Clinical assessment of fixed combinations of herbal substances/herbal preparations - Scientific guideline

This 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.

Keywords: Herbal fixed-combination products

Current effective version

Guideline on the clinical assessment of fixed combinations of herbal substances / herbal preparations

Adopted Reference Number: EMEA/HMPC/166326/2005 Legal effective date: 01/07/2006

Document history - First version (current)

Guideline on the clinical assessment of fixed combinations of herbal substances / herbal preparations

Adopted Reference Number: EMEA/HMPC/166326/2005 Legal effective date: 01/07/2006

Overview of comments received on guideline on the clinical assessment of fixed combinations of herbal substances / herbal preparations

Reference Number: EMEA/HMPC/419395/2005