Revised German Cannabis Monograph

Recommendation
12/13 November 2025
How to implement EU-GMP Chapter 8
A revised German Cannabis Flower Monograph has been announced to be published in the German Pharmacopoeia (Deutsches Arzneibuch, DAB). The announcement by the German Federal Institute for Drugs and Medical Devices (BfArM) dated 26 April 2024 was published in the Federal Gazette ("Bundesanzeiger") on 14 May 2024.
The revison relates to the correction of the wording for the content calculation (formula) in the assay of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) resulting from the content of the corresponding acids.
The amended and revised German Pharmacopoeia will be valid from 1 October 2024. The new version is called ‘Deutsches Arzneibuch 2024 (DAB 2024)’ and can be obtained from the German publisher "Deutscher Apotheker Verlag".
The European Pharmacopoeia (Ph. Eur.) meanwhile contains an official Cannabis Flower monograph, which will be implemented on 1 July 2024. It is expected that the German Cannabis Flower monograph will be removed from the DAB once a valid official German translation of the Ph. Eur. Cannabis Flower monograph becomes available.
Related GMP News
07.10.2025Impurities and Contaminants in Food Supplements
07.10.2025Determination of Thujone
07.10.2025Microscopic Examination of Herbal Drugs
10.09.2025Final Revised GACP Guideline Published
28.08.2025Draft Public Statement on Cannabis Flos
28.08.2025Revised Ph. Eur. Cannabis Monograph