[The technicoregulatory situation in France for manufactured homeopathic medications].
Many homeopathic medications are marketed in France on the basis of old national regulations: homeopathic medications with a common denomination (unit or complex products) whose former approval was transformed into a marketing authorization in 1984; "normal formulations" with a special denomination, often dating from before 1941 (date when drug approval was instituted) including certain produces whose marketing approval was obtained under different mechanisms but still sold today. After the EEC excluded homeopathic drugs from the "medication" directives, in 1975 the 92/72/EEC directive stated that beyond the normal requirements for quality and safety, the same obligations could not be required for homeopathic and allopathic medications. A "registration" system was thus instituted for "traditional" medications en lieu of marketing approval. This included a dual obligation: 1) abstention from claiming therapeutic indications, 2) avoiding any formulation which could carry a risk for the patients (i.e. oral and topical formulations exclusive and degree of dilution guaranteeing safety). Beyond this restrictive framework, these medications have marketing approval, but, for the specific features of homeopathic medications, the directive leaves it up to the member States with a "homeopathic tradition" to apply special rules for evaluating the results of clinical trials designed to establish safety and efficacy. For the efficacy feature, traditional use can be used as an argument for marketing approval (article R5143 CSP). In order to create a more rational technicoregulatory environment, older products marketed before 1994 are being "validated" by group according to a calendar established in 2003 and which should run from 2004 to 2012. At the end of this validation procedure, all manufactured homeopathic products will either receive marketing approval or be recorder in compliance with general or specific European regulations. In conclusion, we make a few personal comments which should be helpful for the reader to distinguish between therapeutic efficacy and therapeutic interest.
Santini
Cl
C
l'Académie nationale de pharmacie, 4, avenue de l'Observatoire, F75270 Paris Cedex 06.
D004345:Drug Industry / Q000331:legislation & jurisprudence; D005602:France; D007880:Legislation, Drug; D008419:Materia Medica / Q000592:standards*
D008419:Materia Medica