05 Apr NEWS from Germany – Medical use of cannabis: BfArM (Federal Institute for Drugs and Medical Devices) establishes cannabis agency for future cannabis cultivation in Germany
With the upcoming entry into force of the “Cannabis as Medicine” law, a cannabis agency has been established at the BfArM. The cannabis agency will control and regulate the cultivation of cannabis for medical purposes in Germany. Immediately after its establishment, the cannabis agency will start an EU-wide tendering procedure and subsequently award contracts for cultivation to suitable companies. The aim is to ensure the supply of critically ill patients with pharmaceutical-grade cannabis grown in Germany.
The cannabis agency will be introduced as a new department in Division 4 “Complementary and Traditional Medicinal Products”.
The BfArM assumes that cultivated cannabis will be available in Germany in 2019. The import of cannabis will also be possible beyond this time. Currently, cannabis is imported from the Netherlands and Canada for medical purposes. Basically, cannabis can be imported from any country that can carry out the cultivation of cannabis for medical purposes under state control and can offer cannabis of pharmaceutical-grade quality.
Cannabis will be grown exclusively for medical purposes. It is a medicine; and the products must therefore meet the relevant requirements of the Drug and Narcotics Law. In order to ensure the necessary pharmaceutical quality, cultivation is subject to the “Good Practice and Collection Practice” (GACP) and relevant monographs and guidelines.
For more information and to access the press release (in German), you can visit the BfArM link here or contact our DE member for more information.