Draft EMEA Note for Guidance on DMF Procedures

GMP News No. 224

GMP News
23 August 2002
 

Draft EMEA Note for Guidance on DMF Procedures

 
Is the CEP becoming mandatory for existing active substances described in the European Pharmacopoeia - CEP also for Herbal Medicinal Products?

The revised Note for Guidance on the European Drug Master File Procedure (Draft, February 2002, 1) is intended to help applicants for human and veterinary medicinal products, when using the Drug Master File (DMF) procedure for active substances in the preparation of a dossier for an application to a marketing authorisation of a medicinal product – including line extensions – or in the preparation of a dossier for an application for a variation of the Marketing Authorisation of a medicinal product.

According to this NfG there are 4 types of active substances possible:

  • New active substances
  • Existing active substances described in the European Pharmacopoeia
  • Existing active substances not described in the European Pharmacopoeia, but described in the pharmacopoeia of a Member State
  • Existing active substances, not described in the European Pharmacopoeia or the pharmacopoeia of a Member State
  • For type A, C and D the DMF procedure may be used. The draft revision of the NfG proposes to make the CEP procedure (2) mandatory for those existing active substances described in the European Pharmacopoeia (Type B). But – as mentioned in the introductory part of the draft revision – the transition will require a change in legislation. In this draft revision it is also stressed that in the event that a CEP is not yet available, the applicant should require his API supplier to seek a CEP at the EDQM.

    With regard to the CEP-Procedure there is another interesting news:
    The newly established HMPWP (Herbal Medicinal Products Working Party) met for the first time on 11-12 March 2002 at the EMEA in London, UK. The major objective of this working party is to facilitate mutual recognition of marketing authorisations for herbal medicinal products and minimise the need to invoke the CPMP arbitration procedure. One of the topics of this meeting was a report that was presented by the European Pharmacopoeia where proposals for the extension of the Certification procedure to herbal drugs and preparations were discussed (3).

    If you are interested in hearing more about the DMF and CEP Procedure, we recommend you to visit the 5th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients.

    Abbreviations:
    EDQM = European Directorate of Quality of Medicines
    HMPWP = Herbal Medicinal Products Working Group
    MA = Marketing Authorisation
    MS = Member State
    NfG = Note for Guidance

    Literature:
    (1) Note for Guidance on the European Drug Master File Procedure – Draft, February 2002
    (EMEA/CVMP/134/02-CPMP/QWP/227/02-CONSULTATION)
    (http://www.emea.eu.int/pdfs/human/qwp/013402.pdf)
    (2) Council of Europe Public Health Committee, Resolution AP-CSP (99)4 Certification of suitability to the monographs of the European Pharmacopoeia (http://www.pheur.org/medias/download/APCSP9904E.pdf)
    (3) Regulatory Affairs Journal, May 2002, page 427

    Author:
    Dr Barbara Jentges
     

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