Masterstudiengang "Drug Regulatory Affairs"


Regulatory requirements concerning the quality of herbal medicinal products under the EU pharmaceutical and national food legislation ***

Dr. Carolin Notheis (Abschlußjahr: 2001)

Herbal medicinal products are medicinal products containing exclusively herbal drugs or herbal drug preparations as active substances.

In Germany and some other EU member states, herbal remedies enjoy great popularity, particularly in the over-the counter (OTC) sector. In most cases, herbal medicinal products are only marketed in one member state, based on a national marketing authorisation. The national marketing authorisation is often issued based on a simplified proof of safety and efficacy, taking into account the "traditional use" of herbal medicinal products.

Only very few products have successfully used the European mutual recognition procedure to obtain marketing authorisation in more than one member state, mainly due to differences in the legal systems of the member states, as far as bibliographic application or simplified proof of efficacy.

The criteria for the quality of herbal medicinal products are harmonised. They are laid down in the European Pharmacopoeia and in the "Rules Governing medicinal products in the EU", among them the Annex of Council Directive 75/318/EEC, part II of the Notice to Applicants, and several Quality Guidelines.

The thesis presents these requirements on the quality of herbal medicinal products taking into account all relevant EU and German national regulations.

A second part of the thesis deals with products from medicinal plants with a health related claim sold as "food". The classification of herbal products as medicinal product or food is not harmonised throughout the EU. There are products that fall under the definition of medicinal products in Germany, but are regarded food in the Netherlands. These products can be marketed in Germany by means of general order acc. to § 47a LMBG (German Law on Foods an d commodities).

There is a growing tendency in marketing products from medicinal plants outside the scope of pharmaceutical regulations as food products, such as food supplements, functional food, dietary food or nutraceutical. These products can be marketed without approval, but also have to fulfil certain requirements concerning "quality". A short comparison opposes the quality requirements according to Notice to Applicants to the corresponding requirements under the food legislation.

Pages: 33