Ph. Eur. Monographs for Cannabis Flower and CBD adopted

The EDQM recently announced that the final Ph. Eur. Monographs for Cannabis flower and Cannabidiol (CBD), isolated from the Cannabis sativa L. plant, will be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.5 (January 2024), with an implementation date of 1 July 2024.

Will it be a step forward to EU harmonization of Quality Requirements?

It is expected that the Ph. Eur. Monograph for Cannabis Flower will replace the national EU monographs. However, the final versions of the two monographs are not publicly available yet. Only the draft versions of the Ph. Eur. monographs Cannabis flower and Cannabidiol have been published so far, and it is expected that due to the comments received, adaptations to the final versions have been made. Thus, we currently do not know about the differences between the national Cannabis Flower monographs (like DAB, Ph. Helv., etc.) and the final Ph. Eur. monograph. E.g. regarding CBD it is now stated in the EDQM announcement that CBD is isolated from the Cannabis sativa L. plant, In the draft it was stated that CBD is isolated from natural sources. In addition, the German DAB Monograph tests on Identity via TLC, whereas the draft Ph. Eur. Cannabis flos monograph proposed HPTLC and also proposed specific acceptance limits for the three chemotypes. Moreover, there was a significant difference for the proposed heavy metal limits. Thus, we will have to wait for the final Ph. Eur. monographs to be available to see what the differences will be in detail - and what level of harmonization has been achieved.

More information is available in the EDQM Newsroom under Outcome of the 176th session of the European Pharmacopoeia Commission, June 2023.