European Union herbal monographs

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A European Union 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 European Union.

A monograph contains the view of the HMPC on all information necessary for the use of a medicinal product containing the herbal substance or preparations described in the monograph:

  • 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 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.

Types of European Union monograph

European Union monographs are divided into two columns:

  • well-established use (marketing authorisation): demonstrated with sufficient safety and efficacy data;
  • traditional use (simplified registration): 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.

Public consultation

When the HMPC produces a draft European Union 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 this website.

Use of a final European Union herbal monograph

A final European Union 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. Even though the 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 to bring harmonisation to this field and to facilitate the use of the simplified registration procedure.

For more information on the use of European Union monographs in procedures for placing a herbal medicinal product on the market in a particular Member State, refer to the national competent authority.

Searching for European Union herbal monograph documents

  • To view all European Union herbal monographs, go to the document library and search using the document type, 'Herbal - European Union herbal monograph'.
  • To browse for existing European Union herbal monographs and supporting documents by herbal substance, use, status or outcome go to "Find medicine", herbal medicines for human use.

Table of contents

General procedural guidance

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Assessment - proposals, prioritisation and status

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Rapporteurship and timelines

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European Union herbal monographs

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Document(s) Language Status First published Last updated Effective Date
Procedure for the preparation of Community monographs for herbal medicinal products with well-established medicinal use (English only) adopted 11/01/2007    
Procedure for the preparation of Community monographs for traditional herbal medicinal products (English only) adopted 11/01/2007    
Template for a European Union herbal monograph (English only) adopted 16/07/2009 17/11/2014  
Template for a European Union herbal monograph (English only) adopted 16/07/2009 17/11/2014  

Cancellation of assessment works and public statements

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Supporting documents: market overview, assessment report, list of references, overview of comments

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Systematic reviews and revisions

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Other (miscellaneous)

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Document(s) Language Status First published Last updated Effective Date
Matching patients-friendly therapeutic areas for browse search on herbal medicines for human use with ATC therapeutic groups (level 2) (English only) adopted 28/06/2011 08/03/2016  

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