Omission of the German Cannabis Monograph
Recommendation
6/7 May 2025
Challenges and Solutions for Packaging / Devices & Single Use Systems
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An announcement by the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has been published in the German Federal Gazette (Bundesanzeiger) on 11 March 2025. The publication contains the revised German Pharmacopoeia (Deutsches Arzneibuch, DAB) texts and monographs adopted by the DAB Commission in October 2024.
Due to the availability of the Ph. Eur. Cannabis Flower monograph - which was implemented with Suppl. 11.5 in July last year - the current version of the German Pharmacopoeia (Deutsches Arzneibuch, DAB) is amended as follows:
The DAB monograph Cannabis flower (Cannabis flos - Cannabisblüten) is deleted.
The amended and revised German Pharmacopoeia will apply from 1 July 2025. The new version is entitled "Deutsches Arzneibuch 2025 (DAB 2025)" and can be obtained from the German publisher "Deutscher Apotheker Verlag". For medicinal products that are on the market on 1 July 2025 and do not meet the requirements of the DAB 2025 or have not been manufactured, tested or labelled in accordance with its provisions, but comply with the provisions in force on 30 June 2025, this announcement will only apply from 1 January 2026.
More information is available in the German Bundesanzeiger (Federal Gazette).
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