Community herbal monographs

A Community herbal monograph comprises the scientific opinion of the Committee on Herbal Medicinal Products (HMPC) on safety and efficacy data concerning a herbal substance and its preparations intended for medicinal use. The HMPC evaluates scientifically all available information including non-clinical and clinical data but also documented long-standing use and experience in the Community.

Community monographs are divided into two columns: well-established use (marketing authorisation) and traditional use (simplified registration).

• well-established use: demonstrated with sufficient safety and efficacy data,
• traditional use: accepted on the basis of sufficient safety data and plausible efficacy.

Each herbal preparation is assessed individually as information available may vary from one preparation to another. As a result some preparations will appear in the well-established use section of the monograph and others will be in the traditional use section. Some preparations might not be included if data are insufficient.

A monograph contains the view of the HMPC on all information necessary for the use of a medicinal product containing the herbal substance/preparation(s) described in the monograph:

• What the herbal product is used for,
• For whom the herbal product is intended (e.g. adults only or children as well, in pregnant and lactating women, etc.),
• Safety information such as information regarding undesirable effects and interaction with other medicines.

The monographs are published with other documents including an assessment report containing reviews of all available data relevant for the medicinal use of the herbal substance/preparations.

When the HMPC produces a draft Community monograph, it is released for public consultation on this website for a period of  three months. Comments received are subsequently evaluated and discussed and the final version of the monograph is published on the Agency website.

Use of a final Community herbal monograph

A final community monograph can be used in application reference material by a marketing authorisation applicant (well-established use part) and by a traditional use registration applicant (traditional use part).

Final monographs shall be taken into account by the member states when examining an application. Even though the member states are not obliged to follow the monographs, any decision not to accept the content of the monograph as it is adopted by the HMPC should be duly justified taking into account their important role to bring harmonisation to this field and to facilitate the use of the simplified registration procedure.

For more information on the use of community monographs in procedures for placing a herbal medicinal product on the market in your member state, please refer to your national competent authority.

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