The Act on the Amendment of Drugs and Other Provisions, which entered into force on 10 March 2017, has expanded the scope for the prescription of cannabis medicines. The Act provides for the establishment of a government agency, the so-called cannabis agency, in accordance with the provisions of the United Nations Unity Treaty of 1961 on United Nations drugs. This will control and control the cultivation of cannabis for medical purposes in Germany.
Until cannabis is available for medical purposes from German cultivation, the demand is still covered by imports, for which the cannabis agency is not responsible (further information – see Bundesopiumstelle ).
The Cannabis Agency is a specialist area in the Department of Admission 4 (Special Therapies and Traditional Medicines) in the BfArM . It controls cultivation, harvesting, processing, quality testing, storage, packaging as well as delivery to wholesalers and pharmacists or manufacturers. The cannabis agency will take possession of the cannabis for medical purposes after the harvest.
The harvest is not transported to the BfArM , it is not stored there, nor is it redistributed from there. These steps will be located spatially at the respective construction companies or other commissioned companies.
The cultivation is therefore not carried out in the BfArM or by the BfArM itself, but by companies selected in a Europe-wide tender procedure and commissioned by the cannabis agency. The procedure takes into account all drug and narcotic drug requirements.
The tender procedure has now been published in the Official Journal of the European Union.
The following link leads to the tender documents: Supplement to the Official Journal of the European Union
Communication in connection with the tendering procedure takes place exclusively through the electronic award platform.
Cannabis will be grown exclusively for medical purposes. It is therefore a medicine. Only cannabis grown according to the guidelines of the Good Agricultural and Collection Practice (GACP ) will be used, which corresponds to the specifications of the Monograph “Cannabis Blossoms” ( DAB ) and the Requirements of the other relevant monographs and guidelines. This ensures the availability of cannabis for medical purposes in reproducible quality in accordance with drug laws. The cannabis for medical purposes is also subject to the provisions of the law on narcotic drugs.
The cannabis agency will set a manufacturer’s fee and sell the cannabis to cannabis drug manufacturers, wholesalers or pharmacies. The cannabis agency is not allowed to make any profits or surpluses. In the case of pricing, however, the personnel and material costs incurred by the BfArM are taken into account. However, the cannabis agency has no influence on the actual sales price in the pharmacy. The distribution channels of manufacturers and dealers will comply with the legal regulations and are thus identical with the regulations for the distribution of other drugs containing narcotic drugs.
Here you can find information about the cannabis agency and the cannabis cultivation of cannabis controlled by the cannabis agency for medical purposes: