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A timeline: EU pharmaceutical regulation for homeopathic medicinal products 1992-2020

Feb 22, 2021

ECHAMP has published a new leaflet depicting the milestones in the EU regulation of homeopathic medicinal products since 1992.

Specific legislation for homeopathic medicinal products has deep roots in their broad use in the Member States. Even before the introduction of the first EU legislation in 1992, homeopathic medicinal products were prescribed and used in all Member States. In 1992, Directive 92/73/EEC created specific provisions for homeopathic medicinal products with the intention of creating a legal frame that would allow patients access to the medicinal products of their choice, while at the same time making sure that all precautions would be taken to ensure their quality and safety. The basic values for the legislation were free trade within the Community and freedom of choice for patients and the main motivation behind the legislation was the intention to safeguard quality and safety.

ECHAMP’s timeline provides an at-a-glance summary of the last thirty years of regulation for these products, detailing the relevant legislative acts, regulatory provisions, regulatory milestones and institutional reports, including those of the European Commission, the European Parliament and the Homeopathic Medicinal Products Working Group of the European Medicines Agency (HMPWG). The digital version of the document includes links to the relevant official documents on the web.

The timeline confirms that homeopathic medicinal products have a long-standing, solid legal framework in European pharmaceutical legislation, supported by high quality standards as defined in the European Pharmacopoeia.

Download the timeline from the ECHAMP website.