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

Current effective version

Final guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3

Adopted Reference Number: EMA/HMPC/CHMP/CVMP/201116/20051 Rev. 3

Document history - Revision 3

Draft guideline on quality of 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/201116/2005 Summary:

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.

Concept paper on the revision of the guideline on quality of herbal medicinal products/traditional herbal medicinal products

Draft: consultation closed Consultation dates: 01/06/2015 to 31/08/2015 Reference Number: EMA/HMPC/217631/2015 Summary:

Herbal medicinal products (HMPs) contain exclusively as active ingredients one or more herbal substances or herbal preparations or combinations thereof. For human and veterinary HMPs (authorised in accordance with Directives 2001/83/EC and 2001/82/EC, respectively) are applicable herbal-specific quality guidelines as well as general quality guidance for medicinal products. A new revision of the ‘Guideline on quality of HMPs/Traditional HMPs’ is proposed to take into account new and revised quality standards and guidance applicable for HMP/ Traditional HMPs.

Document history - Revision 2

Guideline on quality of herbal medicinal products traditional herbal medicinal products - Revision 2

Adopted Reference Number: EMA/HMPC/201116/2005 Rev. 2 Summary:

This guideline concerns the application of Module 3 of Annex I to Directive 2001/83/EC as amended for human herbal medicinal products and Part 2 of Annex I to Directive 2001/82/EC as amended for veterinary herbal medicinal products.

Document history - Revision 1

Guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 1

Adopted Reference Number: CPMP/QWP/2819/00 Rev 1 Legal effective date: 01/10/2006

Overview of comments received on draft guideline on quality of herbal medicinal products/traditional herbal medicinal products

Reference Number: EMEA/CHMP/CVMP/QWP/40683/2006