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;
To ensure reporting for the Heads of Medicines Agencies.

Rules of Procedure

Document adopted at HMA meeting in Dublin 30/01/2013, as amended by HMPWG at the 23^rd meeting in Utrecht 14-15/04/2016, the 29^th meeting in Bucharest 23-24/05/2019, the 34^th meeting in Paris 12-13/05/2022, by written procedure on 15/9/2022, and the 38^th meeting in Bruges 25-26/6/2024

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-SecretariatnoSpam@noSpamhmanoSpam.eu

Template for submission of request to HMPWG | word
Adopted by HMPWG on 18 October 2018
Guidance document on submission of request to the HWPWG | pdf
Adopted by HMPWG on 31 May 2018

Reports

Reports from meetings

18 October 2023, Virtual, Vienna (Austria): report | pdf
Adopted in June 2024
29-30 March 2023, Uppsala (Sweden): report | pdf
Adopted in October 2023
27-28 October 2022, Rome (Italy): report | pdf
Adopted in March 2023
12-13 May 2022, Paris (France): report | pdf
Adopted in October 2022
10 November 2021, Ljubljana (Slovenia): report | pdf
Adopted by written procedure in January 2022
28 January 2021, Lisbon (Portugal): report | pdf
Adopted by written procedure in April 2021
01-02 September 2020, Bonn (Germany) report | pdf
Adopted by written procedure in October 2020
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