Procedures for monograph and list entry establishment
HerbalRegulatory and procedural guidance
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 the document below:
The herbal substances that have been selected for assessment and their current assessment status can be found below:
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 15/02/2024 to 15/05/2024
- Agni casti fructus
- Cimicifugae rhizoma
- Echinaceae angustifoliae radix
- Echinaceae pallidae radix
- Echinaceae purpureae herba
- Echinaceae purpureae radix
- Oleae folium
- Plantaginis ovatae semen
- Plantaginis ovatae seminis tegumentum
- Polypodii rhizoma
- Ribis nigri folium
Calls open from 01/03/2024 to 31/05/2024
- Avenae fructus
- Avenae herba
- Boldi folium
- Calendulae flos
- Gentianae radix
- Lini Semen
- Lupuli flos
- Rusci rhizoma
- Sambuci flos
- Thymi herba and Primulae radix
Calls open from 01/04/2024 to 30/06/2024
- Curcumae longae rhizoma
- Cynarae folium
- Meliloti herba
- Melissae folium
- Myrrha
- Oenotherae oleum
- Uvae ursi folium
- Verbasci flos
- Vitis viniferae folium
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:
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:
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