By / October 24, 2023

New Cannabis Monograph in the European Pharmacopoeia: What Does It Mean for the Industry?

In June, following a meeting of the European Pharmacopoeia Commission, the first monograph of the cannabis flower was published. Such monographs serve as guidelines concerning the basic specifications of herbal medicines. This is the first contemporary official cannabis monograph in a widely accepted pharmacopoeia.

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Monograph Availability and Publication

The monograph concerning the cannabis flower is already available online and will be published in supplement 11.5 of the European Pharmacopoeia (Ph. Eur.) in January 2024. It contains information on the proper collection and processing of dried cannabis flower samples. It is intended to be used with the General Monograph on Herbal Medicines, which contains additional requirements.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) plans to organize a webinar for its members on December 14, 2023, to introduce the new monograph. The implementation of the text is scheduled for July 1, 2024.

Impact on the Medical Cannabis Market

The new monograph takes into account information received from several national bodies concerning the use of cannabis in their jurisdictions. It establishes additional limits for arsenic, cadmium, and lead in cases where the medicinal plant must be prescribed to patients.

Industry Significance of Monograph

The monograph will be crucial for companies producing cannabis in Europe and exporting to the European market. It will establish clear criteria for the classification of different chemotypes of cannabis and will define specific tests/requirements concerning identification, foreign matter content, loss on drying, heavy metals, and cannabinoid content.

Expert Opinion

Tom Ulanowski, chairman of the Board of Directors of the C-45 Quality Association, which represents laboratories and other entities in the Canadian cannabis industry, in StratCann, said: “The significance and impact of the European Pharmacopoeia on the Canadian and global cannabis industry are enormous. The inclusion of a monograph dedicated to cannabis confirms the growing acceptance of this plant and provides needed clarity to cannabis producers in Canada and around the world.”

He also added that laboratories analyzing cannabis will have to consider these changes when they take effect next year.

Ulanowski added, “Canadian cannabis producers usually use the American or European pharmacopoeia for releasing batches of cannabis flowers, both for domestic and international markets. This new monograph will force 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 meet the requirements of the new monograph.

“The impact of this monograph is significant. It shapes the European and Canadian markets, but it also has the potential to influence the trajectory of the United States Pharmacopeia, which has not yet published its own cannabis-specific monograph.”

Monograph of Cannabis in the United States Pharmacopoeia

The United States Pharmacopeia (USP) has also recently proposed a new cannabis monograph. The authors of the new USP monograph previously wrote: “As part of the safety system protecting public health in the United States, the USP is taking steps to protect patients from exposure to substandard, overly potent, contaminated, or counterfeit cannabis intended for medical use according to state law.”

(Featured image by CRYSTALWEED Cannabis via Unsplash)

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