A monograph on Cannabis flower published in the European Pharmacopoeia

A new monograph on Cannabis flower was recently adopted at a session of the European Pharmacopoeia Commission 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 for Cannabis in a widely adopted pharmacopoeia.

The monograph on the cannabis flower 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 hold a webinar for its members on December 14, 2023, to present the new monograph. Implementation of the text is then scheduled for July 1, 2024.

The organization states that 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 is to be prescribed to patients.

What impact will medical cannabis have in Europe?

The new monograph will be important for companies producing cannabis in Europe, with new standards to meet, and for companies exporting cannabis to the European market. It will provide clearer criteria for the classification of different cannabis chemotypes and will establish specific tests/requirements for identification, foreign matter content, drying loss, 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 brings much-needed clarity to cannabis producers in Canada and around the world,» explains Tom Ulanowski, Chairman of the Board of the C-45 Quality Association, an industry association representing QAPs, laboratories and other players in the Canadian cannabis industry, at StratCann.

He also adds that cannabis labs will have to integrate these changes when they come into effect next summer.

«Canadian cannabis producers typically use the U.S. or European pharmacopoeia to release batches of cannabis flowers for both domestic and international markets. This new monograph will require companies to update their batch release and testing criteria by July 2024. Testing laboratories may also need to expand the scope of their testing services to ensure 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 US pharmacopoeia, which has yet to publish its own cannabis-specific monograph.»

The United States Pharmacopoeia (USP) has also recently proposed a new monograph on cannabis.

«As part of the safety net that protects and promotes public health in the United States, USP takes steps to prevent harm to patients from exposure to substandard, over-potent, contaminated or adulterated cannabis intended for medical use under state law,» wrote the authors of USP's new monograph earlier this year.