Traditional herbal medicinal products
Directive 2004/24/EC provides a special registration procedure for those herbal medicinal products with long tradition and an acceptable level of safety which do not fulfill the requirements of a well-established medicinal use in the meaning of Directive 2001/83/EC. Since many of the 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.
Herbal medicinal products subject to traditional-use registration according to Directive 2004/24/EC have to fulfill certain provisions:
- they have indications intended for use without the supervision of a medicinal practitioner
- they are an oral, external or inhalation preparation
- their efficacy is plausible on the basis of safe long-standing use and experience throughout a period of at least 30 years including at least 15 years within the EU.
The long tradition of these medicinal products makes it possible to reduce the need for preclinical and clinical trials.
However, requirements regarding their manufacturing and quality are equal to conventional medicinal products.
Directive 2004/24/EC was seen as the first step in the harmonisation of rules applicable to traditional medicinal products in Europe starting with medicinal products containing herbal substances. 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.