In line with the general regulatory approach to pharmaceutical legislation, the primary aim of the Directive 92/73/EEC,¹ which came into force on the 1 January 1994, was the completion of the internal market. However, the second recital of the preamble indicates that the Directive essentially seeks to protect public health.² The Directive intends to take account of the specific characteristics of homeopathic and anthroposophic medicinal products which have been produced in accordance with a homeopathic manufacturing procedure.³ Therefore two procedures for market access of homeopathic and homeopathically produced anthroposophic medicinal products have been introduced:

1) Special Simplified Registration Procedure (Article 7 of Directive 92/73/EEC - Now Article 14 of Directive 2001/83/EC on medicinal products for human use⁴);

2) Marketing Authorisation (Article 9 of Directive 92/73/EEC - Now Article 16 of Directive 2001/83/EC).

The special simplified registration procedure applies to medicinal products produced in accordance with a homeopathic manufacturing procedure that comply with the following criteria

1) 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;

2) They are for oral or external administration;

3) 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 9 of Directive 92/73/EEC (Now Article 16 of Directive 2001/83/EC). 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 9(2) of Directive 92/73/EEC (Now Article 16 of Directive 2001/83/EC) 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. As all EU Member States have a homeopathic tradition,⁵ they are able to adopt special rules to make a risk/benefit assessment.⁶ Nevertheless, some Member States are not aware of their homeopathic tradition and have consequently not adopted special rules.⁷

The Commission stated in its Report on the application of Directive 92/73/EEC ⁸ in 1997 that the introduction of a Directive that harmonises the registration regime of homeopathic medicinal products did not remove the disparities between the national regimes in the Member States.⁹ Due to hesitant positions of certain Member States towards homeopathically produced medicinal products it was decided to amend Directive 92/73/EEC only slightly during its inclusion in Directive 2001/83/EC as part of the general codification of the EC pharmaceutical law. This process started in November 2001 by merging the existing Directives into one text. Since Directive 2001/83/EC mainly represented a re-codification of existing rules, it did not fundamentally change the rules for homeopathically produced medicinal products.

Subsequent revisions of Directive 2001/83/EC in 2003 and 2004 have brought about more substantive 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.¹⁰ Secondly, the review process of Directive 2001/83/EC that resulted in the adoption of Directive 2004/27/EC ¹¹ 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.

Despite the described harmonisation efforts, it should be emphasized that the regulation of homeopathic and anthroposophic medicinal products is still in a development stage 15 years after the adoption of Directive 92/73/EEC. A single market for homeopathic and anthroposophic medicinal products with an optimal balance between health protection and consumer choice has not yet become a reality. More effective and efficient harmonisation efforts are therefore indispensable for attaining this goal to the benefit of medicinal products representing a therapeutic tradition in Europe that is more than 200 years old.

An overview of the legislation, preparatory documents, and reports can be found here.