Aphria, Tilray Subsidiary, Secures New Medical Cannabis Production License in Germany

Aphria RX, a subsidiary of the Canadian company Tilray based in Neumünster, Germany, announced on Monday that it has received a license for medical cannabis cultivation under the new German cannabis law that took effect on April 1.

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Previous Licensing and Market Position of Aphria

Aphria previously held a medical cannabis cultivation license in Germany, granted in May 2019, which was limited to the production of a total of five batches (1,000 kilograms). It was also the only authorized producer in Germany allowed to cultivate all three varieties of medical cannabis approved by the German Federal Institute for Drugs and Medical Devices (BfArM).

In addition to Tilray, Canadian cannabis company Aurora and German company Demecan have been authorized since 2019 to cultivate a combined total of 10,400 kg of medical cannabis in Germany.

Aphria merged with Tilray in 2021.

New Provisions for Medical Cannabis

The new law, approved on February 23, removed cannabis from the list of controlled substances, legalized the possession of up to 25 grams by adults, authorized cannabis cultivation clubs—one of which has already received approval—and amended the German Medical Cannabis Law (MedCanG).

Key Amendments to MedCanG

The amendments to MedCanG now allow companies like Aphria RX who wish to cultivate medical cannabis in Germany to:

• “Market and distribute their own harvests,” though they will be subject to inspections by BfArM and other authorities.
• Continue to obtain authorization from BfArM without needing to adhere to the European Union’s “tender procedure.”
• Maintain compliance with quality requirements set by pharmaceutical legislation, including Good Agricultural and Collection Practices (GACP), Good Manufacturing Practices (GMP), and Good Distribution Practices (GDP).

Impact on Aphria Operations

The license obtained by Aphria now allows the company to “cultivate and manufacture a wide commercial range of medical cannabis, thereby providing patients with better access to high-quality medical cannabis produced in Germany,” according to the company statement.

Aphria plans to significantly increase its production capacity and expand its strains from three to 31.

Industry Reactions and Future Outlook

Irwin Simon, CEO of Tilray, stated during a conference call on April 9 that while the new cannabis law does not create a commercial recreational market, “the new opportunities for Tilray primarily stem from the removal of medical cannabis from controlled substances.”

“This change in classification is expected to greatly expand the medical cannabis market in Germany,” he continued, “as it will allow more doctors to prescribe medical cannabis to patients more easily and could enable broader health insurance coverage.”

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(Featured image by Elsa Olofsson via Unsplash)

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