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

AdoptedLegal effective date: Reference Number: EMEA/HMPC/166326/2005

English (EN) (155.17 KB - PDF)

First published: Last updated:
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Document history - First version (current)

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

AdoptedLegal effective date: Reference Number: EMEA/HMPC/166326/2005

English (EN) (155.17 KB - PDF)

First published: Last updated:
View

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

Reference Number: EMEA/HMPC/419395/2005

English (EN) (178.45 KB - PDF)

First published: Last updated:
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