Community list entries

In contrast to the Community herbal monographs, the ‘Community list of herbal substances , preparations and combinations thereof for use in traditional herbal medicinal products’ is legally binding to applicants and competent authorities in the Member States in so far as:

• an applicant will not be required to provide evidence of the safe and traditional use of a medicinal product for which he seeks a traditional use registration if he demonstrates that the proposed product and related claims in the application comply with the information contained in the Community list;
• competent authorities will not have the opportunity to require additional data to assess the safety and the traditional use of the product.

The Community list is developed gradually through ‘list entries’. When a draft list entry for a given herbal substance or preparation has been produced by the Committee, it is released for public consultation on this website for a period of three months. The list entry is then finalised by the Committee on Herbal Medicinal Products (HMPC) from a scientific point of view, before being submitted for approval by the European Commission. Following this approval, the Commission Decision amending the Community list is published by the European Commission.

A list entry document contains:

• The scientific and botanical name, and the common name in all EU languages;
• What is it used for (the indication);
• The specified strength and the posology;
• The route of administration and;
• any other information necessary for the safe use of the herbal substance or preparation used as an ingredient of a traditional herbal medicinal product, including warnings, precautions and contraindications.

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