European Medicines Agency
Inspections
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EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
London, 27 April 2005
EMEA/CVMP/134/02 Rev 2 Consultation
CPMP/QWP/227/02 Rev 2 Consultation
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
GUIDELINE ON ACTIVE SUBSTANCE MASTER FILE PROCEDURE
DISCUSSION AT THE HMPC
November 2005 – January 2006
ADOPTION BY THE HMPC
22 January 2006
DRAFT AGREED BY QUALITY WORKING PARTY
February 2006
ADOPTION BY CHMP FOR RELEASE FOR
CONSULTATION
23 March 2006
ADOPTION BY CVMP FOR RELEASE FOR
CONSULTATION
20 April 2006
END OF CONSULTATION (DEADLINE FOR
COMMENTS)
30 August 2006
Note:
From 1st November 2005, Directive 2004/24/EC1 relating to traditional herbal medicinal products
came into force in all Member States in the European Union allowing the establishment of a simplified
procedure for the registration of traditional herbal medicinal products for human use.
In order to facilitate the use of the ASMF procedure in the area of herbal medicinal products, the
Committee for Herbal Medicinal Products proposes an Annex on herbal substances/preparations (see
Annex 1, table 3) to the Guideline on the Active Substance Master File procedure.
It should be noted that the principles which are outlined in this guideline in relation to traditional
herbal medicinal products are equally applicable to other herbal medicinal products, both for Human
and Veterinary use, which do not follow the simplified registration procedure. The new table (Annex
1, table 3) takes into account the particularities of herbal substances/preparations whilst also
highlighting that this procedure is/can be applied to active substances/preparations of herbal or