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:

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 PDF icon inventory .

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

Proposing substances for assessment

Interested parties can submit proposals for the assessment of herbal substances or preparations relevant for harmonisation of the European market:

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

Calls open from 15/02/2023 to 14/05/2023

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

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


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:

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:

HMPC documents and templates

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



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