Herbal medicinal products in the European Union - AESGP

Belgium
Plants not native to Europe such as ginseng are regulated. There is no specific regulation
for less common plants, and they are considered on a case-by-case basis. The Ministry of
Public Health is very cautious with these herbs. However, many products are marketed i n
health stores.
There have been problems with non-occidental products (e.g., imported Chinese herbs) that
were analysed according to the Chinese Pharmacopoeia and declared to be conform. Now the
pharmacopoeia referred to must have modern scientific value. In addition, there have been
problems with Chinese plants whose microscopy and macroscopy were described for the
whole plant while the imported plants were in powder form, making performance of the
required tests impossible.
Denmark
Plants that do not have a well-established use cannot normally be authorised as natural
remedies. There is no definition of “well-established”, but it is understood that the use must
be within Western Europe. The supporting bibliographic material must be based upon
published scientific studies.
Finland
According to the definition of herbal medicinal products, products containing Chinese or
South-American herbs with or without medicinal indication cannot be classified as herbal
medicinal products because they have no medicinal tradition in Europe (or countries like
Europe).
Products containing plants that are not native to Europe (e.g., some Chinese or South-
American herbs), herbs used in Traditional Chinese Medicine (TCM) and plants that have
no European healthcare tradition are not classified as herbal medicinal products. Instead,
they are treated as normal medicinal products under Council Directive 65/65/EEC if they are
marketed with medicinal claims. A full application becomes necessary.
There is a problem with products on the market containing Chinese herbs which are sold
without medicinal claims. At the moment, most of these are sold as health products or food
supplements under the Food Act.
France
The assessment of products based on plants non-native to Europe must comply with the
Community legislation. The quality of the plant should be controlled according to the
standards of the French or the European Pharmacopoeias.
With regard to medicinal products, a full dossier is required for any plant that would not be
on the positive list (see point VII.2.7). With regard to magisterial preparations, it is possible
to obtain preparations containing non-native herbs with a medical prescription. In this case,
and the pharmacist is responsible for the pharmaceutical quality of the raw material used i n
the preparation.
Germany
If preparations of plants non-native to Europe are marketed as finished products, they are
regarded as “new entities” and must fulfil the complete requirements concerning quality,
safety and efficacy, particularly in terms of toxicological data and clinical documentation.
There is no specific regulation for crude herbal drugs that are not finished products.
Greece
Full proof of quality, safety and efficacy is required for plants non-native to Europe, i n
accordance with Council Directive 65/65/EEC.
71