Directive 2004/24/EC for traditional herbal medicinal products

Due to a given occasion and due to inquiries regarding "innovations" in the field of traditional herbal medicinal products, the Federal Office for Safety in Health Care takes the liberty to inform about the current legal situation. The background of the current discussions is not a "new document" of the European Commission, but the transitional provisions of Directive 2004/24/EC. Directive 2004/24/EC created for the first time in the European Community a harmonized simplified registration procedure for traditional herbal medicinal products. This is because certain herbal medicinal products are unable to meet the expected scientific requirements for proof of efficacy, or can only do so with difficulty. Therefore, the European legislator decided to consider the proof of efficacy for these particular medicinal products as plausible based on many years of use and experience.

This directive came into force on April 30, 2004, and the transitional provisions stipulate that the provisions of the directive are not to be applied to products approved nationally at that time until after seven years. In Austria, the relevant provisions were implemented as of 01.01.2006 with the amendment to the Medicinal Products Act by Federal Law Gazette I No. 153/2005 in Section 12 of the Medicinal Products Act. Since then, traditional herbal medicinal specialties can also be registered in Austria. In Austria, the aforementioned transitional provisions relate in particular to those herbal products that were authorized under Section 17a of the Medicinal Products Act (in the version prior to the amendment, Federal Law Gazette I No. 153/2005). For these, Section 94c (8) of the Medicinal Products Act stipulates that their authorization expires no later than the end of April 30, 2011, and that they may no longer be marketed as of May 1, 2011.

However, if the marketing authorization holder has submitted an application for marketing authorization or an application for registration as a traditional herbal medicinal product by October 30, 2010, the marketing authorization remains valid until the decision of the Federal Office for Safety in Health Care on the application for marketing authorization or the application for registration. Under Section 17a of the German Medicines Act, 743 medicinal products have been approved, with approximately 300 containing herbal active ingredients.

Finally, it may be pointed out that these regulations have no effect on herbal teas or other herbal foodstuffs marketed in accordance with the provisions of food law.

Queries:

Univ.-Doz. Dr. Reinhard Länger

E-mail: pr_pharmmed@ages.at