Answer given by Mr Dalli on behalf of the Commission
Where a homeopathic product fulfils the definition of medicinal product as established in Directive 2001/83/EC(1), it needs a marketing authorisation or a registration to be placed on the EU market.
Homeopathic products bearing a therapeutic indication are subject to the requirement of a marketing authorisation as established in Directive 2001/83/EC. The requirements to be fulfilled by the applicant include, among others, pre-clinical tests and clinical trials to demonstrate safety and efficacy of the homeopathic medicinal products, as requested for the marketing authorisation of any other medicinal product.
However, since the beginning of the 1990s(2), the pharmaceutical acquis has provided for a simplified registration procedure for specific homeopathic medicinal products. The simplified procedure allows the registration of homeopathic medicinal products without requiring particulars and documents on tests and trials on safety and efficacy, provided that they are administered orally or externally, no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto, and that there is a sufficient degree of dilution to guarantee the safety of the medicinal product.