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The legal basis for the authorisation of traditional herbal medicinal products

The amendments to Directive 2001/83/EC came into effect on 1 November 2005 in all the member states of the European Union.
This allows traditional herbal medicinal products to be authorised as a medicinal product through a simplified procedure.

A condition for acquiring a marketing authorisation under the directive is that the herbal medicinal product must have been used in medical practice for at least 30 years prior to the application date, and it must have been used in the European Union for at least 15 of those years. Furthermore, the product should only be used orally and/or externally and/or by inhalation, with an indication for use in conditions where a doctor is not required to establish the diagnosis, prescribe treatment or monitor the patient: in other words, exclusively for OTC indications.

Combinations with vitamins and minerals are permitted provided that the action of the vitamins and/or minerals can be shown to be ancillary to that of the herbal active ingredients regarding the specified indication.

Under Directive 2001/83/EC, herbal medicinal products that have already gone through the normal marketing authorisation procedure cannot be listed as traditional herbal medicinal products. The pharmacological effects and efficacy of traditional herbs must be demonstrated on the basis of a long history of use and experience.

Terms and definitions
The active ingredients of herbal medicinal products exclusively consist of one or more herbal substances and/or herbal preparations. Herbal substances are whole, broken or cut plants, parts of plants, algae, fungi and lichens. A herbal preparation is a preparation that is obtained by subjecting herbal substances to treatments such as extraction, distillation, pressing, fractionation, purification, concentration or fermentation.

Supporting evidence for traditional use
Traditional use must be demonstrated with bibliographic or expert evidence, for example using:

• marketing data, brochures, etcetera;
  
• references to manuals, such as the Farmacotherapeutisch compendium (J. van Hellemont), Pharmacotherapeutisch vademecum, old editions by Martindale, Rote Liste, Informatorium;
  
• official lists of licensed/authorised traditional herbal medicinal products in other member states of the European Union;
  
• reports from experts such as pharmacognosists, herbalists, doctors and pharmacists;
  
• national pharmacopoeias of member states that were used in the past, or the British Herbal Pharmacopoeia;
  
• Hoppe HA. Drogenkunde;
  
• List PH, Hörhammer L. Hagers Handbuch der Pharmaceutischen Praxis. Für Apotheker Arzneimittelhersteller Ärzte und Medizinalbeamte;
  
• Madaus G. Lehrbuch der biologischen Heilmittel.

The supporting evidence must show that product or a corresponding product has been used in medical practice for at least 30 years. Reference to a source published 30 years ago is not sufficient, as this simply demonstrates that the product was in use 30 years ago.

There must also be a connection between the duration of use and the claimed use. A corresponding herbal medicinal product may also be referred to in order to support the length of use claim. Here, 'corresponding' means that it has the same active ingredients (regardless of the excipients used), an equivalent concentration and posology, an identical or comparable intended effect and an identical or comparable method of administration.

If the composition of the product has changed, removal of substances is acceptable, but additions are not.