24 July 2023

New Ph.Eur. Monographs for Cannabis flower and Cannabidiol adopted by the EDQM

The EDQM recently announced that the final Ph. Eur. monographs for Cannabis flower (3028) and Cannabidiol (CBD, 3151), 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. Supplement will also include 9 additional new monographs and three new general chapters.


The final versions of the two monographs are not yet publicly available. However, it is expected, that the Ph.Eur. monographs will replace current national monographs and harmonise quality requirements. Draft versions of the Ph.Eur. monographs Cannabis flower and Cannabidiol were published for public consultation from October until the end of December 2022. The draft text for Cannabis flower covers the herbal drug defined as dried, whole or fragmented, fully developed shoot apices of female cultivars of Cannabis sativa L. plant. Draft was to be read in conjunction with the general monograph Herbal drugs (1433), which includes additional requirements that are applicable unless otherwise stated in the Cannabis flower draft.


Based on the comments received from a number of national authorities, adaptations to the final versions have been made. We do not yet know the differences between national Cannabis Flower monographs (like DAB, Ph.Helv., etc.) and the final version of Ph.Eur. monograph. The differences between national CBD monographs (e.g. DAB) and the final version of Ph.Eur. monograph are also currently not known in detail, but some are most likely regarding tests on identity (DAB monograph: TLC, draft version Ph.Eur: HPTLC),  proposed specific acceptance limit for the three chemotypes and proposed heavy metal limits.


For more information we will have to wait for the final versions of the monographs to be published when Supplement 11.5 will be available.