EMEA workshop on homeopathic medicinal products concludes to strengthen harmonisation, but accept different national traditions

28 November 2006

The European Medicines Agency (EMEA) organised a workshop on homeopathic medicinal products on 27 October 2006 at the request of the European Commission. The aim of the workshop was to provide a forum for discussion among all stakeholders on the current legislative framework for homeopathic medicines. The workshop addressed strengths and weaknesses that have been identified, as well as potential threats and opportunities for improvement.

At the end of the one-day meeting, the participants concluded that the process of harmonisation should be strengthened, but that the different traditions in homeopathy in the EU Member States should be accepted. In addition, more experience with the registration procedures for homeopathic medicines within the current framework should be gained, with a view to maintaining availability of a broad range of homeopathic medicines.

The workshop brought together some 50 experts from industry, healthcare professional and patient associations, as well as regulatory authorities. The main topics of discussion were:

• The impact of recent revisions to homeopathic legislation on manufacturers, patients and healthcare professionals across the EU in terms of access, availability and affordability of homeopathic remedies, including anthroposophic homeopathic medicinal products;
• The challenges within the current regulatory framework as regards harmonisation and its limitations;
• Experience gained with the mutual-recognition procedure so far, and what can be learned from it for the future;
• The role, achievements and responsibilities of the Homeopathic Medicinal Products Working Group (HMPWG);
• The role of the European Pharmacopoeia in the development of monographs in the field of homeopathy.

The outcome of the workshop will be presented in a report to the European Commission, based on input provided by all parties attending.

Notes:

1. Once available, the report to the European Commission will be published on the EMEA website.
2. Presentations given by the participants will soon be made available on the EMEA website.

EMEA workshop on homeopathic medicinal products concludes to strengthen harmonisation, but accept different national traditions

Reference Number: EMEA/460146/2006