Union Herbal Monographs

The European Medicines Agency (EMA) has a Committee on Herbal Medicinal Products (HMPC), see Article 16h of Directive 2001/83/EC. Its aim is i.a. to facilitate the harmonization of the processes of approval and registration for (traditional) herbal medicinal products in the EU.

Union Monographs

The Committee has as one of its functions to establish Union monographs for herbal substances and preparations. In each monograph, the HMPC evaluate and specify information about the preparation, use and safety, which can be used to define individual herbal medicinal products. The information is divided into two columns, one for approval based on well established medicinal use and one for registration based on traditional use. The assessment is made on different herbal preparations, which is why information may differ between the two columns for the same plant material. Monographs of herbal substances, along with the assessment reports, can be found at the EMA website using the link in the right pane menu.

Commission list entries

The EU Commission adopts, following proposals from the HMPC, a list of herbal substances and preparations which may be part of traditional herbal medicinal products. The list contains, for each substance / preparation, the indication, strength, dosage, route of administration and the scientific name of the relevant plant.

 
 
 

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