Masterstudiengang "Drug Regulatory Affairs"


Comparison of the requirements for simplified registration and marketing authorization procedure of homeopathic products with Austria, France, Germany, Italy and Switzerland

Elvira Holder (Abschlußjahr: 2007)

The thesis compares homeopathic regulations of European Union (EU)- Member States along the Swiss border with Switzerland as a non-EU country. After years of discussions and professional activities within the EU, the legislation eventually evolved on EU – level. With Directive 2001/83/EC, as amended in 2004, two different regimes to register respectively authorise homeopathic medicinal products became possible in the EU.  A „Simplified Registration Procedure“ (SRP) and a “Marketing Authorization Procedure”. The „simplified“ refers to lower requirements on toxicological and clinical data. Due to these lower requirements, several constraints have been implemented: Only active ingredients equal or higher than D 4 dilution (1:10'000) in the final product are permitted. It is only allowed for topical and oral administration and labelling of indications is not permitted. The “SRP-products” can apply for the „Mutual Recognition Procedure“ (MRP). However, there is a limitation on the MRP in case of a „Serious Risk to Public Health Concern“: It only will be referred to the “Co-ordination Group for Mutual Recognition and Decentralized Procedures” (CMD) and it will not be transferred for an “Arbitration Procedure” to the “Commission of Human Medicinal Products” (CHMP). At least, the SRP has been outlined in the Directive 2001/83/EC and became binding for all EU- Member States in 2004 to be implemented into national law.
Whereas the second regime, the “Marketing Authorization Procedure“, was not defined with the enactment of Directive 2001/83/EC in 2004. It was decided to leave this for future revisions. Nevertheless the EU- Member States are authorized, to either keep already established regulations or to create new laws for “Marketing Authorization Procedure” on national level, taking the specific character of homeopathic medicinal products into account. All compared EU- Member States as well as Switzerland implemented laws for this type of licensing of homeopathic medicinal products. It allows for labelling of indications. The national laws of the EU-Member States however deviate considerably, thus making mutually recognized product authorizations impossible at this stage. This is why the thesis does not focus and evaluate in detail the marketing authorisation procedures of the respective countries.
Switzerland implemented the “Complementary and Phytomedicinal Regulation” (Komplementär- und Phytoarzneimittelverordnung, KPAV) on 1 October 2006 comprising these two regimes:  A simplified registration as well as a simplified marketing authorisation procedure. The “simplified registration procedure” was split up in two sub-procedures: a “listing procedure”  (“Meldeverfahren”) and a “registration procedure without indication based on a reduced dossier” (“Vereinfachte Zulassung ohne Indikation mit reduziertem Dossier”). Amongst several constraints for the allowed dilution level for either of the simplified registration sub-procedures, they both do not qualify for labelling of indications. The simplified marketing authorisation, as mentioned above, allows for labelling of indications.
Taking the political environment  of Switzerland into account, the thesis will try to point out why the Swiss regulation on homeopathic medicinal products became the closest nationally implemented version of the ideas discussed and suggested on European level – at least until the next revision of the KPAV, which is already on its way. Switzerland did not only implement Directive 92/73/EC, it also took over the suggestions of the European Commission given in their report in 1997 almost one by one. The formal scope of the KPAV was not even increased to accommodate a very specific group of Swiss medicinal products at the interface of homeopathic and phytomedicinal products, which has been established and registered on a cantonal level since the 1980’s. In this way the KPAV came out to be the “most European regulation” on homeopathic medicinal products with quite demanding requirements for the simplified registration and the simplified marketing authorisation procedure.
Pages: 25