Clinical assessment of fixed combinations of herbal substances/herbal preparations

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Current effective version

Adopted guideline

Reference numberEMEA/HMPC/166326/05
Effective from01/07/2006
KeywordsHerbal fixed-combination products
DescriptionThis document explains how to structure the clinical documentation of herbal fixed-combination products. It also provides advice to assessors for an assessment of the clinical safety and efficacy. 

Document history

First version

Current version

Adopted guideline


Overview of comments

In operation: 01/07/2006–present


Published: 09/04/2014

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