Human Medicines - II/Herbal Medicinal Products - Publication and consultation of entries to the Community list

Human Medicines II - Herbal Medicinal Products II
Publication and consultation of entries to the Community list
The ‘Community list of herbal substances1 , preparations2 and combinations thereof for use in traditional herbal medicinal products’ is established by the Committee on Herbal Medicinal Products (HMPC), in accordance with Directive 2001/83/EC as amended. The list is being gradually developed through entries of structured information relating to individual herbal substances or preparations.

Following the provisions of the Directive, the list shall contain, for each herbal substance or preparation, 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 medicinal product.

The Community list will provide a harmonised approach at EU level for providing the above-mentioned information on substance(s) or preparation(s) that constitute traditional herbal medicinal products. The list covers substances and preparations that have been in medicinal use for a sufficiently long time, and therefore considered not to be harmful under normal conditions of use.

When a draft entry for a given herbal substance or preparation has been produced by the Committee it is released for public consultation on this website, usually for a period of 3 months. The draft entry is then finalised by the Committee from a scientific point of view, before being submitted for approval by the European Commission. Following this approval, the final version of the Community list entry is published.

The HMPC is also responsible for establishing Community herbal monographs with particular relevance for the registration as well as the authorisation of herbal medicinal products. For a further description of this work, and for published Community monographs, please refer to: Community monographs

In contrast to the Community herbal monographs, the Community list 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 list;
- competent authorities will not have the opportunity to require additional data to assess the safety and the traditional use of the product.

An overview of ongoing HMPC assessment work in relation to establishing Community herbal monographs and/or enteries to the Community list can be found here.

1 The term ‘herbal substance’ is equivalent to the European Pharmacopoeia’s definition of a ‘herbal drug’, i.e. “… whole, fragmented or cut, plants, parts of plants, algae, fungi, lichen in an unprocessed state, usually in dried form but sometimes fresh.” (Ph. Eur. 2005).

2 The term ‘herbal preparation’ is equivalent to the European Pharmacopoeia’s definition of a ‘herbal drug preparation’, i.e. “… preparations obtained by subjecting [herbal substances] to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation.” (Ph. Eur. 2005).

Template for submitting comments on Draft Community Herbal Monograph / Draft Entry to the Community List

Entries to the Community List

abrir aquí:
Human Medicines - Herbal Medicinal Products - Publication and consultation of entries to the Community list