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 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

• HMPC: overview of assessment work - 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

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

Current and recent calls for scientific data

Calls open from 31/03/2023 to 30/06/2023

• Fragariae folium
• Lecithinum ex soya
• Malvae sylvestris flos
• Matricariae aetheroleum
• Soiae oleum raffinatum
• Malvae folium

Calls open from 30/04/2023 to 31/07/2023

• Allii sativi bulbus
• Mastic
• Silybi mariani fructus
• Combination: Species diureticae

Calls open from 15/06/2023 to 15/09/2023

• Maydis stigma

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.

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 .

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

• 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 a draft European Union herbal monograph or European Union list entry

• Structure of the list of herbal substances, preparations and combinations thereof
• Template for a European Union list entry

• 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