Directive 2001/83/EC on medicinal products for human use has introduced two procedures for market access of homeopathic medicinal products:
- Special Simplified Registration Procedure - Article 14;
- Marketing Authorisation - Article 16.
The special simplified registration procedure applies to medicinal products produced in accordance with a homeopathic manufacturing procedure that comply with the following criteria
- They do not contain more than 1:10,000 part of the mother tincture or 1:100 part of the smallest dose of a substance that is used in allopathic medicine, and for which a doctor’s prescription is required;
- They are for oral or external administration;
- They do not bear a specific therapeutic indication.
Those products which do not comply with these criteria need to be authorised in accordance with Article 16. As a consequence, the general licensing procedures for allopathic medicinal products are in principle applicable to homeopathically produced medicinal products which are not eligible for a special simplified registration. Member States have however the competence under Article 16 to modify the requirements for pre-clinical tests (pharmacological and toxicological tests) and clinical trials in accordance with the principles and characteristics of homeopathy as practiced in the particular Member State.
Subsequent revisions of Directive 2001/83/EC in 2003 and 2004 have brought about some modifications. Firstly, Directive 2003/63/EC has inserted specific provisions on the proof of quality and safety of homeopathic medicinal products in the amended Annex I of Directive 2001/83/EC providing more clarity for the assessment of applications. Secondly, the review process of Directive 2001/83/EC that resulted in the adoption of Directive 2004/27/EC may lead to a step forward with the inclusion of the mutual recognition and decentralised procedures. The scope of the mutual recognition and decentralised procedures is restricted to products entitled to a special simplified registration. Another potential improvement is the possibility under Article 14(1), paragraph 2, to change the arbitrary and unscientific dilution requirement of 1:10,000 for the special simplified registration procedure by means of a specialist committee.