Quality of herbal medicinal products/traditional herbal medicinal products - Scientific guideline
This guideline applies to human and veterinary medicines.
This document intends to cover the general quality aspects of herbal medicinal products for human and veterinary use, including traditional herbal medicinal products for human use. It describes the special problems of herbal medicinal products and the differences between medicinal products containing chemically defined active substances. Read together with questions and answers.
Keywords: Herbal medicinal products, traditional herbal medicinal products, quality of herbal medicinal products
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Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 (PDF/205.93 KB)
Draft: consultation closed
First published: 15/08/2018
Last updated: 15/08/2018
Consultation dates: 15/08/2018 to 30/11/2018
EMA/HMPC/201116/2005 -
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Concept paper on the revision of the guideline on quality of herbal medicinal products/traditional herbal medicinal products (PDF/76.93 KB)
Draft: consultation closed
First published: 01/06/2015
Last updated: 01/06/2015
Consultation dates: 01/06/2015 to 31/08/2015
EMA/HMPC/217631/2015
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Guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 1 (PDF/197.94 KB)
Adopted
First published: 30/03/2006
Last updated: 30/03/2006
Legal effective date: 01/10/2006
CPMP/QWP/2819/00 Rev 1 -
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Overview of comments received on draft guideline on quality of herbal medicinal products/traditional herbal medicinal products (PDF/242.48 KB)
First published: 09/06/2006
Last updated: 09/06/2006
EMEA/CHMP/CVMP/QWP/40683/2006