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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 are:

  • quality
  • efficacy
  • safety

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.

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