Declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products - Scientific guideline
This guideline applies to human and veterinary medicines.
This 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.
Keywords: Herbal medicinal products, traditional herbal medicinal products, herbal substances, herbal preparations, extracts, declaration, summary of product characteristics (SmPC), package leaflet, labelling
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Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products in the SPC (PDF/155.63 KB)
Adopted
First published: 26/07/2007
Last updated: 28/04/2010
Legal effective date: 01/10/2010
EMEA/HMPC/CHMP/CVMP/287539/2005 -
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Overview of comments received on draft ‘Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products’ (EMEA/HMPC/CHMP/CVMP/287539/2005 Rev.1) (PDF/75.15 KB)
First published: 28/04/2010
Last updated: 28/04/2010
EMA/HMPC/710724/2009 -
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Draft guideline on declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products (PDF/152.26 KB)
Draft: consultation closed
First published: 29/01/2009
Last updated: 29/01/2009
EMEA/HMPC/CHMP/CVMP/287539/2005