Homeopathic medicinal products European regulations
European regulations (Directive 2001/83/EC amended by Directive 2004/27/EC) for the simplified registration of homeopathic preparations, provided they are manufactured according to a procedure defined in the European Pharmacopoeia (EP) or – in cases where the procedure is not yet included in the EP, in a national homeopathic pharmacopoeia such as the German or the French homeopathic pharmacopoeias. The registration procedure is not harmonised, registrations are purely national, and applications may thus be treated differently between EU Member States. No medical indications are allowed on the product labels, as homeopathy is a highly individualised therapy.
Full set of data on the quality of materials
Licensing requires a full set of data on the quality of the materials used in manufacturing. This includes data on the whereabouts of the herbal starting materials according to GACP (Good Agricultural and Collecting Practice) standards. These standards are frequently difficult to meet, as homeopathy usually requires only small quantities of plant material as starting substances, and the administrative burden in this context may easily exceed the economic benefit. This is especially difficult for plant materials included in Annex II of the CITES list.
Similarly, materials obtained from animals (e.g., ants, spiders, bees etc.) are now practically impossible to obtain. In the case of animal-derived materials it is not only the practical aspects and administrative burdens of sourcing, but also increased requirements with respect to quality and safety, e.g., safety with respect to transmissible diseases (viral infections, transmissible spongiform encephalitis etc.), which render the whole process of manufacturing uneconomic.
Stability data of drug substance and drug product
The registration of homeopathic preparations also calls for stability data for both the drug substance and the drug product. The corresponding guidelines of the European Medicines Agency are fully applicable. Practical application of the guidelines by the authority now leads to a questioning of the quality and stability of stocks of homeopathic starting materials and intermediate potentisations (technically dilutions).
The costs of stability testing aside, even in cases where the dilution level does not allow detection of the physical presence of the original starting material, the mandatory application of these rules adds to the cost of supplying starting materials so that production of these medicines is no longer an economic proposition. Ultimately manufacturers will either have to cease manufacturing many classical homeopathic preparations or increase the price to an unaffordable level. Both options will severely restrict the availability of homeopathic preparations.