EDQM pre-publishes Ph. Eur. Cannabis Flower Monograph

Recommendation

5/6 June 2024

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

As previously announced the new Ph. Eur. monograph Cannabis flower was adopted and will be published in Ph. Eur. Supplement 11.5 in January 2024 (with an implementation date of 1 July 2024.). Due to the exceptionally high interest from stakeholders the EDQM pre-published the final text of the Ph. Eur. Cannabis flower Monograph in October 2023.

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.

Already save the date: the next GMP for Cannabis Conference will be held Live Online on 5/6 June 2024.