Non-clinical documentation for herbal medicinal products in applications for marketing authorization

  • Email
  • Help
Current effective version

Adopted guideline

Currently under revision - see below

Reference numberEMEA/HMPC/32116/05
Published07/09/2006
Effective from13/07/2006
KeywordsHerbal medicinal products, non-clinical, traditional use registration, Community herbal monographs, Community list of herbal substances, toxicity, genotoxicity, carcinogenicity, reproduction
DescriptionThis document provides guidance on the minimum requirements for non-clinical data for wellestablished herbal medicinal products. It applies to bibliographical and mixed applications for marketing authorisations and to applications for simplified registration.


Document history

Revision 1

In progress

Draft guideline

 

 

Concept paper

Published: 22/08/2017

Deadline for comments: 30/11/2017

 

 

Published: 02/09/2016

First version

Current version

Adopted guideline

 

 

Overview of comments

In operation: 13/07/2006–present

 

 

Published: 01/11/2007


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