Procedures for monograph and list entry establishment

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 on this page.

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 the document below:

Inventory of herbal substances for assessment

Adopted Reference Number: EMA/HMPC/494079/2007

The herbal substances that have been selected for assessment and their current assessment status can be found below:

HMPC: overview of assessment work - priority list

Adopted Reference Number: EMA/HMPC/561868/2021

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'

Adopted Reference Number: EMEA/HMPC/107399/2005 Rev. 1

Public statement on prioritisation for assessment of herbal substances associated with safety concerns

Adopted Reference Number: EMA/HMPC/682247/2013 Rev. 1 Summary:

Based on the above-mentioned concerns and considerations the HMPC is of the opinion not to consider as a priority detailed assessments of the annexed list of herbal substances because it is foreseen that a Community herbal monograph cannot be established due to a likely unfavourable benefit-risk assessment.

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.

Procedure for calls for scientific data for use in HMPC assessment work

Adopted Reference Number: EMEA/HMPC/1004/2006 Rev.6

Current and recent calls for scientific data

Calls open from 01/04/2025 to 30/06/2025

• Althaeae radix
• Carvi aetheroleum
• Carvi fructus
• Equiseti herba
• Hamamelidis cortex
• Hamamelidis folium
• Hamamelidis folium et cortex aut ramunculus destillatum
• Harpagophyti radix
• Psyllii semen
• Salicis cortex
• Valerianae radix and Lupuli flos

Call open from 15/04/2025 to 15/07/2025 – new assessment

• Valerianae radix and Passiflorae herba

Public consultations

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 and 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:

• Public consultations.

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

Reference Number: EMA/HMPC/384286/2006

HMPC documents and templates

These documents and templates are used by the HMPC to ensure a streamlined and standardised assessment process:

Procedural guidance

Procedure for the preparation of European Union herbal monographs and European Union list entries and appointment of HMPC rapporteurs and peer-reviewers

Adopted Reference Number: EMA/HMPC/887331/2022

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 European Union 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

Monograph update: systematic reviews and revisions

Reflection paper on the reasons and timelines for revision of final Community herbal monographs and Community list entries

Adopted Reference Number: EMEA/HMPC/326440/2007

Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 3

Adopted Reference Number: EMA/HMPC/124695/2011 Rev.3

Annex 1 - Report template for the review of a European Union herbal monograph

Other important documents for monograph establishment

Draft reflection paper on data recommendations for herbal medicinal products and traditional herbal medicinal products used in children and adolescents

Draft: consultation closed Consultation dates: 01/06/2025 to 31/08/2025 Reference Number: EMA/HMPC/71333/2023 Summary:

Comments should be provided using this template to [e-mail] 

Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues

Draft: consultation closed Consultation dates: 01/02/2025 to 01/05/2025 Reference Number: EMA/HMPC/224438/2024 Summary:

Comments should be provided using this template to [e-mail]

Public statement on the interpretation of therapeutic indications appropriate to traditional herbal medicinal products in Community herbal monographs

Adopted Reference Number: EMA/HMPC/473587/2011

Matching patients-friendly therapeutic areas for browse search on herbal medicines for human use with ATC therapeutic groups (level 2)

Adopted Reference Number: EMA/568320/2009 Rev. 1 Summary:

Understanding the EMA website search tool ‘browse by use’

Glossary on herbal teas

Reference Number: EMA/HMPC/5829/2010 Rev. 1