New European monograph for Cannabis flower adopted

The Danish Medicines Agency (Lægemiddelstyrelsen) has announced the European Pharmacopoeia Commission has adopted a new European monograph, which describes quality requirements for the raw material Cannabis flower.

EPC’s new Cannabis flower monograph

The new monograph Cannabis flower (Cannabis flower, monograph 3028) will be available next year in January 2024 with publication of the supplement 11.5. The monograph will enter into force several months later, in July 2024.

When the European monograph for Cannabis flower is officially released in Ph. Eur., it will be implemented and applicable in Denmark upon publication of DLS 2023.5 (1 July 2024).

The Danish monograph for Cannabis flower will consequently be invalidated and removed from the Decree on Danish Pharmaceutical Standards from 1 July 2024.

According to a recent statement by Valcon Medical, a European contract manufacturing organisation (CMO) specialising in the manufacturing of medical cannabis extracts, “the addition of these cannabis monographs shows EPC’s dedication to maintaining the highest standards of quality and safety in the pharmaceutical business making sure that patients and medical professionals can rely on consistent and standardised goods.”

The CMO also acknowledged that EPC established the exact requirements for the composition, purity, and identification of cannabis flower and CBD. This monograph offers “a scientific standard to follow, assisting in the harmonisation of cannabis-related laws throughout Europe.”

Implementing quality standards for medicinal cannabis

Mikael Sodergren of Curaleaf International explained in an article published on EPR’s website last month: “there is a vast range of flavonoids, terpenoids, phytols and other compounds present at lower concentrations within the cannabis flower”. Sodergren referenced this due to there being “notable complexities to researching medical cannabis using a linear approach to clinical translation.”

To support research of this product, Sodergren added that “the European medical cannabis ecosystem is well equipped [to]… foster collaborations” to make up for the lack of resources when compared to traditional pharmaceutical companies.