Eight monographs of the Homeopathic Pharmacopoeia are being revised

The Federal Institute for Drugs and Medical Devices (BfArM) hereby announces the recommendations of the Analytics Expert Committee of the German Homeopathic Pharmacopoeia Commission regarding the revision of eight monographs of the Homeopathic Pharmacopoeia (HAB). The announcement was signed in Bonn on August 19, 2026, and published in the Federal Gazette on September 14, 2026. Affected professional and commercial circles may submit comments until November 16, 2026.

Legal Basis and Procedure

The announcement is based on Section 8, Paragraph 5 of the Joint Rules of Procedure of the German Pharmacopoeia Commission and the German Homeopathic Pharmacopoeia Commission and their Committees dated October 1, 2025. According to these rules, the recommendations of the expert committees must be brought to the attention of the supreme state health and state veterinary authorities as well as the affected professional and commercial circles.

The revised draft monographs were recommended for inclusion in the Homeopathic Pharmacopoeia by the Analytics Expert Committee and are published as an annex to the announcement. The document bears the reference number 31.22-2026-23522 and is signed on behalf of Prof. Dr. Werner Knöß.

The Eight Revised Monographs

The revision concerns the following monographs:

• Artemisia absinthium (Absinthium)
• Chimaphila umbellata
• Disci intervertebrales bovis Gl (Disci intervertebrales cervicales, thoracici et lumbales bovis Gl)
• Drosera
• Galenit
• Graphites
• Hibiscus sabdariffa (Sabdariffa)
• Juglans regia (Juglans)

Essential Changes

The changes primarily concern identity and purity tests. For Artemisia absinthium, the non-specific odor was removed, the TLC method was switched to a toluene-free mobile phase, and a limit test for total thujone (maximum 0.035 percent, calculated as α-thujone) was added. For Chimaphila umbellata and Juglans regia, a limit test for total quinone derivatives, calculated as juglone, was added.

For Disci intervertebrales bovis Gl, the identity test was revised due to the discontinuation of the production of the previous ready-made gel for SDS-polyacrylamide gel electrophoresis. Additionally, botanical descriptions were adapted to current plant samples, and the scientific plant name was aligned with the Medicinal Plant Names Services database from Kew.

Deadline and Address for Comments

Comments on the drafts must be submitted by November 16, 2026, inclusive, to:

• the office of the Pharmacopoeia Commissions at the Federal Institute for Drugs and Medical Devices
• Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn

The announcement is of immediate importance to the homeopathic pharmaceutical industry and pharmacies, as the revised monographs will bindingly establish the quality and testing standards for the affected raw materials and mother tinctures upon entering into force. The opportunity to submit comments ensures that the affected groups can participate in the standard-setting process.

Source: Bundesanzeiger, BAnz AT 14.09.2026 B5, Announcement of a notification regarding the Homeopathic Pharmacopoeia, pp. 1–15 (official reference: 31.22-2026-23522).