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

Current effective version

Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3

Adopted Reference Number: EMA/HMPC/CHMP/CVMP/162241/2005 Rev. 3

Document history - Revision 3

Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3

Adopted Reference Number: EMA/HMPC/CHMP/CVMP/162241/2005 Rev. 3

Draft guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3

Draft: consultation closed Consultation dates: 15/08/2018 to 30/11/2018 Reference Number: EMA/HMPC/162241/2005 Summary:

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.

Document history - Revision 2

Guideline on specifications test procedures and acceptance criteria for herbal substances herbal preparations and herbal medicinal products traditional herbal medicinal products - Revision 2

Adopted Reference Number: EMA/HMPC/162241/2005 Rev. 2 Summary:

This guidance document provides general principles on the setting and justification, to the extent possible, of a uniform set of specifications for herbal substances/preparations and herbal medicinal products to support applications for marketing authorisation or registration according to Directives 2001/82/EC and 2001/83/EC as amended.

Document history - Revision 1

Guideline on specifications: Test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Revision 1

Adopted Reference Number: CPMP/QWP/2820/00 Rev 1 Legal effective date: 23/03/2006

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...

Reference Number: EMEA/CHMP/CVMP/QWP/40728/2006