Germany has yet to legalize recreational cannabis, but is there room for more medical cannabis growers in their market?
Germany is thought to be a template for cannabis regulation in Europe. Their medical marijuana products must be produced under GACP and EU-GMP standards for pharmaceuticals. But getting a cannabis cultivation license in Germany remains very difficult. To start, they do not actually issue licenses. Instead, the government works with cannabis growers through contracts.
In 2019, orders for a total of 10,400 kg were awarded for four years in a Europe-wide award procedure.-from “Cannabis Agency” by BfArM
Cannabis Legalization in Germany
Cannabis for recreational and adult-use is prohibited in Germany, but medical cannabis was legalized in 2017. The 2017 legislation expanded options for prescribing medical cannabis in the form of dried flower and cannabis extracts. German cannabis products must be produced to meet pharmaceutical quality standards that are set out in the European Good Manufacturing Practices (EU-GMP). Cannabis cultivators must also follow Good Agricultural and Collection Practice (GACP). The Federal Institute for Drugs and Medical Devices (BfArM) has a “Cannabis Agency” that oversees the contacting, production, and distribution of cannabis in Germany.
Drug Scheduling of Cannabis in Germany
Anlage I controlled substances are not allowed to be traded, sold, transported, or produced without special permission from the German government. Marijuana is classified under Anlage I except for medical cannabis. Medical cannabis is classified as Anlage III which means that you need a prescription to obtain it.
Personal Use Cannabis Regulation in Germany
Outside of Germany’s medical marijuana program, cannabis is considered to be illegal and punishable. Anecdotally, there are claims that possession of small amounts of illegal cannabis in Germany may be let off. However, there are hefty fines and jail time that could be faced if you are caught. Prosecutors and courts do have some discretion but the amount of leniency can change depending on which German state you are in.
Medical Marijuana in Germany
Germany won’t likely see recreational cannabis legalization for some time since it has recently fallen out of favour. Voter preferences are very close with just 51% in opposition though. There are just three current companies contracted to produce cannabis for Germany. Those are Canadian firms Aphria and Aurora, and German company Demecan. They are allowed to produce three types of cannabis:
- Type 1: 18% to 22% THC with less than 1% CBD
- Type 2: 12% to 16% THC with less than 1% CBD
- Type 3: 5% to 9% THC with 5% to 9% CBD
Medical Marijuana Regulation
According to a press release from BfArM in 2019, German cannabis growers must follow GACP and EU-GMP regulations in addition to the requirements of the monograph of the German Pharmacopoeia “Cannabis Flowers” (DAB). When contracted cannabis growers produce cannabis products they are sold to the German Cannabis Agency that operates under BfArM. The agency sets the price of cannabis and is responsible for its sale and distribution to processors, manufacturers, wholesalers, and pharmacies. In order to grow cannabis in Germany, BfArM must grant you a contract to cultivate cannabis for them. BfArM is not allowed to generate any profits or surpluses.
[Germany] has created the Cannabis Agency (in German “Cannabisagentur”, a subdivision of the Federal Institute for Drugs and Medical Devices – BfArM), which controls cultivation, harvesting, processing, quality control, storage, packaging and distribution to wholesalers and pharmacists or manufacturers.-from “10 Q&A’s related to Medical Cannabis in Germany (in English)” by Margret Knitter and Dr. Ilja Czernik, April 27 2020
How to Get a Cannabis License in Germany
You may be surprised to learn that 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:
- BfArM holds a Europe-wide “public tendering process” (contract bidding)
- BfArM issues “delivery contracts” for limited quantities and periods of time
- The Cannabis Agency of BfArM purchases the cannabis, it cannot have excess amounts
- The Cannabis Agency sells and distributes the cannabis; the Federal Opium Agency oversees cannabis importation
- 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
What Does Your Seed-to-Sale Platform Need to Track?
If you are cultivating cannabis in Germany (or plan to), you’ll be relieved and excited by the innovative GrowerIQ seed-to-sale software! EU-GMP has very strict recordkeeping requirements and quality assurance standards that need to be met. GrowerIQ seed-to-sale software has everything you need, including tracing and tracking cannabis material, storing reports and documents, and the ability to have built-in quality assurance checks. GrowerIQ is cultivation software, quality management software, recordkeeping software, and an ERP all wrapped into one software suite. While it has made a splash in the thriving Canadian cannabis market, it is robust and capable of meeting the high standards of EU-GMP as well.
Find Out More
Let’s discuss your project in order to customize a comprehensive plan to help you become a licensed producer. Click the button below to get in touch with one of our experts, and find out how GrowerIQ can help your business reach its maximum potential.
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