Medical Cannabis in Germany: How to Grow, Sell and Import

Medical cannabis in Germany, as defined in § 2 MedCanG, encompasses various parts of the Cannabis plant cultivated under state control per international regulations. This includes delta-9-tetrahydrocannabinol (THC), dronabinol, and related preparations. § 3 MedCanG stipulates that medical cannabis can only be dispensed to end users through pharmacies upon presentation of a medical prescription. Consequently, medicinal cannabis is either produced by pharmacies themselves or supplied to them for distribution to patients with valid prescriptions. Notably, it is cultivated exclusively for medicinal purposes and is therefore classified as a prescription-only medicinal product.

Importantly, medical cannabis is exclusively cultivated for therapeutic use and is thus classified as a prescription-only medicinal product. It no longer requires a special prescription for narcotics; instead, it is prescribed using a standard prescription format. Furthermore, the dispensing voucher procedure, which added bureaucratic hurdles, has been abolished, streamlining the process for patients to access medical cannabis.

At Schlun & Elseven Rechtsanwälte, we are ready to guide clients through the legal intricacies surrounding medical cannabis in Germany. Our firm is dedicated to providing tailored legal support to clients in this rapidly evolving sector, ensuring compliance with regulations and facilitating informed decision-making in this complex area of law.

In Germany, authorisation to cultivate, harvest, process, store, package, and supply medical cannabis to pharmacies is granted by the Cannabisagentur (Cannabis Agency), operating under state control. Housed within the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn, the Cannabis Agency oversees the entire production chain, ensuring compliance with stringent quality standards. Acting as both a pharmaceutical entrepreneur and wholesaler, the Cannabis Agency plays a pivotal role in maintaining the integrity of the medical cannabis supply chain.

It’s important to note that the BfArM itself does not carry out cultivation; it is done by companies selected through a rigorous Europe-wide tendering process and commissioned by the Cannabis Agency. These companies must adhere to strict pharmaceutical quality requirements throughout all stages of production, including cultivation, harvesting, trimming, drying, and storage. Companies seeking authorisation to cultivate cannabis for medicinal and medical-scientific purposes must submit a comprehensive application to the Cannabis Agency. This application includes documentation outlined in § 7 Medical Cannabis Act (MedCanG) and a valid manufacturing license/GMP certificate from the competent state authority.

At Schlun & Elseven Rechtsanwälte, our legal team is available to guide companies through the requirements of this application process. During the application, applicants need to provide information on some of the following matters:

• Personal information: Full name, address, and contact details of the applicant. Personal information of all responsible persons involved in the application, including their full names, addresses, and contact details. Company name and address, if applicable
• Certificate of Good Conduct.
  
• Proof of expertise.
• Description of business premises.
• Purpose of handling cannabis.

Once authorised, the Cannabis Agency oversees the purchase of cannabis and sells it to pharmacies at a fixed manufacturer’s retail price. A logistics company manages distribution to pharmacies selected through a rigorous European selection process, ensuring the efficient and secure delivery of medical cannabis to end-users.

At Schlun & Elseven Rechtsanwälte, we provide strategic legal counsel to companies dealing with the complex regulatory landscape of medical cannabis cultivation and production in Germany. Our expertise assists clients in obtaining necessary authorisations, ensuring compliance with regulations, and mitigating legal risks associated with this burgeoning industry.

A comprehensive understanding of the regulatory framework is essential for those seeking to conduct business with the import and export of medical cannabis in Germany. Medical cannabis can be imported from any country that maintains a government agency overseeing its cultivation for therapeutic purposes in compliance with international conventions. However, importing from third countries to the European Union necessitates an import license as per § 72 Arzneimittelgesetz – Medicinal Products Act – (AMG), which typically replaces the wholesale permit. Additional authorisations may be required on a case-by-case basis.

Those seeking to become involved in the import/export process must submit suitable applications to the German Federal Institute for Drugs and Medical Devices. The application includes import and export forms, ensuring compliance with relevant regulations and procedures. At Schlun & Elseven Rechtsanwälte, our team is available to advise on all matters relating to submitting the necessary forms and documents. Our lawyers are particularly adept at guiding international clients through the process.

Importing cannabis for medicinal or medical-scientific purposes remains viable with the appropriate authorisation under § 4 MedCanG (“(2) The Federal Institute for Drugs and Medical Devices may grant a licence for the handling of cannabis for medical-scientific purposes for scientific purposes or only in exceptional cases for other purposes in the public interest”). However, adherence to the Narcotics Foreign Trade Regulation is imperative throughout the import, export, and transit processes.

Under § 4 MedCanG, a license from the Federal Institute for Drugs and Medical Devices is mandatory for individuals or entities engaging in various activities related to medical cannabis. This includes cultivation, production, trade, import, export, dispensing, selling, or any other form of market placement, acquisition, or obtaining of cannabis for medical purposes or medical-scientific purposes. Therefore, authorisation is necessary for any handling of medical cannabis in Germany, encompassing activities such as extraction of cannabinoids, as defined within the scope of manufacture.

Exceptions to the licensing requirement are outlined in § 5 MedCanG. Pharmacies, for instance, are exempt from the licensing obligation due to their compliance with pharmaceutical and pharmacy regulations. These entities have demonstrated expertise in handling medicinal products and narcotic drugs, warranting an exemption from the licensing requirement.

The content of the license, as delineated in § 6 MedCanG, is comprehensive. It must specify the location of the business premises, enumerate permitted activities, and detail the type of cannabis that may be handled. Additionally, the person responsible for the license must meet the reliability criteria as per § 9 MedCanG. Furthermore, licenses may be granted for a limited period or subject to conditions deemed necessary under § 10 MedCanG. This flexibility allows for tailored licensing arrangements based on specific requirements or circumstances. Understanding these authorisation requirements is pivotal for individuals and entities handling medicinal cannabis, ensuring compliance with legal obligations and facilitating smooth operations within the regulatory framework.

At Schlun & Elseven Rechtsanwälte, our team is ready to advise you on all related matters.