Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Scientific guideline
This guideline applies to human and veterinary medicines.
This document addresses specifications, i.e. those tests, procedures, and acceptance criteria used to assure the quality of the herbal substances/preparations and herbal medicinal products at release and during the shelf-life.
Keywords: Specifications, quality, herbal substances, herbal preparations, herbal medicinal products
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Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3 (PDF/437.33 KB)
Adopted
First published: 12/05/2022
EMA/HMPC/CHMP/CVMP/162241/2005 Rev. 3 -
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Draft guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3 (PDF/303.3 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/162241/2005
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Guideline on specifications: Test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Revision 1 (PDF/373.94 KB)
Adopted
First published: 30/03/2006
Last updated: 30/03/2006
Legal effective date: 23/03/2006
CPMP/QWP/2820/00 Rev 1 -
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Overview of comments received on draft guideline "guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal... (PDF/210.95 KB)
First published: 09/06/2006
Last updated: 09/06/2006
EMEA/CHMP/CVMP/QWP/40728/2006