Procedures for monograph and list entry establishment

  • Email
  • Help

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 inventory

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

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.

                                                                   back to top

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

Call open from 28/02/2017 to 31/05/2017

Call open from 15/07/2016 to 15/10/2016:

Call open from 15/06/2016 to 15/09/2016:

Call open from 15/04/2016 to 15/07/2016:

Call open from15/12/2015 to 15/03/2016:

Call open from 14/10/2015 to 15/01/2016:

back to top

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 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:

back to top

HMPC documents and templates 

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

Procedural guidance

Rapporteurship and timelines

Templates for EU monographs and supporting documents

EU list entries

Cancellation of assessment works and public statements

Systematic reviews and revisions

Other important documents for monograph establishment

How helpful is this page?

Average rating:

 Based on 3 ratings

Add your rating:

See all ratings
1 ratings
0 ratings
0 ratings
0 ratings
2 ratings
    

Tell us more

Related content

Related EU legislation

Related documents