On 22 June 2006 the EMEA issued the draft of the Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC" (EMEA/HMPC/CHMP/CVMP/287539/2005).

With the regulations the authority intends to establish common criteria for the declaration of herbal substances/preparations in the SPCs (Summary Product Characteristics) of herbal medicinal products and traditional herbal products. The draft also introduces a number of examples for various extracts and dosage forms.

The complete document can be found here:
http://www.emea.eu.int/pdfs/human/hmpc/28753905en.pdf

Comments can still be forwarded to the Committee on Herbal Medicinal Products (HMPC) Office – deadline is the 31 December 2006.

Author
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)