Draft EMEA Note for Guidance on DMF Procedures

GMP News No. 224

GMP News
23 August 2002

DraftEMEA Note for Guidance on DMF Procedures

Is the CEP becomingmandatory for existing active substances described in the EuropeanPharmacopoeia - CEP also for Herbal Medicinal Products?

The revised Note for Guidance on theEuropean Drug Master File Procedure (Draft, February 2002, 1) isintended to help applicants for human and veterinary medicinalproducts, when using the Drug Master File (DMF) procedure for activesubstances in the preparation of a dossier for an application to amarketing authorisation of a medicinal product – including lineextensions – or in the preparation of a dossier for an application for avariation of the Marketing Authorisation of a medicinal product.

According to this NfG there are 4 typesof active substances possible:

  • New active substances
  • Existing active substances describedin the European Pharmacopoeia
  • Existing active substances notdescribed in the European Pharmacopoeia, but described in thepharmacopoeia of a Member State
  • Existing active substances, notdescribed in the European Pharmacopoeia or the pharmacopoeia of aMember State

For type A, C and D the DMF procedure maybe used. The draft revision of the NfG proposes to make the CEP procedure(2) mandatory for those existing active substances described in theEuropean Pharmacopoeia (Type B). But – as mentioned in the introductorypart of the draft revision – the transition will require a change inlegislation. In this draft revision it is also stressed that in the eventthat a CEP is not yet available, the applicant should require his APIsupplier to seek a CEP at the EDQM.

With regard to the CEP-Procedure there isanother interesting news:
The newly established HMPWP (HerbalMedicinal Products Working Party) met for the first time on 11-12 March2002 at the EMEA in London, UK. The major objective of this working partyis to facilitate mutual recognition of marketing authorisations for herbalmedicinal products and minimise the need to invoke the CPMP arbitrationprocedure. One of the topics of this meeting was a report that waspresented by the European Pharmacopoeia where proposals for the extensionof the Certification procedure to herbal drugs and preparations werediscussed (3).


EDQM = European Directorate of Quality ofMedicines
HMPWP = Herbal Medicinal Products WorkingGroup
MA = Marketing Authorisation
MS = Member State
NfG = Note for Guidance

(1) Note for Guidance on the EuropeanDrug Master File Procedure – Draft, February 2002
(2) Council of Europe Public HealthCommittee, Resolution AP-CSP (99)4 Certification of suitability to themonographs of the European Pharmacopoeia (http://www.pheur.org/medias/download/APCSP9904E.pdf)
(3) Regulatory Affairs Journal, May 2002,page 427

Dr Barbara Jentges


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