The establishment and publication of European Union (EU) herbal monographs and list entries is based on assessments by the European Medicines Agency’s (EMA) Committee on Herbal Medicinal Products (HMPC), which follow the procedures listed here.
At certain stages of the process, interested parties are invited to participate:
- to propose substances for assessment;
- to respond to calls for scientific data at the beginning of an assessment;
- to comment on draft monographs and list entries during public consultations.
Prioritised assessment by the HMPC
The HMPC identifies which herbal substances, preparations or combinations have priority to be covered by a monograph or a list entry.
Herbal substances proposed for assessment can be found in an inventory.
The herbal substances that have been selected for assessment and their current assessment status can be found in a priority list.
Proposing substances for assessment
Interested parties can submit proposals for the assessment of herbal substances or preparations relevant for harmonisation of the European market:
- Procedure on management of proposals from interested parties for European Union list entries or herbal monographs
- Guideline on the documentation to be submitted for inclusion into the 'community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products'
- Public statement on prioritisation for assessment of herbal substances associated with safety concern
Which substances are being assessed?
The HMPC assesses only substances for use in herbal medicinal products. Some herbal substances that are used in medicinal products can also be found in other product categories such as foods or cosmetics. The European Medicines Agency (EMA) does not work in the areas of food or cosmetics.
Submission of scientific data
The HMPC regularly invites the public to submit scientific data on herbal substances and preparations at the beginning of an assessment (first assessment or systematic review).
This information may then be used by the Committee in the development of EU monographs and/or EU list entries.
Public participation is an important way for members of the HMPC to obtain a complete set of bibliographic references and scientific data for a given assessment.
Scientific contributions in response to a call for the submission of scientific data can be provided to EMA for 3 months after publication.
Current and recent calls for scientific data
Call open from 28/02/2017 to 31/05/2017
Call open from 15/07/2016 to 15/10/2016:
Call open from 15/06/2016 to 15/09/2016:
Call open from 15/04/2016 to 15/07/2016:
Call open from15/12/2015 to 15/03/2016:
Call open from 14/10/2015 to 15/01/2016:
All draft EU herbal monographs and all draft EU list entries are available for public consultations as part of the Agency’s commitment to transparency and openness and in line with EU legislation.
EMA releases each draft monograph andr list entry with a draft list of references and in most cases the draft assessment report.
If the assessment shows that one or several requirements to establish a monograph or list entry are not fulfilled, EMA releases a draft public statement for three months’ public consultation.
To find draft monographs or draft list entries open for public consultation, please search the entries under:
Alternatively, go to ‘herbal medicines for human use’, select ‘browse by status’ and 'draft published', then click 'submit'.
To submit comments on draft EU monographs or draft European list entries, please use:
- Template for submission of comments on draft European Union herbal monograph or draft European Union list entry.
HMPC documents and templates
These documents and templates are used by the HMPC to ensure a streamlined and standardised assessment process:
- Standard operating procedure on establishment of European Union herbal monographs, European Union list entries and related documents
- Procedure for the preparation of European Union monographs for herbal medicinal products with well-established medicinal use
- Procedure for the preparation of European Union monographs for traditional herbal medicinal products
Rapporteurship and timelines
- Procedure for the appointment by the HMPC of a rapporteur responsible for a scientific evaluation or the establishment of a European Union herbal monograph and/or list entry
- Timelines for the establishment of a European Union herbal monograph and/or list entry
Templates for EU monographs and supporting documents
- Template for information exchange for the preparation of the assessment report supporting the establishment of European Union monographs and list entries
- Template for assessment report for the development of European Union herbal monographs and list entries
- Template and recommended format for list of references
- Template for a European Union herbal monograph
- Template for overview of comments received on on draft European Union herbal monograph or European Union list entry
EU list entries
- Structure of the list of herbal substances, preparations and combinations thereof
- Template for a European Union list entry
Cancellation of assessment works and public statements
- Procedure on the publication of Committee on Herbal Medicinal Products public statements when European Union herbal monographs on herbal substances, preparations and/or combinations thereof are not established
- Template for a public statement when no European Union herbal monograph is established
Systematic reviews and revisions
- Procedure for the systematic review of European Union herbal monographs and/or list entries and supporting documents
- Reflection paper on the reasons and timelines for revision of final European Union herbal monographs and list entries
Other important documents for monograph establishment
- Public statement on the interpretation of therapeutic indications appropriate to traditional herbal medicinal products in Community herbal monographs
- Matching patients friendly therapeutic areas for browse search on herbal medicines for human use with ATC therapeutic groups (level 2)
- Glossary on herbal teas
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Related EU legislation
- Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products
- Directive 2001/83/EC on the Community code relating to medicinal products for human use
- Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004
- Inventory of herbal substances for assessment (2017-01-03)
- HMPC: overview of assessment work – priority list (2016-12-15)
- Public statement on prioritisation for assessment of herbal substances associated with safety concerns (2015-10-23)
- HMPC monographs: Overview of recommendations for the uses of herbal medicinal products in the paediatric population (2016-02-18)