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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)

础苍听ASMF听should 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鈥檚 Part (AP) of the听ASMF听as part of the听MA听dossier, together with a letter of access issued by the听ASMF听丑辞濒诲别谤.

When an听ASMF听procedure is to be used which relates to an听ASMF听that has not previously been submitted to the MHRA, the听ASMF听holder should submit a copy of the听AP听and 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 the听AP听and for the听RP
• a curriculum vitae for the Expert

The complete听ASMF听only needs to be submitted once to register the听ASMF听with the MHRA. The relevant documentation should be timed to arrive at approximately the same time as the听MAA听辞谤听MAV, so not more than one month before and not after the intended听MAA/MAV听submission date.

Changes to an听ASMF听should be handled in accordance with the CHMP guideline (). The听ASMF听holder needs to fulfil their responsibilities with respect to notifying each Applicant/MA听holder and the MHRA, that changes are being proposed to the听ASMF.

Submission of a new听ASMF听and any update to an听ASMF听should be made by the听ASMF听holder using the MHRA听Submissions Portal.

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

Where an assessment of a new听ASMF听or an update to an听ASMF听has been conducted by another regulator such an assessment may be taken into consideration in subsequent听MAA听辞谤听MAV听applications 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鈥檚 part and the restricted part is required to be submitted in support of application. 听Please refer to MHRA guidance on the IRP: International Recognition Procedure - 伊人直播 (www.gov.uk)

3. Certificates of Suitability (CEPs)

CEPs听are not affected by the UK no longer being a Member State of EU as they are issued by the听. 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 the听MAA听辞谤听MAV听application 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 at听RIS.NA@mhra.gov.uk or call 020 3080 6000.