New EMEA Guideline on Declaration of Herbal Medicinal Products

GMP News No. 797

GMP News
20 September 2006
 

New EMEA Guideline on Declaration of Herbal Medicinal Products

 
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)
 

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