There is a need for a regulatory framework for anthroposophic medicinal products (AMPs) in Europe. The existing regulatory requirements for conventional medicinal products are not appropriate for AMPs. Special registration procedures exist in some countries for homeopathic products and in the European Union for herbal products. However, these procedures only apply to a proportion of AMPs and the particular properties of AMPs are only in part accounted for. Suitable registration procedures especially for AMPs exist only in Germany and Switzerland.
The European Commission has acknowledged the existence of therapy systems, whose products have no adequate regulation, and it has proposed that the suitability of a separate legal framework for products of certain traditions such as Anthroposophic Medicine should be assessed [1,2]. This statement should be seen in the context of developments in international trade, whereby representatives of therapy systems such as Traditional Chinese Medicine and Ayurveda wish to market their products in Europe.
- Communication from the Commission to the Council and The European Parliament concerning the Report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC, as amended by Directive 2004/24/EC, on specific provisions applicable to traditional herbal medicinal products. Document on the basis of Article 16i of Directive 2001/83/EC. Brussels: Commission of the European Communities; 2008.
- Summary record of the 65th Pharmaceutical Committee meeting, 16th March 2009. European Commission, Enterprise and Industry Directorate-General. Consumer Goods Pharmaceuticals. Pharm 572. Brussels: European Commission; 2009
Last update: February 2012