BfArM awards first contracts for Cannabis

The German Federal Institute for Drugs and Medical Devices (BfArM) has awarded the first contracts for the cultivation of medical cannabis in Germany:

• Aurora Produktions GmbH was awarded a contract for five lots;
• Aphria Deutschland GmbH was awarded a contract for four lots.

Since BfArM awarded the contracts on 17 April 2019, the cultivation of cannabis in pharmaceutical quality in Germany can now commence in accordance with the requirements of the narcotics and drug law. The tender covers a total of 10,400 kg of cannabis, spread over four years with 2,600 kg each. It is divided into 13 lots of 200 kg per year. This means that the contract has now been awarded for the cultivation and harvesting of a total of 7,200 kg of cannabis. The BfArM expects the first harvest by the 4th quarter of 2020.

However, four out of the 13 lots put out to tender could not yet be awarded because an unsuccessful tenderer requested review from the Public Procurement Chamber. According to the BfArM, it has not yet been determined when the contract for these four lots can be granted. Cannabis is currently imported into Germany for medical purposes from abroad (e.g. Canada, Holland). The import will continue to be possible in the future. However, the BfArM has no central control function for the import. This lies in the responsibility of the GMP/GDP monitoring authorities of the countries (federal states) that issue the import license (in addition, an import license according to the German narcotics law is required in Germany).

The situation is different with the planned cultivation of medicinal cannabis in Germany. The BfArM has set up a Cannabis Agency together with the law that came into force on 10 March 2017 to amend the law on narcotics and other regulations. The Cannabis Agency will purchase, take possession of and sell the cannabis cultivated in Germany for medical purposes to manufacturers of pharmaceutical products, wholesalers or pharmacies in accordance with the international legal requirements of the United Nations Single Convention on Narcotic Drugs of 1961. However, the cannabis harvest is neither brought into the BfArM nor stored there.