Quality of herbal medicinal products/traditional herbal medicinal products

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This guideline applies to human and veterinary medicines.

Current effective version

Revision 2 - Adopted guideline

Currently under revision - see below

Reference numberEMA/HMPC/201116/2005 Rev. 2
Effective from01/04/2012
KeywordsHerbal medicinal products, traditional herbal medicinal products, quality of herbal medicinal products
DescriptionThis 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.

Document history

Revision 3
In progress

Draft guideline


Concept paper

Pubished: 15/08/2018
Deadline for comments: 30/11/2018

Published: 01/06/2015

Revision 2

Current revision

Adopted guideline
In operation: 01/04/2012–present
Revision 1

Adopted guideline

Overview of comments

In operation: 01/10/2006–01/04/2012

Published: 09/06/2006

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