Assessment of clinical safety and efficacy in the preparation of Community herbal monographs for well-established and of Community herbal monographs/entries to the Community list for traditional herbal medicinal products/substances/preparations

  • Email
  • Help
Current effective version

Adopted guideline - Revision 1

Reference numberEMA/HMPC/104613/2005 Rev. 1
Published28/11/2017
Effective from28/11/2017
KeywordsHerbal medicinal products, clinical safety, efficacy, traditional use registration, marketing authorisation, European Union herbal monographs, European Union list of traditional herbal substances, preparations or combinations thereof
DescriptionThis guideline describes the legal background and recommendations for the assessment of data that are used to prepare European Union herbal monographs (formerly called Community herbal monographs) on herbal medicinal products and the European Union list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products. The areas of herbal medicinal products with well-established medicinal use and traditional herbal medicinal products are addressed.


Document history

Revision 1

Current version

Adopted guideline

 

Overview of comments

 

Draft guideline

 

 

Concept paper

In operation: 28/11/2017-present

 

Published: 28/11/2018

 

Published: 01/09/2016

Deadline for comments: 30/11/2016

 

Published: 16/10/2015

First version

 

Adopted guideline


Overview of comments

In operation: 01/03/2007-28/11/2017


Published: 07/09/2006


Related content


How helpful is this page?

Average rating:

 Based on 0 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
0 ratings
    

Tell us more