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Homeopathic Medicinal Products Working Group (HMPWG)

 

Public Consultation - Questions & Answers on First Safe Dilutions

The comments on the document "Questions and Answers on First Safe Dilutions" should be sent to the chair of the FSD subgroup Werner.Knoess@bfarm.de and to the chair of the HMPWG laurence.girod@ansm.sante.fr by 24/06/2014.


The Homeopathic Medicinal Products Working Group (HMPWG) agreed to elaborate First Safe Dilutions (FSDs) for homeopathic stocks/preperations in accordance with the provisions of Directive 2001/83/EC. Discussions amongst the Member States during meetings of the HMPWG and also general comments by interested parties, which were raised on a set of FSDs and corresponding assessment reports published for consultation, demonstrated the need for some clarifications. The following questions & answers are taking into account the discussions and comments. They address some basic principles related to the assessment of homeopathic stocks/preperations, development of FSDs and the interpretation/usage of the document "Points to consider on non-clinical safety of homeopathic medicinal products of botanical, mineral and chemical origin". The questions & answers also outline important issues for using FSDs in applications.

The list of questions & answers is reflecting the harmonized view of the HMPWG. The list is not exhaustive and will be amended or revised if necessary.

 

EU Heads of Medicines Agency (HMA) agreed in 2004 to establish a Homeopathic Medicinal Products Working Group (HMPWG) to coordinate the implementation of the Directive 2001/83/EC amended by Directive 2004/27/EC.

HMPWG acts as a forum for exchange of regulatory and scientific expertise regarding the assessment of homeopathic medicinal products in Europe. HMPWG provides guidance on the assessment of homeopathic medicinal products and on the registration of homeopathic medicinal products.

Composition of HMPWG

The HMPWG is composed of representatives from the National Competent Authorities (NCAs). Representatives of the European Commission (EC) and European Medicines Agency (EMA) are invited to attend all meetings of the HMPWG. Observers from European Directorate for the Quality of Medicines and Healthcare (EDQM), the EFTA countries and the World Health Organisation (WHO) may also participate.

HMPWG is currently chaired by Laurence Girod (ANSM)

Contact: laurence.girod@ansm.sante.fr

(+33) 1 55 87 33 76

  • Mandate of the HMPWG 
    Adopted November, 2004
    click here
  • Rules of Procedure for HMPWG
    Adopted HMA Dublin, January 2013
    Click here
  • Rules of Procedure for the HMPWG
    Adopted July 2007
    click here

Templates for Public Consultations

  • Template for submission of comments on draft document  (Word format)
    Adopted November 2013
    Click here
  • Template for overview of comments received on draft document (Word format)
    Adopted November 2013
    Click here

First Safety Dilutions (FSD) Sub-group

  • FSD Sub-working group Mandate
    Adopted May 2013
    Click here

  • FSD Sub-working group General Work Programme
    Adopted May 2013
    Click here

Homeopathic Use

  • Mandate of the Homeopathic Use sub-group
    Adopted November 2013
    Click here
  • General Work Programme for the sub-group on Homeopathic Use
    Click here
  • First list of justified stocks
    Click here
  • Preamble to the first list of justified stocks
    Click here
  • Answer of the HMPWG to the stakeholders after the public consultation on the first list
    Click here

Guidance documents - Notice To Applicants

  • Renewal Application Form
    Published September 2011
    click here
  • Notice to Applicants Volume 2B Module 1 - Homeopathic application form (Word format)
    March 2014
    click here

Guidance documents on Quality

  • Guidance on module 3
    November 2007
    click here
  • Points to consider on Stability Testing of HMPs
    Approved by HMA July 2009
    click here

Guidance documents on Safety

  • Introduction of the List of First Safe Dilutions
    Adopted by HMA, May 2010
    Click here
  • Structure of the List of First Safe Dilutions
    Adopted by HMA, May 2010
    Click here
  • First Safe Dilutions AR Template
    Adopted May 2010
    click here
  • Points to consider on non-clinical safety of homeopathic medicinal products of botanical, mineral and chemical origin
    July 2007
    click here
  • Points to Consider on Safety of Homeopathic Medicinal Products from Biological Origin
    July 2007
    click here

Guidance documents on homeopathic use

  • Points to consider on the justification of homeopathic use of stock (June 2012)
    Click here

Reports from meetings

  • 21-22 November 2013, Bonn (Germany): report
  • 30-31 May 2013, Dublin (Ireland): report
  • 23 October 2012, Gdansk (Poland): report
  • 5-6 June 2012, Copenhagen (Denmark): report
  • 7-8 June 2011, Budapest (Hungary): report