11/26/22, 6:47 PM Committee on Herbal Medicinal Products (HMPC) | European Medicines Agency

Committee on Herbal Medicinal Products (HMPC)

The Committee on Herbal Medicinal Products (HMPC) is the European Medicines Agency's (EMA)
committee responsible for compiling and assessing scientific data on herbal substances, preparations
and combinations, to support the harmonisation of the European market.

The HMPC replaced the Committee for Proprietary Medicinal Products' Working Party on Herbal Medicinal
Products in September 2004.

The Committee was established in accordance with Regulation (EC) No 726/2004  and the Herbal
Directive , which introduced a simplified registration procedure for traditional herbal medicinal products
in EU Member States.

The HMPC is composed of scientific experts in the field of herbal medicines.

Role of the HMPC

The HMPC prepares the Agency's opinions on herbal substances and preparations, along with information on
recommended uses and safe conditions.

This work supports the harmonisation of the European market: national competent authorities are able to
refer to one unique set of information on a herbal substance or preparation when evaluating marketing
applications for herbal medicines.

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11/26/22, 6:47 PM Committee on Herbal Medicinal Products (HMPC) | European Medicines Agency

To support EU Member States, the HMPC focuses on two main tasks:

establishing EU monographs covering the therapeutic uses and safe conditions of well-established
and/or traditional use for herbal substances and preparations;
drafting an EU list of herbal substances, preparations and combinations thereof for use in traditional
herbal medicinal products.

The HMPC and its working parties and other groups also:

prepare scientific guidelines and regulatory guidance to help companies prepare marketing
authorisation and registration applications for herbal medicines;

prepare opinions on questions referred to EMA by the national competent authorities regarding the
period and evidence of safe use for traditional herbal medicinal products;

cooperate with the European Directorate for the Quality of Medicines and Healthcare  on European
Pharmacopoeia standards and EMA guidance on the quality of herbal medicines;
coordinate with other scientific committees at the Agency on the regulation and safe use of herbal
medicines;
provide scientific and regulatory support to companies researching and developing herbal medicines;
interact with interested parties;
provide advice and training to herbal assessors of national competent authorities;
cooperate with international partners on the harmonisation of regulatory requirements.

For full details, see:

HMPC rules of procedure (PDF/182.38 KB)

First published:
05/11/2009

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