Qualification of medical-grade cannabis

In Europe, medical cannabis products must comply with the relevant requirements laid down in the Medicinal Law (including Pharmacopoeias, EU-GMP/GDP and GACP) and the Narcotics Law. In Germany, for example, the BfArM (the Federal Institute for Drugs and Medical Devices) has taken over new responsibilities by establishing the Cannabis Agency. The goal of the agency is to contribute to ensuring the supply of medical-quality cannabis.

Cannabis is not meant to be stored directly at BfArM during any stage of the purchasing, harvesting or distribution process. These steps will be carried out by relevant producers or other commissioned companies (i.e. suppliers, importers). Hence, the agency will only manage and monitor the cultivation, harvest, processing, quality assurance, storage, packaging and distribution of cannabis to wholesalers, chemists or manufacturers.

The EU-GMP inspectorates are responsible for issuing manufacturing and import licences or EU-GMP Certificates. Thus, they will perform inspections at production sites of manufacturers who apply for these certificates and licences. For example, the starting point for any German GMP certification is a German-based company that applies for such a certificate at their responsible local authority.