The new monograph on Cannabis flower (3028) was adopted at the 176th session of the European Pharmacopoeia (Ph. Eur.) Commission held on 20 and 21 June 2023. Given the exceptionally high interest from stakeholders in having access to the new text as soon as possible, the Ph. Eur. decided to make the monograph immediately available on the EDQM website for information. The monograph will be published in Ph. Eur. Supplement 11.5 in January 2024.
For unpublished figures and other practical information typically included in the Knowledge database, please scan the QR code given in the monograph or visit https://kd.edqm.eu/KD3028.
The new text covers the herbal drug defined as the dried, whole or fragmented, fully developed female inflorescences of Cannabis sativa L. It is 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 monograph.
The new monograph takes into account information received from a number of national authorities concerning the use of the herbal drug in their jurisdictions: it can be employed as a raw material for the production of extracts or it can be prescribed as is, to be taken by patients by inhalation or oral administration. Additional requirements have been included in the limits for content, in the production section and in the tests for foreign matter, arsenic, cadmium and lead for cases in which the herbal drug is to be prescribed to patients.
Please note that the monograph describes the use of cannabis flower for system suitability HRS and cannabidiol for cannabis CRS, neither of which is currently listed in the Ph. Eur. catalogue. An announcement will be made on the EDQM website when they become available.
Cannabis Flower Quality Requirements
The new text covers the herbal drug defined as the dried, whole or fragmented, fully developed female inflorescences of Cannabis sativa L. It is to be read in conjunction with the general Ph. Eur. monograph Herbal drugs, which includes additional requirements (e.g. pesticides, microbial contamination) that are applicable unless otherwise stated in the Cannabis flower monograph.
The new monograph takes into account information received from a number of national authorities concerning the use of the herbal drug in their jurisdictions:
- as a raw material for the production of extracts
- it can be prescribed as is, to be taken by patients by inhalation or oral administration.
Additional requirements have been included in the limits for content, in the production section and in the tests for foreign matter, arsenic, cadmium and lead for cases in which the herbal drug is to be prescribed to patients as a medicinal product.
Moreover the monograph describes the use of cannabis flower for system suitability HRS (herbal reference standard) and cannabidiol for cannabis CRS (chemical reference substance). However, neither of which is currently listed in the Ph. Eur. reference standards catalogue. An announcement will be made on the EDQM website when these reference standards become available.
More information is available in the EDQM Newsroom under Ph. Eur. pre-publishes Cannabis flower monograph on the EDQM website.