Herbal medicinal products: Directive 2004/24/EC
The background to the recent discussions is not a 'new' document from the European Commission, but the 2004 Directive 2004/24 EC, which defines traditional herbal medicinal products and sets the regulatory framework for them across the EU. This innovation brought the opportunity for traditionally proven products to be on the market as medicinal products throughout the EU, provided they meet defined criteria. Key points for traditional her bal medicinal products
- At least 30 years of medical use (of which at least 15 years in the EU).
- Use must be possible without medical supervision.
- The application must be safe.
- The effect must be 'plausible', i.e. registration as a traditional herbal medicinal product is possible even without clinical testing.
- The quality of the products complies with the current guidelines
This directive was implemented in Austria in January 2006 with an amendment to the Austrian Medicines Act (AMG) (AMG §§12ff). Since then, traditional herbal medicinal products can also be registered in Austria. Situation before 2006 In Austria, as well as in many other EU member states, products that fulfilled certain requirements could already be registered in a simplified way before this date. In Austria, this was possible according to §17a of the former Medicines Act. Currently, 743 drugs are approved under this paragraph. In the interest of patient safety, all medicinal products should comply with current quality guidelines. Therefore, transitional provisions were defined for this group of medicinal products in Directive 2004/24 in Article 2: The competent authorities (in Austria the Federal Office for Safety in Health Care, BASG) must apply the provisions of this directive before the expiry ofseven years also to those simplified authorized medicinal products that are already on the market when this directive comes into force. This results in the end of the transitional period on 30.04.2011. For Austria, this means that the marketing authorization of medicinal products that were approved in a simplified way according to §17a of the previous version of the Medicinal Products Act expires at the latest on 30.04.2011 (stipulated in AMG §94c(8)). The marketing authorization holders have the possibility to submit an application for registration as a traditional herbal medicinal product. This way the product can remain on the market. List of medicinal products The BASG has published a list of those medicinal products on its website whose marketing authorization will expire on 30.04.2011 due to the above-mentioned provisions. This cut-off date therefore only affects a very specific group of medicinal products. This regulation has no impact on the food sector nor on the delimitation of food and medicinal products. Therefore, there is no obstacle to the use of herbal teas as foodstuffs in the future.
Magistral and officinal preparations
In addition, pharmacies are still allowed to produce and dispense magisterial and officinal preparations of all traditional remedies. A magisterial preparation is defined as a preparation made on the basis of a medical or dental prescription for a specific patient; an officinal preparation is defined as a preparation made in accordance with a monograph in the pharmacopoeia.
In addition, we would like to refer to the website of the European Commission. At the European level, too, efforts are being made to counteract the uncertainty of consumers and patients in connection with Directive 2004/24/EC.
Further information:
Further inquiries:
AGES PharmMed
Univ.-Doz. Dr. Reinhard Länger
E-mail: reinhard.laenger@ages.at
