European Union
In 1992, the Council of the European Communities stated in the preamble to a directive that homeopathy was officially recognized in certain member states but only tolerated in others. In any case it was prescribed and used in all member states. To harmonize the market of homeopathic products, the council, by Directive 92/73/EEC directed the member states to implement certain changes in their national legislation. Directive 92/73/EEC was replaced by Directive 2001/83/EC on the Community code relating to medicinal products for human use
Member states are required to ensure that homeopathic products (for oral or external use) can be registered without proof of therapeutic efficacy, provided that there is a sufficient degree of dilution to guarantee the safety of the product; in particular, the product may not contain either more than one part per 10,000 of the mother tincture or more than 1/100th of the smallest dose used in mainstream medicine, with regard to active principles whose presence in a medicinal product results in the obligation to submit a doctor's prescription. In other words, the dilution must be at least D4/4X/C2, and even higher in special cases. Other homeopathic products can still be registered under the normal rules, and products such as Arnica D1 are legally available.
The labels of homeopathic products registered without proof of efficacy must include the words "homeopathic medicinal product without approved therapeutic indications" as well as "a warning advising the user to consult a doctor if the symptoms persist during the use of the medicinal product".
Read more about this topic: Regulation And Prevalence Of Homeopathy, Europe
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