Homeopathic Medicinal Products Working Group (HMPWG)

Introduction/Overview

European group dedicated to homeopathic medicinal products for human and veterinary use

Mandate

  • To create a forum for exchange of regulatory and scientific expertise regarding the assessment of the quality, safety and homeopathic use of homeopathic medicinal products for human and veterinary use;
  • To provide guidance on the assessment of homeopathic medicinal products on request from Competent Authorities;
  • To provide guidance for applicants on the registration of homeopathic medicinal products;
  • To establish one common dossier template for applications for the registration (Article 14 of Directive 2001/83/EC, as amended) of homeopathic medicinal products in the EU, in co-operation with the Notice to Applicants Group;
  • To provide advice and expertise on request of the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMD(h)) and Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) on procedural, regulatory and scientific issues arising from the mutual recognition and decentralised procedures applicable to homeopathic medicinal products;
  • To facilitate the resolution of procedural, regulatory, and scientific issues arising from variation procedures pertaining to homeopathic medicinal products;
  • To support the drafting of a list of safe dilution grades for homeopathic medicinal products;
  • To address regulatory and scientific issues concerning homeopathic medicinal products on request by the European Commission, the CMD(h), the CMD(v), the Heads of Medicines Agencies and the EDQM;
  • To draft rules of procedure for approval by the Heads of Medicines Agencies;
  • To prepare guidance documents which will be presented to the Heads of Medicines Agencies for publication on their website.

Members and Representatives

  • The HMPWG is composed of representatives from the National Competent Authorities (NCAs) and  a veterinarian representative . 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.
  • meeting cycle : 2 meetings / year,  once per EU-presidency
  • (Acting) Chair: Bianca Maria Bruno

Contact

Contact Point: Bianca Maria Bruno

bm.bruno@aifa.gov.it

Key documents list

Public consultation on the third 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 | pdf


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 | pdf

FSD Atropa belladonna 2a List Entry | pdf

FSD Atropa belladonna Rh Assessment Report | pdf

FSD Atropa belladonna Rh List Entry| pdf

FSD Atropinum sulfuricum Assessment Report | pdf

FSD Atropinum sulfuricum List Entry | pdf

FSD Chimaphila umbellata Assessment Report (second consultation) | pdf

FSD Chimaphila umbellata List Entry (second consultation) | pdf

Templates for Public Consultations

First Safety Dilutions (FSD) subgroup

Homeopathic Use

Guidance documents - Notice To Applicants

Guidance documents on Quality

Guidance documents on Safety

Guidance documents on homeopathic use

Reports from meetings

  • 5-6 June 2014, Paris (France): report | pdf
  • 21-22 November 2013, Bonn (Germany): report | pdf
  • 30-31 May 2013, Dublin (Ireland): report | pdf
  • 23 October 2012, Gdansk (Poland): report | pdf
  • 5-6 June 2012, Copenhagen (Denmark): report | pdf
  • 7-8 June 2011, Budapest (Hungary): report | pdf