Denmark clarifies Status of the Ph. Eur. Cannabis Monograph

Recommendation

10/11 October 2023

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The EDQM previously announced that the final Ph. Eur. Monographs for Cannabis flower and Cannabidiol (CBD) will be issued in the European Pharmacopoeia (Ph. Eur.) Supplement 11.5, with an implementation date of 1 July 2024. It will be published and available to licensed users of the Ph. Eur. in January 2024.

Implications for the Danish Cannabis Monograph

The Danish Medicines Agency now clarified the following: 

• The European Pharmacopoeia Commission has adopted a new European monograph for Cannabis Flower at the latest Commission meeting in June 2023. The monograph describes quality requirements for the raw material Cannabis flower.
• When the European monograph for Cannabis Flower enters into force in Ph. Eur. on July 1, 2024, the European monograph will be implemented and valid in Denmark by publishing DLS 2023.5 (July 1, 2024). The Danish monograph for Cannabis Flower will thus become invalid and removed from the Executive Order on Danish Drug Standards from 1 July 2024.

More information is available at the DMA's website.