European Union legal models

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First of all it is necessary to make a clear statement regarding products containing plant derivatives. The pharmaceutical approval scheme has been designed for pure chemical compounds. For this reason it is actually very difficult to register a herbal medicine, collecting all the data needed for the marketing authorization. This is true if the herbal medicine is a multi-compound product, like an extract. But it is false if a single compound, which is the sole cause of the pharmacological effect, has been isolated from the herbal derivative. In this case, the normal pharmaceutical registration way does not present any insurmountable obstacle and there are no reasons not to follow it. The product is always a plant derivative, but as a single compound it is very similar to a new chemical entity. A good example is the oncological products obtained from Taxus baccata.

Basically, herbal products are regulated under food law or under pharmaceutical law sometimes with a simplified pharmaceutical registration dossier. The major trend in the member states is to regulate herbs as medicines with the possibility of a simplified pharmaceutical registration procedure. To obtain marketing authorization it is enough to get a bibliographical dossier of the pharmaco-toxicological and clinical aspects and good chemical and pharmaceutical documentation demonstrating the safety and quality of the product. Following this trend the European Commission is preparing a directive on traditional herbal medicines. Herbal products marketed in Europe for more than 30 years, can be registered with an abridged dossier. The safety of the product is based on the 30 years' safe usage and efficacy and does not have to be proven.

The other very strong trend, but not at the European level, is the inclusion of herbs in positive or negative lists. This means that herbs included in (or excluded from) the lists can be sold under food law and the others are regarded as medicines. Some countries, even if the herb is considered a food, require a notification with the health ministry prior to marketing.

The European Parliament is preparing a food supplements directive. The impact of this directive on herbal products is, as a matter of fact, not very clear. At the beginning the directive regulated only vitamins, minerals and amino acids, but now it is applicable even for substances capable of having a physiological action on the body, not dependent on its nutritional properties. The physiological function can imply that even certain herbal products shall be deemed as food supplements. The directive proposal has an annex with a positive list of vitamins, minerals and amino acids that can be contained in a food supplement. The Scientific Committee on Food will be competent to evaluate which substances to add to the list in a five-year time frame. In this time frame substances not present in the list can be marketed on a national basis.

Starting now our little tour of the member states' regulations for herbal products, we will examine the legal framework, distribution channel and the real marketing practice of the most significant (in population size) countries.

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