Declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products

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Current effective version

Revision 1 - Adopted guideline

Reference numberEMEA/HMPC/CHMP/CVMP/287539/05 Rev. 1
Published28/04/2010
Effective from01/10/2010
KeywordsHerbal medicinal products, traditional herbal medicinal products, herbal substances, herbal preparations, extracts, declaration, summary of product characteristics (SmPC), package leaflet, labelling
DescriptionThis document outlines the principles for uniform declaration of herbal substances/preparations in herbal medicinal products as well as in traditional herbal medicinal products. It describes declaration in the summary of product characteristics (SmPC). Guidance on package leaflets, labelling and other herbal specific provisions for SmPC, package leaflets and labelling, have been added in Annex 1.


Document history

Revision 1

Current revision

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/10/2010–present


Published: 28/04/2010


Published: 29/01/2009


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