A new monograph of the Cannabis flower 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 of an herbal medicine. This is the first modern official monograph of Cannabis in a widely adopted pharmacopoeia.
The cannabis flower monograph is now available online and will be published in Supplement 11.5 of the European Pharmacopoeia (Ph. Eur.) in January 2024. It includes information such as the appropriate way to collect and process a sample of dried cannabis flower, and is intended for use with the General Monograph on Herbal Medicines, which also includes requirements that may be relevant.
The European Directorate for the Quality of Medicines and Healthcare (EDQM) plans to organize a webinar for its members on December 14, 2023, to present the new monograph. The implementation of the text is then planned for July 1, 2024.
The organization says the new monograph takes into account information received from several national authorities regarding the use of cannabis in their jurisdictions and includes additional limits for arsenic, cadmium and lead in cases where the medicinal plant must be prescribed to patients.
What impact for medical cannabis in Europe?
The new monograph will be important for companies that produce cannabis in Europe, with new standards to meet, and for companies that export cannabis to the European market. It will provide clearer criteria for the classification of different cannabis chemotypes and establish specific tests/requirements for identification, foreign material content, loss on drying, heavy metals and cannabinoid content.
“The importance and influence of the European Pharmacopoeia in the Canadian and global cannabis industry cannot be overstated. The inclusion of a monograph dedicated to cannabis consolidates the growing acceptance of this plant and provides necessary clarity to cannabis producers in Canada and around the world,” explains Tom Ulanowski, Chairman of the C-45 Board of Directors. Quality Association, an industry association that represents QAPs, labs and others in Canada’s cannabis industry, at StratCann.
He also adds that cannabis analysis laboratories will have to integrate these changes when they come into force next summer.
“Canadian cannabis producers generally use the American or European pharmacopoeia to release batches of cannabis flowers, both for domestic and international markets. This new monograph will require companies to update their batch release and testing criteria by July 2024. Analytical laboratories may also need to expand the scope of their testing services to ensure that they are able to meet the requirements of the new monograph. »
“The impact of this monograph is considerable. Not only will it shape the European and Canadian markets, but it is also poised to influence the trajectory of the U.S. Pharmacopoeia, which has yet to publish its own cannabis-specific monograph. »
The United States Pharmacopeia (USP) also recently proposed a new monograph for cannabis.
“As part of the safety net that protects and promotes public health in the United States, USP is taking steps to prevent harm to patients from exposure to substandard, over-potent, contaminated, or adulterated cannabis intended for medical use under state law,” the authors of the new USP monograph wrote earlier this year.