herbal medicinal products
Herbal medicinal products, also known as phythotherapeutic
products, are medicinal products whose active ingredients are
exclusively plants, parts of plants or plant material, or
combinations thereof, in their natural or processed state.
Like all other medicinal products, herbal medicinal products
require marketing authorisation. This means that they can only be
placed on the market after receiving marketing authorisation from
the Medicines Evaluation Board (MEB).
The legal criteria that the MEB uses in order to come to a decision
As far as efficacy is concerned, an exception is made for herbal
medicinal products with a long tradition of use in the European
Union: these products are known as traditional herbal medicinal
products. The efficacy of these products is assessed not by
clinical testing but on the basis of a
long history of use and experience.
All other medicinal products, including non-traditional herbal
medicinal products, have to be proven to be effective before they
can be authorised.