BfArM presents eight revised monographs of the Homoeopathic Pharmacopoeia

The Federal Institute for Drugs and Medical Devices (BfArM) has taken note of the recommendations of the Analytics Expert Committee of the German Homeopathic Pharmacopoeia Commission regarding eight revised monographs for inclusion in the Homeopathic Pharmacopoeia (HAB). The announcement was published on September 14, 2026, in the Federal Gazette under the official reference BAnz AT 14.09.2026 B5 and is dated August 19, 2026. Affected professional and business circles may submit comments until November 16, 2026.

Legal Basis and Procedure

The publication 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 this, recommendations from the expert committees must be brought to the attention of the supreme state health and veterinary authorities as well as the affected professional and business circles. The announcement was signed on behalf of Prof. Dr. Werner Knöß and bears the reference number 31.22-2026-23522.

The Eight Revised Monographs

The Analytics Expert Committee has recommended the drafts of the following revised monographs for inclusion in the Homeopathic Pharmacopoeia:

• 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 revisions primarily concern the identity and purity tests of the mother tinctures and triturations. For Artemisia absinthium, the thin-layer chromatography was switched to a toluene-free mobile phase, and a limit test for total thujone (maximum 0.035 percent, calculated as α-thujone) was newly added. For Chimaphila umbellata, Drosera, and Juglans regia, the content of total quinone derivatives will in future be calculated using single-point calibration instead of the specific absorption of juglone; for companies that have already begun stability studies, the committee has determined a conversion factor. For Disci intervertebrales bovis Gl, the identity test was revised due to the discontinuation of a ready-made gel for SDS-polyacrylamide gel electrophoresis, and for Galenit and Graphites, the testing methods and specifications were further specified.

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 addressed in particular to manufacturers of homeopathic medicinal products who must adapt their mother tinctures and triturations to the revised quality requirements. The revised monographs thus ensure the quality of the medicinal products and the comparability of the testing methods in the Homeopathic Pharmacopoeia.

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