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Homeopathic Medicinal Products Working Group (HMPWG)

 

Public consultation on the third draft list of entries of stocks for which homeopathic use is justified

Stakeholders are invited to submit their comments to homeo@fagg-afmps.be by 15 December 2014

Third draft list of justified stocks

Public consultation on Question & Answer document: Issue 6 - LHRD

Stakeholders are invited to submit their comments to the chairperson of the FSD subworking group: Werner Knoess werner.knoess@bfarm.de by 31 October 2014

Question and Answer document: Issue 6


Public consultation on Assessment and list entries of Atropa belladonna 2a and Rh, Atropinum sulfuricum and Chimaphilia (2nd drafts revised after the first public consultation - second consultation)

Stakeholders are invited to submit their comments to the chairperson Werner Knoess, werner.knoess@bfarm.de by 31 October 2014

FSD Atropa belladonna 2a Assessment Report

FSD Atropa belladonna 2a List Entry

FSD Atropa belladonna Rh Assessment Report

FSD Atropa belladonna Rh List Entry

FSD Atropinum sulfuricum Assessment Report

FSD Atropinum sulfuricum List Entry

FSD Chimaphila umbellata Assessment Report (second consultation)

FSD Chimaphila umbellata List Entry (second consultation)

  • 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

  • Compilation of comments received from public consultation (2012) on FSD assessments
    Published August 2014
    Click here
  • 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

  • 5-6 June 2014, Paris (France): report
  • 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