Homeopathic Medicinal Products Working Group (HMPWG)

Introduction/Mandate/Rules of Procedure

Introduction

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.

Rules of Procedure

HMPWG's Rules of Procedure | pdf

Document adopted at the HMA meeting in Dublin 30/01/2013, as amended by HMPWG at the 23rd meeting in Utrecht 14-15/04/2016 and the 29th meeting in Bucharest 23-24/05/2019.

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
  • Chair: Awaiting election

Contact

Contact Point:HMPWG-Secretariat@hma.eu

 

Reports

Reports from meetings

  • 24-25 October 2019, Bucharest (Romania): report | pdf
    Adopted by written procedure in December 2019
  • 23-24 May 2019, Bucharest (Romania): report | pdf
    Adopted in October 2019
  • 18-19 Oct 2018, Vienna (Austria): report | pdf
    Adopted by written procedure in February 2019
  • 17-18 May 2018, Berlin (Germany): report | pdf
  • 5-6 December 2017, Uppsala (Sweden): report | pdf
  • 26-27 June 2017, Gozo (Malta): report | pdf
  • 10-11 November 2016, Bern (Switzerland): report | pdf
    Adopted by written procedure in January 2017
  • 14-15 April 2016, Utrecht (The Netherlands): report | pdf
    Adopted by written procedure in June 2016
  • 11-12 November 2015, Utrecht (The Netherlands): report | pdf
    Adopted by written procedure in January 2016
  • 28-29 May 2015, Strasbourg (France): report | pdf
  • 4-5 December 2014, Rome (Italy): report | pdf
  • 5-6 June 2014, Paris (France): report | pdf
    Revision to Public 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

Other reports

Public Consultation

Documents for public consultation

Currently there are no documents undergoing public consultation.
 

Templates for Public Consultations

 

General Guidance/Regulatory and Legal issues/Notice to Applicants

General Guidance

Notice to Applicants

 

Subworking Groups

Quality

Homeopathic Use

First Safe Dilutions

 

Guidance documents on Quality

The documents in this section are also valid for veterinary homeopathic medicinal products as far as applicable.

Guidance documents

Questions and answers

Overview of comments

Guidance documents on Homeopathic Use

Guidance documents

Overview of comments

 

Guidance documents on Safety

Guidance Documents

First safe dilutions

Questions and answers

Overview of Comments/Further Information

Templates for HMPWG

Overview of comments

First Safe Dilutions AR