Masterstudiengang "Drug Regulatory Affairs"


Comparison of the requirements in the registration and marketing authorisation procedure of human homoeopathic medicinal products within the EU with regard to specific requirements in Germany, Austria, the Netherlands and Switzerland as a Non-EU-country ***

Anja Kirsten Schiefer (Abschlußjahr: 2004)

According to the provisions of the Directive 2001/83/EC on the Community Code relating to medicinal products for Human use marketability of a homoeopathic medicinal product may be achieved through either a simplified registration or through a marketing authorisation procedure.
The simplified registration procedure provides simplifications with view to the dossier requirements: documentation on the clinical properties of the respective homoeopathic medicinal product need not be submitted to the competent authority. The requirements regarding the quality and safety documents are basically the same as for authorized homoeopathic medicinal products.

To be applicable in the simplified registration procedure, the homoeopathic medicinal product must meet several requirements as defined in article 14 of the Directive 2001/83/EC. First of all, it is not possible to market a registered homoeopathic medicinal product with therapeutic indications neither in the naming nor in any other information related to the medicinal product. Secondly, only dosage forms that are intended for oral or external use are applicable. Additionally, no homoeopathic ingredient must be of a higher concentration than one part in ten thousand of the mother tincture. In the case of substances that would have prescription status when used in allopathic medicines, the concentration must not be higher than 1/100th of the smallest allopathic dose.

This thesis aims to describe and compare both procedures with special regard to national-specific requirements. All selected countries (Germany, Austria, the Netherlands and Switzerland) have implemented simplified procedures. However, their requirements are still differing and inconsistent. The general restriction to”D4 and higher dilutions” of EU-law has not been transformed into German and Austrian national law. In both countries, as well as in Switzerland, the toxicological potential is assessed for each substance and due to this the permissible potencies are defined.

Harmonisation of the regulatory requirements in the registration procedure is still an ongoing process in Europe. The adoption of the general “D4-rule” of EU-law would not take account of national homoeopathic tradition, and therefore seems to be not reasonable.
This thesis makes proposals concerning a possible and sensible harmonisation.
Pages: 58

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