European Union monographs and list entries
The Committee on Herbal Medicinal Products (HMPC) compiles and assesses scientific data on herbal substances, preparations and combinations with a focus on safety and efficacy. This work supports the harmonisation of the European market: national competent authorities are able to refer to one unique set of information on a herbal substance or preparation when evaluating marketing applications.
European Union monographs
A European Union (EU) herbal monograph (formerly known as Community herbal monograph) contains the HMPC's scientific opinion on safety and efficacy data about a herbal substance and its preparations intended for medicinal use. The HMPC evaluates all available information, including non-clinical and clinical data, but also documented long-standing use and experience in the EU.
EU monographs provide all information necessary for the use of a medicinal product containing a specific herbal substance or preparation:
- what the herbal product is used for;
- who the herbal product is intended for;
- safety information such as information regarding undesirable effects and interactions with other medicines.
Monographs form the basis for the required individual medicinal product information such as the summary of product characteristics (SmPC) and the package leaflet. They are published together with other documents, including an assessment report containing reviews of all available data relevant for the medicinal use of the herbal substance or preparations.
EU monographs are divided into two sections:
|Well-established use (marketing authorisation)||Traditional use (simplified registration)|
|Demonstrated with sufficient safety and efficacy data||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. This is why some preparations will appear in the well-established use section of the monograph and others will be in the traditional use section. If data are insufficient, some preparations might not be included.
Using EU herbal monographs for applications
A final EU 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 are taken into account by Member States when examining an application. While Member States are not obliged to follow the monographs, any decision not to accept the content of a monograph as adopted by the HMPC should be duly justified taking into account their important role in bringing harmonisation to this field and to facilitate the use of the simplified registration procedure.
When EMA publishes an HMPC opinion, this includes the monograph, the supporting assessment report and divergent positions of individual HMPC members if the monograph was not adopted by consensus (see article 7 of the HMPC Rules of procedure ).
For more information on the use of EU monographs in procedures for placing a herbal medicinal product on the market in a particular Member State, refer to the relevant national competent authority.
Finding EU herbal monographs
- To view all EU herbal monographs, or to browse for existing EU herbal monographs and supporting documents by herbal substance, go to Herbal: European Union herbal monographs.
European Union list entries
To complement traditional-use monographs on herbal substances, the HMPC gradually develops the European Union list (formerly known as Community list) through 'list entries'.
Unlike EU herbal monographs, EU list entries are legally binding on applicants and national competent authorities in the Member States.
Draft list entries are developed by the HMPC, but the final list entries are adopted and published by the European Commission.
Using EU list entries for applications
If applicants for traditional use registration can demonstrate that their proposed product and related claims in the application comply with the information contained in the EU list, they will not need to provide evidence of its safe and traditional use.
National competent authorities cannot require additional data to assess the safety and the traditional use of the product.
List entries are the basis of a medicinal product's summary of product characteristics (SmPC).
Finding EU list entries
- To view all EU draft list entries, go to Herbal: European Union list entry
- To view all final EU list entries adopted by the European Commission, refer to the European Commission's webpage on herbal medicinal products.