Regulation

The authorisation for a homeopathic medicinal product to be present on the market in the EU is regulated by specific provisions in Directive 2001/83/EC on medicinal products for human use, completed with specific provisions on the proof of quality and safety in Directive 2003/63/EC.

The overall picture for the regulatory status of anthroposophic medicinal products in the EU is very fragmented; Directive 2001/83/EC Article 1.5 as enlarged by ‘Recital 22’ defines that the legal basis of homeopathic medicinal products applies equally to all anthroposophic medicinal products that are homeopathically manufactured; other anthroposophic medicinal products are covered by the legislation for traditional herbal medicinal products as defined in Articles 1.29 and 16a (1) of the Directive. A number of limitations exclude the large majority of anthroposophic medicinal products from this simplified registration.

Implementation and enforcement of European medicines legislation for this sector has been slow and is very incomplete even twenty years after the publication of the first specific legislation, Directive 92/73/EEC, on homeopathic medicinal products, consolidated within Directive 2001/83/EC in 2001. Divergent implementation, interpretation and enforcement policy in the Member States make it extremely difficult for companies to operate across Europe.

ECHAMP’s study, The Availability of Homeopathic and Anthroposophic Medicinal Products in the EU finds modest to high demand for homeopathic and anthroposophic medicinal products in at least two thirds of the EU Member States. At the same time, the slow progress of enforcement of the relevant articles of Directive 2001/83/EC both seriously limits present availability and raises a question mark over sustained future availability of these products as well.

"Regulation is the limiting factor between the strong demand for these products, made visible across the EU, and true patient choice."
Dr Gesine Klein, President, ECHAMP

'The Availability of Homeopathic and Anthroposophic Medicinal Products in the EU' ECHAMP 2012