Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products

This guideline applies to human and veterinary medicines.

Current effective version

PDF iconRevision 2 - Adopted guideline

Currently under revision - see below

Reference number EMA/HMPC/162241/2005 Rev. 2
Published 28/09/2011
Effective from 28/09/2011
Keywords Specifications, quality, herbal substances, herbal preparations, herbal medicinal products
Description 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 3
In progress

PDF iconDraft guideline


PDF iconConcept paper

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


Published: 01/06/2015

Revision 2

Current revision

PDF iconAdopted guideline

In operation: 28/09/2011–present
Revision 1

PDF iconAdopted guideline


PDF iconOverview of comments

In operation: 01/10/2006–28/09/2011


Published: 09/06/2006

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