A new cannabis flower monograph was recently adopted at a session of the European Pharmacopoeia Commission held in June.
A monograph of this type is used to provide guidance on the basic specifications for an herbal drug. This is the first modern official cannabis monograph in a widely adopted pharmacopoeia.
The monograph on cannabis flower is now available online and will be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.5 in January 2024. It includes information such as how to appropriately collect and process a sample of dried cannabis flower, and is intended to be used along with the general monograph on Herbal drugs, which also includes requirements that may be relevant.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) expects to hold a webinar for its members on December 14, 2023, to present the new monograph. The implementation of the text is then expected by July 1, 2024.
Editor’s Note: Update from May 2024. Information on the status of cannabis dry extract, cannabis liquid extract, and cannabis soft extract, are available here.
The organization says the new monograph takes into account information it received from several national authorities concerning the use of cannabis in their jurisdictions and includes additional limits for arsenic, cadmium, and lead for cases in which the herbal drug is to be prescribed to patients.
Andrew Waye, the acting manager of Health Canada’s Risk, Research, and Advice Division of the Office of Cannabis Science and Surveillance, said in a recent post on X that he was honoured to work with experts in Europe on the monograph.
“I look forward to continued involvement with the cannabis QC efforts of both the Ph Eur & USP, and to keep learning from the other experts that have been assembled to contribute to this important work,” wrote Waye.
Hubert Marceau, the director of development at Laboratoire PhytoChemia in Quebec, which conducts analytical testing for cannabis companies, says the new monograph will be important for Canadian companies exporting cannabis into the European market.
“It won’t have a legal impact in Canada, but for export to Europe, it’s very important. The importer will ask for the monograph. The information found in a monograph like this is the basis on which all regulations are based. It’s a list of tests that need to be done on the product and the acceptable limits that need to be applied.”
Marceau says he and most other analytical chemists have been aware these changes were coming, but one change in the most recent publication that caught him by surprise was the distinction between limits for cannabis for medical purposes compared to non-medical purposes.
“It’s an important distinction because most cannabis in Canada is not for medical purposes. So if Canada would apply this monograph to cannabis here, then the cannabis which would be sold through a provincial dealer wouldn’t have any limits on variation. But cannabis sold as a medicinal product would have variation limits.”
He says similar standards for non-medical cannabis could potentially address the ongoing issue of THC inflation.
“The impact of this monograph is far-reaching. Not only will it shape European and Canadian markets, but it’s also poised to influence the trajectory of the US Pharmacopeia, which has yet to publish its own cannabis-specific monograph.”
Tom Ulanowski, C-45 Quality Association
Tom Ulanowski, Board Chair for the C-45 Quality Association, an industry association that represents QAPs, Labs, and others in the industry, agrees about the importance of this new monograph, saying it will provide clearer criteria for the classification of different cannabis chemotypes, and establish specific tests/requirements for identification, foreign matter content, loss on drying, heavy metals, and cannabinoid content.
“The European Pharmacopoeia’s prominence and influence in the Canadian and global cannabis industry cannot be overstated. Their inclusion of a dedicated monograph for Cannabis solidifies the plant’s growing acceptance and provides much needed clarity for cannabis producers in Canada and around the world.”
He also adds that cannabis testing labs will need to understand these changes by the time they come into effect next summer.
“Canadian cannabis producers typically utilize either the US or European Pharmacopeia for releasing batches of cannabis flower, for both domestic and international markets. This new monograph will require companies to update their batch release and testing criteria by July 2024. Analytical testing laboratories may also need to expand their scope of testing services to ensure they are able to meet the requirements of the new monograph.
“The impact of this monograph is far-reaching. Not only will it shape European and Canadian markets, but it’s also poised to influence the trajectory of the US Pharmacopeia, which has yet to publish its own cannabis-specific monograph.”
The US Pharmacopeia (USP) also recently proposed a new cannabis monograph.
“As part of the safety net that protects and promotes public health in the US, USP is taking steps to prevent harm to patients resulting from exposure to substandard, super-potent, contaminated or adulterated cannabis for medical use under state law,” wrote the authors of the new USP monograph earlier this year.
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