Update on the German CBD Monograph
Recommendation

1/2 December 2026
How to implement EU-GMP Chapter 8
The cannabidiol monograph has now been published and implemented in the European Pharmacopoeia (Ph. Eur.). In such cases, the monograph of the same name in the German Drug Codex (Deutscher Arzneimittel-Codex - DAC) is usually withdrawn to avoid duplication of content. However, according to the Ph. Eur. monograph, only cannabidiol (CBD) derived from the plant is compliant to the monograph. Synthetic CBD does (currently) not comply with the Ph. Eur. monograph, as it defines the substance as "isolated from the Cannabis sativa L. plant.". Therefore, the DAC CBD monograph continues to exist – but under the new name "C-052 Synthetic Cannabidiol". The present DAC specification applies exclusively to the synthetically produced substance.
More information can be found in the German Drug Codex/New Prescription Formulary (Deutscher Arzneimittel-Codex/Neues Rezeptur Formularium - DAC-NRF) (registration required).
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