This guideline applies to human and veterinary medicines.
This document outlines the principles for uniform declaration of herbal substances/preparations in herbal medicinal products as well as in traditional herbal medicinal products. It describes declaration in the summary of product characteristics (SmPC). Guidance on package leaflets, labelling and other herbal specific provisions for SmPC, package leaflets and labelling, have been added in Annex 1.
Keywords: Herbal medicinal products, traditional herbal medicinal products, herbal substances, herbal preparations, extracts, declaration, summary of product characteristics (SmPC), package leaflet, labelling