Marketing Authorization of Homeopathic Medicinal Product in Europe: An Overview
Abstract
Manish Mudaliar
The Council of the European Communities stated in the preamble to a
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directive that homeopathy was officially recognized in certain member
states. In any case it was prescribed and used in all member states. In
order to harmonize the market of homeopathic products, the council, in
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 by
skipping the 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 1/10,000th of
the mother tincture or more than 1/100th of the smallest dose used in
medicine, with regard to active principles whose presence in a
medicinal product results in the obligation to submit a doctor's
prescription.
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