Procedures for monograph and list entry establishment
Table of contents
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 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:
- 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 28/02/2019 to 31/08/2019
- Contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids
Calls open from 15/02/2019 to 15/05/2019
- Arctii radix
- Juniperi aetheroleum
- Juniperi pseudo-fructus
- Orthosiphonis folium
- Rosmarini aetheroleum
- Rosmarini folium
- Taraxaci folium
- Taraxaci radix cum herba
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 .
Standard operating procedure on establishment of Community herbal monographs, Community list entries and related documents (PDF/341.23 KB)Adopted
First published: 07/05/2009
Last updated: 03/10/2016
Legal effective date: 27/09/2016
Procedure for the preparation of Community monographs for herbal medicinal products with well-established medicinal use (PDF/80.73 KB)Adopted
First published: 12/01/2007
Last updated: 12/01/2007
EMEA/HMPC/182352/2005 Rev. 2
Procedure for the preparation of Community monographs for traditional herbal medicinal products (PDF/85.57 KB)Adopted
First published: 12/01/2007
Last updated: 12/01/2007
EMEA/HMPC/182320/2005 Rev. 2
Procedure for the appointment by the HMPC of a rapporteur responsible for a scientific evaluation or the establishment of a Community herbal monograph and / or Community list entry (PDF/50.27 KB)Adopted
First published: 13/03/2009
Last updated: 13/03/2009
Timelines for the establishment of a European Union herbal monograph and/or a European Union list entry (PDF/113.8 KB)Adopted
First published: 09/03/2007
Last updated: 07/11/2014
EMEA/HMPC/126542/2005 Rev.2 Corr.
- 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">European Union herbal monographs and list [...] st entries as Link}
- Template and recommended format for list of references
- Template for a European Union herbal monograph">European Union herbal monograph as Link}
- Template for overview of comments received on a draft European Union herbal monograph or 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">Committee on Herbal Medicinal Products public statements when E [...] stablished as Link}
- Template for a public statement when no European Union herbal monograph is established">European Union herbal monograph is established as Link}
Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2 (PDF/219.38 KB)Adopted
First published: 14/08/2018
Last updated: 14/08/2018
Legal effective date: 06/08/2018
Reflection paper on the reasons and timelines for revision of final Community herbal monographs and Community list entries (PDF/113.87 KB)Adopted
First published: 04/09/2008
Last updated: 09/03/2012
Annex 1 - Report template for the review of a European Union herbal monograph (DOCX/145.51 KB)
First published: 20/08/2018
Last updated: 20/08/2018
Public statement on the interpretation of therapeutic indications appropriate to traditional herbal medicinal products in Community herbal monographs (PDF/66.86 KB)Adopted
First published: 29/09/2011
Last updated: 29/09/2011
Matching patients-friendly therapeutic areas for browse search on herbal medicines for human use with ATC therapeutic groups (level 2) (PDF/79.7 KB)Adopted
First published: 28/06/2011
Last updated: 08/03/2016
EMA/568320/2009 Rev. 1
Glossary on herbal teas (PDF/87.69 KB)
First published: 28/04/2010
Last updated: 03/01/2011
EMA/HMPC/5829/2010 Rev. 1