The Court of Justice of the Netherlands refered to the European Court of Justice to understand if the Directive on medicinal products for human use (2001/83) applies to anthroposophic medicinal products with regard to registration and authorisation.
The issue at stake is to decide whether there is scope for further national harmonisation or if the Community directive is exhaustive and closes the door to national initiatives.
Although anthroposophic medicines are not defined per se in the Directive, the Advocate General Yves Bots concludes that the Community directive is exhaustive and that anthroposophic medicinal products shall be covered by the registration and authorisation procedures laid down by the Directive 2001/83.
Three authorisation procedures are considered in the Directive:
One which applies to standard medicines, by which the provider needs to provide results of clinical trials, etc, unless the efficiency of the product can be proved by scientific evidence.
A specific procedure for homeopathic medicinal products with simplified registration and authorisation procedures
Specific simplified procedures of traditional herbal medicines.
According to the Advocate General, anthroposophic medicinal products do not fall under the category of homeopathic, nor traditional herbal medicines. He recommends that they are therefore to be considered under the same rules as ’standard’ medicinal products.
