St. John's Wort: Updated EU Herbal Monograph

Recommendation

5/6 June 2024

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

The updated final EU herbal monograph on St. John's wort has been published. In addition to the monograph, the associated supporting documents (HMPC Opinion, Assessment Report and List of References) and an overview of the comments received on "well-established use" and "traditional use", respectively, have been published.

Changes to the Monograph

The following changes have been introduced:

• Changes regarding "well-established use":
  Information on contraindications, interactions, pregnancy and lactation, adverse drug reactions, pharmacokinetics, and preclinical information has been clarified.
• Changes regarding "traditional use":
  A new expressed juice preparation with the traditional indication "for the symptomatic relief of mild gastrointestinal discomfort" was included, as was a new indication "Traditional herbal medicinal product for the supportive treatment of nervous restlessness and associated with difficulties in falling asleep" for the comminuted herbal drug. For preparations with hyperforin content > 1 mg, concomitant use of drugs with CYP interaction potential is a contraindication. The "Interactions" section has been clarified for these preparations, as has the pharmacokinetics section. Furthermore, the preclinical safety data have been supplemented.

All documents are available on the "Hyperici herba" page.