Assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products - Scientific guideline

This guideline describes the legal background and recommendations for the assessment of data that are used to prepare European Union herbal monographs (formerly called Community herbal monographs) on herbal medicinal products and the European Union list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products. The areas of herbal medicinal products with well-established medicinal use and traditional herbal medicinal products are addressed.

Keywords: Herbal medicinal products, clinical safety, efficacy, traditional use registration, marketing authorisation, European Union herbal monographs, European Union list of traditional herbal substances, preparations or combinations thereof