Anthroposophic Medicinal Products

Anthroposophic medicinal products (AMPs)

The Situation in Europe (July 2012)

(read also: "Should Anthroposophic Medicinal Products Be Regulated in Europe?" by
Geneviève Michaux

Anthroposophic medicinal products are on the market in certain EU member states under registration procedures that predate EU framework legislation for medicinal products for human use.

The EU Community Code relating to medicinal products for human use does not recognise AMP, whereas it does, for example, recognize homeopathic MP via special simplified registration procedures. This has far-reaching consequences for marketing authorisation and registration of AMP within the European Community. Only one third of AMPs – those manufactured in accordance with homeopathic pharmacopoeias - and another third of AMPs – those which meet the criteria for traditional medicinal herbal products (restricted however to oral or external use without indication) - can be registered under simplified registration procedures. Under procedures of the Community code relating to medicinal products for human use, over 40 percent of AMP - encompassing the majority of AMP prescribed by doctors, with indications, and administered other than orally or externally - require market authorisation similar to that for conventional pharmaceutical products. These procedures, however, do not take account of the special features and manufacturing methods of AMP, and are therefore not appropriate.

The “Vademecum of anthroposophic medicines” comprises indications for over 550 anthroposophic medicines based on physicians’ clinical experiences.

ESCAMP: ESCAMP is an international cooperative of researchers and experts in the field of anthroposophic medicinal products

Definitions of an Anthroposophic Medicinal Product (AMP) in German and Swiss pharmaceutical law

Last update 13.7.2016 ©IVAA 2016


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