The legal status of anthroposophic medicinal products within the framework of pharmaceutical legislation in the EU is less clear-cut than that of homeopathic medicinal products. In most cases medicinal products used within the anthroposophic medical tradition cannot be distinguished on the basis of their methods of production, as these are largely shared with other medicinal product groups such as homeopathic and herbal medicinal products. In case of overlap, anthroposophic medicinal products are legally qualified as homeopathic or traditional herbal medicinal products as mentioned in Articles 1(5) and 1(29) of Directive 2001/83/EC.¹ In case these specific categories do not apply, anthroposophic medicinal products are covered by the general definition of medicinal product as laid down in Article 1(2) of Directive 2001/83/EC.²

The general definition and related authorisation procedures are implemented very differently by the Member States in respect of anthroposophic medicinal products, which leads to trade barriers and legal uncertainty. In this context, the Draft Communication Report from the Commission on specific provisions applicable to traditional herbal medicinal products ³ does not point to a harmonised solution on the basis of an ‘extension’ of the ‘traditional use’ registration in the coming years. The practical consequence of this is a de facto prohibition of non-homeopathic or non-traditional herbal anthroposophic medicinal products in certain Member States.