Human Medicines - Herbal Medicinal Products - Adopted Monographs

Human Medicines - Herbal Medicinal Products
Publication and consultation of Community monographs
In accordance with Directive 2001/83/EC as amended, the Committee on Herbal Medicinal Products (HMPC) is responsible for establishing Community herbal monographs. These will have relevance for the registration as well as the authorisation of herbal medicinal products.

A Community herbal monograph comprises the Committee’s scientific opinion on a given herbal medicinal product, based on its evaluation of available scientific data (well-established use) or on the historic use of that product in the European Community (traditional use). For some herbal medicinal products, the Community monograph covers both well-established use and traditional use.

The Community herbal monographs provide a harmonised approach to the scientific assessment of herbal medicinal products in the EU, and the Member States shall take them into account when they examine an application relating to a product for which a Community monograph has been established.

When the HMPC has produced a draft Community monograph it is released for public consultation on this website, usually for a period of 3 months. The comments received are subsequently reviewed and the final version of the Community herbal monograph is published.

The HMPC is also responsible for establishing a ‘Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products’. For a further description of this work, and for published draft entries to the list, please refer to: Community list

In contrast to the Community list, Community herbal monographs are not legally binding. A Community herbal monograph covering the traditional use of a substance, preparation or combination shall be taken into account by competent authorities when examining a traditional use registration application, which is based on the information contained in this monograph. A national competent authority may have a different position on a certain recommendation or statement set out in the monograph. The applicant may therefore be requested by a competent authority to provide supplementary information during the national evaluation procedure, in particular on the safety and the traditional use of the product.

Human Medicines - Herbal Medicinal Products - Adopted Monographs