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Federal Republic of Germany

Regulatory Framework

Recent legislative changes in Germany have introduced a regulated framework for both medical and recreational cannabis. While the Federal Institute for Drugs and Medical Devices (BfArM) oversees aspects of drug safety and medical devices, specific agencies responsible for the oversight of medical cannabis might differ and are aligned with broader health regulatory frameworks. [14] [15].

The regulatory oversight for cannabis in Germany, both medical and recreational, is expected to be primarily coordinated by the German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). The Federal Institute for Drugs and Medical Devices (BfArM), part of the Federal Ministry of Health, is expected to be responsible for regulating quality control, overseeing medical cultivation operations. However verified information for these departments is not available [1][2][11][13].

Legal Status

Market Status Act/Law Year
Adult-Use Legal Cannabisgesetz (Cannabis Control Bill) [14][15][18] 2024 [8]
Medical Legal Cannabis als Medizin (Cannabis as Medicine) [16] [17] 2017 [3]
Homegrow Legal Cannabisgesetz (Cannabis Control Bill) [3][4][14][15][18] 2024 [8]

Track-and-Trace

Germany utilizes regulatory oversight for medicinal cannabis through its federal agencies, it does not employ a comprehensive "track and trace" system as seen in some other regions, particularly for the end-to-end lifecycle of cannabis products.

Licensing

Germany does not issue actual cannabis cultivation licenses. Instead, they work through a system of contracts. The Cannabis Agency is a division of the BfArM department of Special Therapies and Traditional Medicines. Here is an overview of their contracting process:

  1. BfArM holds a Europe-wide “public tendering process” (contract bidding)
  2. BfArM issues “delivery contracts” for limited quantities and periods of time
  3. The Cannabis Agency of BfArM purchases the cannabis, it cannot have excess amounts
  4. The Cannabis Agency sells and distributes the cannabis; the Federal Opium Agency oversees cannabis importation
  5. Until the next bidding opportunity, only the previously selected contractors can cultivate or manufacture cannabis

You need to meet many requirements to bid on German cannabis contracts. Below is a summary of what the German Cannabis Agency is looking for in contractors.

Cannabis Contract Bidding Requirements

  • Applicants cannot subcontract
  • Applicants must provide documentation to show that they are qualified to manufacture cannabis and that they have sufficient security
  • Applicants must have authorization to manufacture medicinal products under sec. 13 of the German Medicinal Products Act (AMG) and have a license for handling narcotic drugs
  • Applicants must be authorized to use the land where their site is located The Cannabis Agency considers the applicant’s industry knowledge and professional experience, as evidenced by its suitability and contract requirements.

If approved, the applicant must follow requirements for safety measures (sec. 15 BtMG), record keeping (sec. 17 BtMG), and notifications to authorities (sec. 18 BtMG) in addition to GACP, EU-GMP, and specified monographs [2] [12].

Possession Limits

Market Status
Ages 18+ Up to 25 grams [4] [8]
Homegrow Three (3) plants

Medical Cannabis

The “Cannabis as Medicine” law came into force on March 10, 2017. The aim was to improve palliative care. An accompanying survey is intended to scientifically secure information on the long-term use of cannabis.

The law regulates the use of cannabis medicines as an alternative therapy for patients with serious illnesses in individual cases. The condition for this is that, in the opinion of the treating doctor, these remedies have a noticeably positive effect on the course of the disease or alleviate its symptoms. This can be the case, for example, in pain therapy, for certain chronic diseases such as multiple sclerosis or for severe loss of appetite and nausea. [16] [17]

In Germany, cannabis for medical use is regulated under several key laws, primarily governed by the German Narcotics Act (Betäubungsmittelgesetz, BtMG). This act specifies the conditions under which cannabis products, including medical cannabis, are controlled. While cannabis generally falls under strict restrictions, exceptions are made for medical use and certain hemp products under specific conditions.

Medical cannabis is specifically listed in Annex III of the BtMG, which categorizes it as a narcotic that is permissible for marketing and prescription. The oversight of medical cannabis is managed by the German Federal Institute for Drugs and Medical Devices (BfArM), an agency under the Federal Ministry of Health. This includes the Cannabis Agency (Cannabisagentur), which regulates the cultivation of medicinal cannabis in Germany, ensuring that all cultivation meets specific standards and that the product is distributed properly to authorized entities like pharmaceutical manufacturers and pharmacies.

Patients are eligible for medical cannabis if standard therapies are ineffective or inappropriate, with the potential for cannabis to positively impact their condition. Furthermore, public health insurers may cover the cost under certain circumstances, as outlined in the German Social Security Code [2][11].

Additional Resources

References