Centre atRIS.NA@mhra.gov.uk or call 020 3080 6000.