European Union directives and their effect on the registration and authorisation of...

This paper discusses the question of whether anthroposophic medicinal products can be treated in the European Union as regards registration and marketing authorization, in the same way as homeopathic medicinal products. European Union legislation, European official pharmacopoeias, and bibliography in this regard have been revised. European Directives make a single reference in one of its whereas clauses to anthroposophic medicinal products "described in an official pharmacopoeia and prepared by a homeopathic method". It is referring to those which comply with these two conditions, but it happens that there is no anthroposophic medicinal product "described" in any European official pharmacopoeia. Legislators have known this and continue to be aware of it and have not agreed to extend (since 1992), the reference to anthroposophic products neither do they accept the inclusion of that peculiarity on the label of homeopathic medicinal products. Anthroposophy presents notable variations from homeopathy and it introduces philosophical and "spiritual" variables that are difficult to assess objectively. It is necessary for these products to show, using a scientific methodology, that they are truly bringing patients the therapeutic benefits they claim. In any case, their authorization and registration should not be at the expense of homeopathy, already a highly complex field in its own right.

Med Law. 2009 Mar;28(2):269-82. Laso LR, Alfonso-Galán MT. Spanish Agency of Medicines and Healthcare Products.