BfArM starts Sale of medical Cannabis "Made in Germany"

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Finally it´s done: The German Federal Institute for Drugs and Medical Devices (BfArM) has started the state sale of medical cannabis from German cultivation. However, importation remains possible.

Cultivation of medical cannabis in Germany

Medical cannabis is not cultivated in the BfArM or by the BfArM itself, but by currently three companies (Aphria RX GmbH, Aurora Produktions GmbH and Demecan GmbH), which were selected in a tender procedure and commissioned by the Cannabis Agency. The German cultivation quantity of 10400 kg of medical cannabis commissioned by the BfArM is spread over four years with 2600 kg each year. Determining the tender quantity, it was also taken into account that medical cannabis can additionally continue to be obtained from importers.

The Cannabis Agency

The Cannabis Agency was established in 2017 as a new specialist area in Division 4 at the BfArM when the Act Amending the Narcotics Law and Other Regulations (so-called "Cannabis as Medicine" Act) came into force. Physicians can prescribe medical cannabis or cannabis extract in pharmaceutical quality on a narcotic prescription. The Cannabis Agency is responsible for the "controlled cultivation, harvesting, processing, quality testing, storage, packaging and distribution" of medical cannabis flowers (grown in Germany) to pharmacies in Germany.

Quality Requirements

Cannabis is currently cultivated in Germany exclusively for medical purposes. It is therefore a prescription drug. It is additionally subject to the narcotics law regulations (BtMG). The pharmaceutical quality of the cannabis flowers in reproducible quality and according to drug law specifications is ensured by compliance with

• Good Agricultural and Collection Practice (GACP),
• Good Manufacturing Practice (GMP),
• and the specifications of the Pharmacopoeias (Ph. Eur., DAB)

Ordering, Distribution & Dispensing

Pharmacies can obtain medical cannabis in pharmaceutical quality via the Cannabis Agency portal. The medical cannabis is distributed to German pharmacies on behalf of the Cannabis Agency via a GMP- and GDP-certified distribution company. Sales from the BfArM to pharmacies are made at a price of 4.30 euros per gram. The dispensing price in the pharmacy then results from the consideration of surcharges (e.g. formulation surcharge, surcharge for packaging) and, if applicable, further fees (e.g. BTM fee). In addition, there are new special PZNs for cannabis flowers from German cultivation.

DAC / NRF Formulation Standards

In the DAC / NRF (German Drug Codex / National Drug Formulary), there are currently four formulation standards for use in pharmacies for the cannabis flowers:

• Cannabis flowers for inhalation after vaporization (NRF 22.12.)
• Cannabis flowers in single doses (~10 mg – ~100 mg) for inhalation after vaporization (NRF 22.13.)
• Cannabis flowers for tea preparation (NRF 22.14.)
• Cannabis flowers in single doses (0,25 g / 0,5 g / 0,75 g / 1 g) for tea preparation (NRF 22.15.)

The DAC / NRF also includes a formulation standard for cannabis extract:

• Oily cannabis oil resin solution 25 mg/mL Dronabinol (NRF 22.11.)

Imports

Until now, German pharmacies have obtained pharmaceutical-grade medical cannabis from imports. This will still be possible. Unlike cultivation in Germany, the import is not controlled in quantity by the BfArM.

For more information on the start of sales of medical cannabis to pharmacies in Germany, please see the BfArM Press Release Number 6 / 21 from 7 July 2021 (in German).