Since March of 2017, people with severe illnesses can get a prescription from their doctor for medical cannabis from the pharmacy. Growing cannabis yourself is still prohibited. Cannabis grown in Germany for medical use is not expected to be available until the end of 2020 either. Until then, the need to import cannabis for medical use from neighbouring countries and non-EU states will continue.
Nevertheless, the stipulation that medicinal plants that are cultivated or collected have to meet established quality requirements applies here as well. Thus there is no doubt that the recognised GACP (Good Agricultural and Collection Practice) rules apply, with good cause. In the course of further processing however, not only a GMP-compliant approach has to be considered but also to what extent GACP and GMP differ from each other.
“Now that the cultivation of medical cannabis in Germany has been given the green light, there is not just the question of differentiation between GACP and GMP, but also the matter of a GMP-compliant bunker,” says Alexander Trautmann, Pharmacist and Principal Consultant at gempex. “Based on rising demand, it can be assumed that medical cannabis will continue to be imported in the future. This is due to the purchase quantity limit totalling 10.4 tons of cannabis, which has been established for the next four years by the Cannabis Agency of the Federal Institute for Drugs and Medical Devices (BfArM).”
In his lecture “Medical cannabis – a GMP challenge” at LOUNGES, Alexander Trautmann illuminates precisely these issues and also reports on the GMP challenges in practice.
Medical cannabis – a GMP challenge
Alexander Trautmann, gempex GmbH
29 January 2019 | 4:30 pm | Room 9
dm-Arena, trade fair Karlsruhe
Get your free ticket!
Registration code: SA0PZZFZ (gempex exhibition booth D1.2)