Medicinal cannabis grown in Germany – quality standards and stability

The German Cannabis Agency at the Federal Institute for Drugs and Medical Devices (BfArM) was established in 2017 with the tasks of the control and management of the cultivation and production of cannabis for medical purposes in Germany. Thus, the Cannabis Agency is the distributor of cannabis flowers as medicinal products and legally acts as a pharmaceutical company and wholesaler.

The production sites of three contract partners must comply with the legal standards for narcotic, medicinal products and in particular GACP and GMP.

Medicinal cannabis must meet the requirements of the Monograph “Cannabis flowers” of the German Pharmacopoeia (DAB) and the requirements of the European Pharmacopoeia (Ph. Eur.) and as well follow all guidelines adressing the quality of herbal medicinal products. An important objective is to provide patients medicinal cannabis with a high level reproducible pharmaceutical quality.

Since its release in the market of the German Medicinal Cannabis in July 2021, only a few complaints on pharmaceutical quality have been reported and evaluated. In one case, an open package of Medicinal cannabis was reported. However, THC-content was still within the specified range after a period of seven months. In-use-stability could be demonstrated under conditions corresponding to the use in practice. In July 2021, the basic stability of medicinal cannabis cultivated and produced in Germany was set to 8 months. Now, ongoing stability studies and additional data indicate that there is an option to increase the stability to 12 months.

 

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Publication History

Article published online:
16 November 2023