5/6 October 2023
The German Federal Ministry of Health (Bundesministerium für Gesundheit - BMG) has presented the draft bill of the Law on the Controlled Use of Cannabis (Cannabisgesetz - CanG) - including the explanatory memorandum.
The draft bill provides for two new laws - the law on private and communal non-commercial self-cultivation of cannabis for non-medical purposes (Cannabisanbaugesetz - CanAnbauG) and the law on the supply of medical cannabis (Medizinal-Cannabisgesetz - MedCanG). The draft bill for Pillar 1 (Pillar 2 = regional model projects) also provides for the deletion of cannabis (and THC / dronabinol) from the Narcotics Act (BtMG) with the legalisation of cannabis. Among other things, it will then be possible to prescribe medical cannabis on a normal prescription (medical cannabis may only be dispensed for patients by pharmacies). In addition, proof of security is no longer mandatory for the BfArM approval (see below). In future, proof of sufficient security against unauthorised withdrawal will no longer be required, as this is usually ensured by other regulations (e.g. in the German Arzneimittelgesetz - AMG). If, in individual cases, a safeguard is not sufficient, the BfArM has the option of issuing a separate safeguard order.
Anyone who produces medicinal cannabis as a medicinal product (in accordance with the German Medicines Act (AMG) and thus GMP-compliant) needs a manufacturing authorisation and a Qualified Person (QP). In addition, a license under the narcotics law (for handling the narcotic cannabis) by the German Federal Opium Agency was required up to now. This is now to be replaced by a license according to the MedCanG, for which a responsible person according to the MedCanG must be appointed to ensure compliance with these regulations.
Among other things, the following applies:
The licensing procedure according to MedCanG also provides, among other things, for obligations to keep records, to submit reports and for monitoring measures that largely correspond to those of the BtMG.
For more information, see the draft bill on the Cannabis Act (CanG) on the BMG website (in German).