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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)

´¡²ÔÌýASMFÌýshould be prepared in accordance with the Committee for Medicinal Products for Human Use (CHMP) guideline on active substance master file procedure ().

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 Applicant’s Part (AP) of theÌýASMFÌýas part of theÌýMAÌýdossier, together with a letter of access issued by theÌýASMFÌý³ó´Ç±ô»å±ð°ù.

When anÌýASMFÌýprocedure is to be used which relates to anÌýASMFÌýthat has not previously been submitted to the MHRA, theÌýASMFÌýholder should submit a copy of theÌýAPÌýand 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 theÌýAPÌýand for theÌýRP
• a curriculum vitae for the Expert

The completeÌýASMFÌýonly needs to be submitted once to register theÌýASMFÌýwith the MHRA. The relevant documentation should be timed to arrive at approximately the same time as theÌýMAAÌý´Ç°ùÌýMAV, so not more than one month before and not after the intendedÌýMAA/MAVÌýsubmission date.

Changes to anÌýASMFÌýshould be handled in accordance with the CHMP guideline (). TheÌýASMFÌýholder needs to fulfil their responsibilities with respect to notifying each Applicant/MAÌýholder and the MHRA, that changes are being proposed to theÌýASMF.

Submission of a newÌýASMFÌýand any update to anÌýASMFÌýshould be made by theÌýASMFÌýholder using the MHRAÌýSubmissions Portal.

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

Where an assessment of a newÌýASMFÌýor an update to anÌýASMFÌýhas been conducted by another regulator such an assessment may be taken into consideration in subsequentÌýMAAÌý´Ç°ùÌýMAVÌýapplications 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 applicant’s part and the restricted part is required to be submitted in support of application. ÌýPlease refer to MHRA guidance on the IRP: International Recognition Procedure - °Ç¸ç³Ô¹Ï (www.gov.uk)

3. Certificates of Suitability (CEPs)

CEPsÌýare not affected by the UK no longer being a Member State of EU as they are issued by theÌý. 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 theÌýMAAÌý´Ç°ùÌýMAVÌýapplication 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 atÌýRIS.NA@mhra.gov.uk or call 020 3080 6000.