1. Herbal medicines

1.1. Definitions

A herbal medicine is defined as any medicine, exclusively containing as active ingredients:

  • one or more herbal substance(s)* or
  •  one or more herbal preparations**, or
  • a combination of the two.

*Herbal substances: All mainly whole, fragmented or cut plants, algae, fungi, or lichen in an unprocessed dried or fresh form, precisely defined by the plant part used and the botanical name

**Herbal preparations: preparations obtained from herbal substances after treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. Include powdered substances, tinctures, extracts, essential oils, juices and processed exudates.

See also: Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products (europa.eu)

Traditional herbal medicines form a specific group of herbal medicines, especially characterised by a long tradition of use and which do not fulfil the requirements for a marketing authorisation according to Directive 2001/83/EC, in particular because of a lack of sufficient scientific literature demonstrating a well-established medicinal use with recognised efficacy and an acceptable level of safety.