BfArM: Federal Ministry for Drugs and Medical Devices

The Federal Institute for Drugs and Medical Devices(BfArM) is a higher federal authority within the portfolio of the Federal Ministry of Health. It monitors the safety, quality and efficacy of medicinal products and medical devices in Germany. The BfArM plays a central role in the approval of medicinal products and ensures that patient safety is guaranteed.

Tasks of the BfArM briefly explained

The BfArM has a wide range of tasks that focus on safeguarding healthcare. From the review of medicines to the evaluation of medical devices – the Institute makes a significant contribution to public health.

  • Authorization of medicinal products
  • Monitoring of medical devices
  • Research and consulting

BfArM in the cannabis legalization process

The Federal Institute for Drugs and Medical Devices (BfArM) plays a central role in the regulation of medical cannabis in Germany and supports the implementation of the new legal regulations on cannabis legalization.

  1. Approval and monitoring
  2. Regulation of cannabis clubs
  3. Addiction prevention and research

Approval and monitoring

The BfArM is responsible for the approval of medicinal cannabis products and monitors their quality, safety and efficacy. Since the legalization of medicinal cannabis in 2017, the BfArM has coordinated safe access for patients.

Regulation of cannabis clubs

With the legalization of recreational cannabis from 1 April 2024, the BfArM will also play an important role in the regulation of so-called cannabis clubs. Under the supervision of the BfArM, these clubs are allowed to supply cannabis to members for home cultivation.

Addiction prevention and research

In addition to the authorization of cannabis products, the BfArM promotes measures to prevent addiction and supports research projects that deal with the effects of cannabis on health. It works closely with other health authorities to ensure that cannabis is consumed responsibly and under safe conditions.

In this way, the BfArM makes a decisive contribution to ensuring the safe and controlled use of cannabis in Germany.

  • Cannabis legalization

BfArM summarized

The BfArM is an indispensable institution that ensures the safety of medicinal products and medical devices. It ensures compliance with high standards and thus protects the health of the population.

Did you know? EU approval

The BfArM works closely with other European regulatory authorities to review and approve medicines throughout Europe.