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
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
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 30/04/2018 to 31/07/2018
- Andrographidis paniculatae folium
- Adhatodae vasicae folium
- Angelicae sinensis radix
- Bursae pastoris herba
- Centellae asiaticae herba
- Filipendulae ulmariae flos
- Filipendulae ulmariae herba
- Withaniae somniferae radix
Calls open from 31/03/2018 to 30/06/2018
- Quercus cortex
- Solidaginis virgaureae herba
- Tormentillae rhizoma
- Herniariae herba
- Verbenae citriodorae folium
- Menyanthidis trifoliatae folium
- Salviae mitiorrhizae radix et rhizoma
Calls open from 01/03/2018 to 31/05/2018
- Echinaceae angustifoliae radix
- Hamamelidis cortex
- Hamamelidis folium
- Hamamelidis folium et cortex aut ramunculus destillatum
- Mate folium
- Leonuri cardiacae herba
- Phaseoli fructus (sine semine)
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
Monograph update: systematic reviews and revisions
- Reflection paper on the reasons and timelines for revision of final European Union herbal monographs and list entries
- Procedure for the review and revision of European Union herbal monographs and/or European Union list entries
- Annex 1 - Report template for the review of a European Union herbal monograph
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