Can Cannabis Flowers be pre-dried in Accordance with GACP?

After Swissmedic had already published a leaflet, the Hessian State Office for Health and Care (Hessisches Landesamts für Gesundheit und Pflege - HLfGP) published a leaflet on the production of medicinal cannabis flowers in July.

Can pre-drying be carried out in accordance with GACP?

No - this is the position taken in Hesse. Timely GMP-compliant processing of the cannabis flowers, including drying and trimming, at the place where the plants are harvested is considered necessary "unless it can be demonstrated beyond any doubt that quality losses resulting from the absence or incomplete drying by the grower can be ruled out"*. In addition, the Qualified Person (QP) who releases the cannabis flowers for placing on the market in accordance with Section 19 of the German Medicinal Products Act (Arzneimittelgesetz, AMG) is responsible for the GMP-compliant processing of all intermediate stages. This "responsibility remains in place even if individual manufacturing steps are carried out at other sites in other EU Member States or in third countries and, under the applicable local legislation, the EU GMP Guide does not apply to the manufacture of cannabis flowers".

The document "GMP Requirements for Cannabis 2026" can be found on the HLfGP website under "Arzneimittel & Apotheken - Herstellung", in the Downloads section.

* Translation by Ed. Team