The European Pharmacopoeia (Ph. Eur.) Commission has pre-published the upcoming cannabis flower monograph (3028) on the EDQM (European Directorate for the Quality of Medicines & Healthcare) website, which has attracted the attention of stakeholders in the medical cannabis industry. This early look provides an interesting preview of what medical cannabis companies may expect.
EDQM: comprehensive cannabis monograph
On June 20 and 21, 2023, the European Pharmacopoeia Commission officially approved the Cannabis flower monograph, which is set to play a key role in the regulation of cannabis-based medicines. The Ph. Eur. Commission decided to make it immediately accessible on the EDQM website for informational reasons due to the extraordinary interest and enthusiasm from stakeholders excited to see this highly anticipated document. This monograph will be officially available in Ph. Eur. Supplement 11.5, which will be available in January 2024 and go into effect in July 2024.
The EDQM has scheduled a webinar for December 14, 2023. Its aim is to help stakeholders understand the complexities of the new monograph and get ready for its implementation. This educational session will explain in detail cannabis flower monograph will. It must guarantee that all stakeholders are ready for the text’s enforcement, which starts on July 1, 2024.
Understanding the cannabis flower monograph
The concept of the herbal drug as the dried, whole or fragmented, fully grown female inflorescences of Cannabis sativa L. is explored in the Cannabis flower monograph. It is crucial to note that this document comes in conjunction with the general monograph on herbal medications (1433). This one describes additional requirements that are pertinent unless otherwise indicated within the Cannabis flower monograph.
There is one thing which distinguishes this monograph from others. It is the inclusion of data acquired from several national authorities. The details focus on the use of the herbal drug within their respective jurisdictions.
The cannabis flower can be a starting point for the creation of extracts or recommended unmodified for patient use. They can be applicable either for oral or inhalation delivery. The monograph provides precise requirements. It includes content restrictions, production standards, and testing for foreign matter, arsenic, cadmium, and lead in situations where the herbal medication is meant for patient intake.
Key practical information
The explanation of the application of cannabis flower for system suitability in High-Performance Liquid Chromatography (HPLC) Reference Standard (HRS) and cannabidiol for cannabis Certified Reference Standard (CRS) is a remarkable feature of the monograph. It’s vital to note that neither of these requirements is currently specified in the Ph. Eur. catalogue. However, as soon as they are accessible, the EDQM will post a notice on their website.
The monograph provides important, useful information while highlighting the significance of appropriate sample preparation. It suggests milling, grinding, or cutting samples in accordance with appropriate procedures to reduce the chance of herbal drugs degrading as a result of the heat produced during these processes. The sticky nature of the trichomes on the surface of the Cannabis sativa L. flower creates particular problems. Therefore, it is essential to provide a consistent particle size, a representative content, and a homogeneous distribution of trichome-components in the sample.
Important is also a focus on cutting techniques. Cutting specifications are added in situations where patients’ prescriptions are required. The monography says:
“If the herbal drug is to be prescribed to patients as a medicinal product, the inflorescence is cut at the base with minimal rachis remaining.”
Additional details say that if the herbal drug is to be prescribed to patients as a medicinal product, it should not contain any seeds. What is more, the whole herbal drug must not contain any leaves longer than 1 cm. The label must state the percentage contents of total tetrahydrocannabinol and total cannabidiol. In addition, the label must show if the herbal drug is to be prescribed to patients as a medicinal product.
Medical cannabis industry and EDQM
Last but not least, the pre-publication of the Cannabis flower monograph on the EDQM website represents a significant advancement in the regulation and standardisation of medical cannabis in Europe. This paper promises to improve the efficacy and security of herbal medications made from Cannabis sativa L. The upcoming webinar and ongoing updates from the EDQM will be crucial. They will ensure an easy transition for all stakeholders as we get closer to the enforcement date of July 1, 2024.