One for the books: European Pharmacopoeia establish a monograph for cannabis flower

It has been announced that the official cannabis flos (flower) monograph will be published in supplement 11.5 of the European Pharmacopoeia in January 2024. 

This will establish international quality and standards testing and identification processes for cannabis flowers, and its derived products, used in medicinal practices. 

The draft version of this monograph was published by the Council of Europe in October 2022, and they published a newsroom article seeking feedback from the public. Then in June, during the 176th session of the European Pharmacopoeia Commission, a new monograph was adopted. 

This monograph has now also been released online. In it, cannabis flos is defined as “dried, whole or fragmented, fully developed female inflorescence of Cannabis Sativa L”, and requirements to ensure cannabis remains safe, suitable, and of consistent quality, are detailed. 

Although the official monograph is yet to be published, this pre-release does offer a lot of insight into how medical cannabis will be identified, categorised, and standardised within Europe in the near future.

So, what is the European Pharmacopoeia?

The European Pharmacopoeia serves as a single reference for official European standards and requirements that have been created to ensure the safety, efficacy, and standard of a specific medicinal product or substance. 

Pharmacopoeias are published as a set of guidelines to ensure these standards are upheld. The European Pharmacopoeia is recognised now by 39 countries across Europe, including the UK, to ensure continuity in medicinal products exists at an international scale. 

Prior to World War 2, nations typically released their own Pharmacopoeias to establish rules and guidelines for their own healthcare providers and medicine manufacturers. However, since 1964, The Council of Europe have adopted an international approach, and now each member state is welcomed to contribute evidence and opinion when monographs are created.

And, what is a monograph?

Monographs are established by official sources and organisations, such as The European Directorate for the Quality of Medicines and Healthcare (EDQM), to describe the legally binding quality standards for a substance. 

Monographs define the substance and the context in which they are used. They contain detailed information about the analytical processes used to identify it, determine its strength and concentration, and put controls in place to ensure the quality remains high, and the quantitative strength remains stable and consistent, from batch to batch. 

These texts also contain information about how contaminants or impurities within substances can be found, and details how these processes work. Limits for impurities and contaminants are stated in official monographs to make sure these medicines remain safe, and do not contain ingredients that are potentially toxic, or are not of therapeutic benefit to the patient. 

Pre-release of the cannabis flower monograph

The Pre-release of the Cannabis Flos Monograph contains a broad set of requirements that flowers will have to meet in order to be prescribed as a medicinal product. This monograph explains identification processes, microscopic examinations, and analysis methods, that should be used to give an accurate representation of cannabinoid concentrations, and impurity presence within cannabis flowers. 

High-performance thin-layer chromatography and Liquid chromatography are endorsed as the ideal methods of analysis to test cannabinoid concentrations, and standardised equations are given for use during this process. 

The monograph states: “if the herbal drug is to be prescribed to patients as a medicinal product, the measured contents of total tetrahydrocannabinol and total cannabidiol, respectively, do not deviate from the values stated on the label by more than ± 10 per cent.”

And, the guidance provided for labelling is as follows: 

Product Type	THC limit	CBD limit
THC-dominant type	“Total tetrahydrocannabinol, expressed as Δ9 -tetrahydrocannabinol (C21H30O2 ; Mr 314.5): minimum 5.0 per cent (dried drug).”	“Total cannabidiol, expressed as cannabidiol (C21H30O2 ; Mr 314.5): maximum 1.0 per cent (dried drug).”
CBD-dominant type	“Total tetrahydrocannabinol, expressed as Δ9 -tetrahydrocannabinol (C21H30O2 ; Mr 314.5): maximum 1.0 per cent (dried drug).”	“Total cannabidiol, expressed as cannabidiol (C21H30O2 ; Mr 314.5): minimum 5.0 per cent (dried drug).”
THC/CBD-intermediate type  total tetrahydrocannabinol / total cannabidiol ratio: 0.2 to 5.0 (dried drug).	“Total tetrahydrocannabinol, expressed as Δ9 -tetrahydrocannabinol (C21H30O2 ; Mr 314.5): minimum 1.0 per cent (dried drug).”	“Total cannabidiol, expressed as cannabidiol (C21H30O2 ; Mr 314.5): minimum 1.0 per cent (dried drug).”

As well as establishing specific quantities that qualify cannabinoid concentrations, the monograph details limits for contaminants, foreign matter, and impurities to ensure that medical cannabis is as safe as possible. 

When enacted, no more than 0.1 parts per million (ppm) of mercury, 0.2ppm of arsenic, 0.3ppm of cadmium, and 0.5ppm of lead, will be permitted in cannabis if it is prescribed to patients as a medicinal product in Europe. 

What makes this monograph so important?

The introduction of the cannabis flos monograph in the European Pharmacopoeia has been well awaited by many in the industry, and marks a pivotal moment in the regulation and standardisation of medical cannabis across Europe. 

With the establishment of standardised testing and identification processes, this monograph guarantees that medical cannabis and its derived products meet strict quality and safety standards. This is crucial for patients who rely on these products for their wellbeing, as they can trust that what they will be receiving is consistent and reliable.

In addition to this, by detailing these requirements and guidelines, producers will be held to a higher level of accountability. This will help to eliminate potential risks associated with substandard products, and provide transparency for patients. 

By setting these stringent limits for contaminants and impurities, and establishing these measures to qualify cannabis products, it can be seen that international bodies are prioritising patient safety, and helping to establish a more regulated industry. 

In conclusion, the publishing of the final Cannabis Flos Monograph will be a significant step forward in cementing, and securing, the medical cannabis industry and product standardisation across Europe. 

By providing these clear guidelines, structures, and standards, patients will not only benefit from consistent and high quality cannabis, but cooperation and accountability in the field of medical cannabis will benefit the industry in turn. 

This milestone is a testament to the evolving acceptance of cannabis-based treatments, and shows how healthcare regulations are changing across Europe to embrace these options, with a focus on improving patient outcomes and ensuring their wellbeing. 

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