(2002; 166 pages)
The regulatory framework for homoeopathic medicinal products in Germany and in the European Union
Dr Konstantin Keller, Germany
Homoeopathy was founded in Germany by Dr Samuel Christian Hahnemann in 1796. It forms a substantial part of the health care system in Germany. Homoeopathic products are used in all member states of the European Union (EU), with Germany, France, Belgium and Austria accounting for 90% of the total estimated market of about US$ 230 million.
Homoeopathic products fall into the WHO definition of traditional medicine. Homoeopathy is fully integrated into the European pharmaceutical legislation. Under Council Directive 2001/83/EEC, homoeopathic products without any therapeutic claims may be registered through a simplified marketing authorization, whereas a full marketing authorization is required for those with indication claims.
Registration requirements include compliance with GMP and pharmacopoeias, evidence of homoeopathic tradition, mandatory labelling of the homoeopathic nature, and restrictions on the degree of dilution and dosage forms. Additional toxicological data or bibliographical data on the traditional use of the homoeopathic products may be required for full marketing authorization. Nonetheless, the directive allows member states to implement specific rules to address the national tradition and the particularities of homoeopathy for medicinal products with indication claims.
The European Pharmacopoeia is an important tool in the area of quality. It sets out clear definitions and monographs for homoeopathic preparations and the manufacturing procedures. The variety of starting materials of botanical, zoological, chemical and microbial origin warrants adequate assessment of safety, especially viral contamination. The safety of homoeopathic products is often overlooked, since they are perceived as being always highly diluted. However, this is not necessarily true and homoeopathic products may contain toxic substances in considerable quantities.