Posted on Jul 31, 2023

The European Pharmacopoeia Commission (EPC) has adopted a new European monograph for Cannabis flower

The European Pharmacopoeia Commission has adopted a new European monograph for Cannabis flower at the latest Commission meeting in June 2023. The monograph describes quality requirements for the raw material Cannabis flower.

The monograph Cannabis flower (Cannabis flower, monograph 3028) will be implemented in Ph. Eur. on 1 July 2024 with supplement volume 11.5. It will be published and available to Ph. Eur. licence users in January 2024.

Consequence for the monograph in DLS

When the European monograph for Cannabis flower comes into force in Ph. 1 July 2024, the European monograph will be implemented and applicable in Denmark upon publication of DLS 2023.5 (1 July 2024). The Danish monograph for Cannabis flower will thus become invalid and removed from the Danish Drug Standards Order from 1 July 2024 (DLS is available at www.retsinformation.dk).

An important step for the cannabis industry in Europe and the path towards EU harmonisation in the field

The European monograph for Cannabis flower will be available in Ph. 1st of July 2024.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. Moreover, they had necessity to establish exact requirements for the composition, purity, and identification of cannabis flower and CBD. The monograph offer a scientific standard to follow, assisting in the harmonisation of cannabis-related laws throughout Europe.

How to stay updated in the future

On the Pharmeuropa website, it is possible to sign up for notifications so that you will automatically be notified if there are new updates to the European monograph for Cannabis flower.