Homeopathic Medicinal Products in Germany and Europe: Legal Requirements for Registration and Marketing Authorization

Abstract

Homeopathy has a long tradition and a well-established use in Europe, especially in France, the United Kingdom, and Germany. Homeopathic medicinal products are medicinal products as defined in Article 1 of the European Council Directive 65/65 EEC and in Article 2 of the German Medicines Act (AMG). The legal and terminological framework for homeopathic medicinal products in Germany and the European Union (EU) is laid down clearly in the European Pharmacopoeia, the European Council Directives 92/73 and 92/74 EEC and, on a national level, in the German Homeopathic Pharmacopoeia (HAB1). Homeopathic products may be registered without any indication claim or they may obtain a marketing authorization allowing indication claims.

Strict control of the safety of homeopathic medicinal products is necessary, because they may present risks. Therefore, homeopathic products should be included in pharmaco-vigilance systems. Safety requirements, however, should not be applied in a way that might discriminate against this particular therapy. The requirements should be adequate and proportionate. In Germany there is a strong political will to support homeopathy and to allow different schools of therapy. This is an expression of the pluralism of German society.

The acceptance of clinical indications on a European level depends greatly on the quality of clinical studies with homeopathic preparations which have to be performed in the future. The lack of such studies should not prevent agencies from investigating the market of homeopathic medicinal products. There is an indisputable need to protect public health. The best way to protect public health from risks associated with homeopathic medicinal products is to make well tested and adequately labeled products and reliable information available to the public.