HMPWG: updated report on the regulatory status of homeopathic medicinal products

The Homeopathic Medicinal Product Working Group (HMPWG) of the Heads of Medicines Agencies has published an updated report on the regulatory status of homeopathic medicinal products for human use. It includes answers from the national competent authorities to 36 questions, mostly concerning homeopathic medicinal products but including some specific questions on anthroposophic medicinal products, providing an invaluable summary of the regulatory situation for these products in the EU and EFTA markets.

The original report (2017) was based on data from 2016 and included responses from 27 countries. The updated report is based on data collected between June and November 2022 and includes information on 29 countries, including, for the first time, Poland and Spain. Information on Cyprus and Portugal in the new report is based on the answers from 2016 only. Neither the UK nor Estonia are included in either report.

Most of the questions asked in 2016 have been asked again in the updated version and a number of new topics have also been addressed. Where the information has not changed, the answers reported are the same as in the previous report.

Part 1 of the report includes questions already present in the 2017 report, with updates where necessary –  that is questions on the marketing of homeopathic and anthroposophic medicinal products, on the implementation of Directive 2001/83/EC, on the specific national regulatory status of homeopathic medicinal products and on the national experience of registering or authorising homeopathic medicinal products.

Part 2 addresses new topics – specifically sale at a distance to the public, advertising, the name of the homeopathic medicinal product, the application of article 52a (importation or production of active substances used for homeopathic medicinal products), and the implementation of mandatory use of electronic common technical documents (eCTD) for registered homeopathic medicinal products.

ECHAMP welcomes this updated report, which provides comprehensive reliable regulatory information for our sector.