In June, the first monograph on cannabis flower was published following a meeting of the European Pharmacopoeia Commission. Such monographs serve as a guide to the basic specifications of plant drugs. This is the first modern official monograph on hemp in a widely accepted pharmacopeia.
The hemp flower monograph is now available online and will be published in Appendix 11.5 of the European Pharmacopoeia (Ph. Eur.) in January 2024. It contains information on how to properly collect and process samples of dried hemp flowers. It is intended for use with the General Monograph on Plant Medicines, which contains additional requirements.
The European Directorate for Quality of Medicines and Healthcare (EDQM) plans to hold a webinar for its members on December 14th, 2023, to present the new monograph. Implementation of the text is scheduled for July 1st, 2024.
Read more on the subject and find the latest hemp news of the day with the Hemp.im mobile app.
The monograph’s impact on the medical cannabis market
The new monograph takes into account information received from several national authorities regarding the use of cannabis in their jurisdictions. It sets additional limits for arsenic, cadmium, and lead in cases where the medicinal plant must be prescribed to patients.
The monograph will be crucial for companies producing cannabis in Europe and exporting to the European market. It will establish clear criteria for classifying different cannabis chemotypes and set specific tests/requirements for identification, foreign material content, drying loss, heavy metals, and cannabinoid content.
Expert opinion about the new monograph
Tom Ulanowski, chairman of the Board of Directors of the C-45 Quality Association, which represents laboratories and others in the Canadian cannabis industry, at StratCann, said: “The importance and impact of the European Pharmacopoeia on the Canadian and global hemp industry is enormous. The inclusion of a monograph on hemp confirms the growing acceptance of the plant and provides needed clarity for hemp producers in Canada and around the world.”
He added that laboratories analyzing hemp will have to take these changes into account when they take effect next year.
Ulanowski added, “Canadian cannabis producers typically use the U.S. or European pharmacopeia to release batches of cannabis flower, both domestically and internationally. This new monograph will force companies to update their batch release and testing criteria by July 2024. Analytical laboratories may also need to expand 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 yet to publish its own monograph on hemp.”
The hemp monograph in the U.S. pharmacopoeia
The United States Pharmacopeia (USP) also recently proposed a new monograph on hemp. The authors of the new USP monograph previously wrote: “As part of a safety system that protects public health in the United States, USP takes steps to protect patients from exposure to substandard, over-potent, contaminated or counterfeit cannabis for medical use in accordance with state law.”
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First published in Fakty Konopne. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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