Homeopathic medicinal products are not subject to authorisation following Directive 2004/24/EC ¹ on Traditional Herbal Medicinal Products. However, since the majority of pharmaceutical companies producing homeopathic and anthroposophic medicinal products are also active in the sector of herbal medicine, the Directive is relevant. In addition, Directive 2004/24/EC amending Directive 2001/83/EC leaves room for expansion of its scope to other traditional medicinal products.

In principle, every application for a marketing authorisation has to contain the results of tests and trials on quality, safety and efficacy of the product. There are however some exceptions. The particulars relating to safety and efficacy need not be presented, e.g. where it is demonstrated by detailed references to published scientific literature that the product has a well-established medicinal use in the sense of Article 10(1)(a)(ii) of Directive 2001/83/EC, and as defined in Part 3 of Annex I to that Directive (as amended by Directive 2003/63/EC).

The legal framework for well-established use is suitable for certain herbal medicinal products. However, sufficient published scientific literature is not available for many (herbal) medicinal products, which have been used for a long period of time. For those products, well-established medicinal use cannot be demonstrated.

New tests and trials are in theory possible, but lead to significant financial burdens for the companies concerned – often small or medium-sized enterprises. Where the traditional use of a medicinal product is of such a nature that sound conclusions on safety and effectiveness can be drawn, it is disproportionate to require the abovementioned tests and trials for theoretical reasons only.

The legal situation and administrative practices regarding traditional (herbal) medicinal products in the Member States vary significantly. This has a negative impact on the protection of public health as well as on the free movement of these goods within Europe.

Against this background, Directive 2004/24/EC provides a special registration procedure. It allows registration and consequently marketing of certain traditional herbal medicinal products without requiring particulars and documents on tests and trials on safety and efficacy. However, requirements regarding the manufacturing of these products and their quality are equal to conventional medicinal products.

Directive 2004/24/EC for the first step in the harmonisation of rules applicable to traditional medicinal products in Europe starting with medicinal products containing herbal substances. It intends to contribute to the facilitation of the free movement of these products in the Internal Market. The specific provisions on traditional herbal medicinal products are now introduced under Article 16a to 16i in Directive 2001/83/EC on the Community code relating to medicinal products for human use.

According to Article 16i of Directive 2001/83/EC, the Commission would submit a report on the application of the rules on traditional herbal medicinal products to the European Parliament and Council before 30 April 2007. The inclusion of traditional medicinal products other than herbals should be clearly contemplated in this report. On the 30 May 2007, the Draft Report was published on the Pharmacos website of the Commission for consultation. Interested parties send in their comments before the 10 August 2007. The Draft Report points to 3 potential fields to which traditional use registrations could be extended: Anthroposophic medicinal products, Ayurvedic medicinal products, and Traditional Chinese medicinal products. 

¹ Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 136/85 [2004].