EMA publishes Draft Guideline on the Declaration of Active Substances in Herbal Drugs

On 1 April 2026, the European Medicines Agency (EMA) published the draft of the second revision of the Guideline on the declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products. The guideline establishes uniform principles for the declaration of herbal substances and herbal preparations when these are used as active substances in herbal medicinal products (HMPs) and traditional herbal medicinal products (THMPs). The aim is to ensure a harmonised, transparent and comprehensible declaration of the herbal active substances used in the marketing authorisation dossiers and in the product information.

The guideline focuses on correct presentation in the Summary of Product Characteristics (SmPC). Supplementary and detailed requirements regarding the package leaflet, labelling and other plant-specific aspects are contained in Annex 1.

Key changes

• Updated requirements for the declaration of extracts:
  In European procedures, both the genuine drug-to-extract ratio (DERgenuine) and the corresponding mass of the herbal drug are to be stated in the SmPC in future.
  
• Clarifications and extensions regarding the naming of herbal substances, the declaration of fresh and frozen drugs, extraction solvents, excipients and combination products.
  
• Editorial amendments to reflect current legislation, revised Ph. Eur. monographs and relevant EU guidelines.

The draft is open for comments until 30 June 2026. Further information can be found in the Draft 'Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products' - Revision 2.