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Cannabis Country Report Germany – How to get a license? How to export products abroad?

February 15, 2022 | Category : Analysis and opinion | Posted By : Deon Maas

This information serves as an introduction to potential cannabis cultivators in Germany. This information is relevant to all cultivators. The information was correct at the time of publication.

Cannabis Licences in Germany

The new government that took over in Germany in December 2021 made it an election promise that they will legalise adult recreational use of cannabis, reversing the previous government stance on it. The legislation was expected to be presented during the first legislative session of 2022. The governing coalition—comprised of the Social Democratic Party of Germany (SPD), the Free Democratic Party (FDP) and the Greens said that it will be “introducing the controlled distribution of cannabis to adults for recreational purposes in licensed shops.” After a huge media blitz and speculation about the imminent changes, progress was stopped for unknown reasons. The SDP decided that “currently it is not a good time for a cannabis bill” and the FDP stated that “the fight against the pandemic has priority”.

  • The International Cannabis Business Conference estimates that Germany will become the largest medical cannabis market in Europe by 2023
  • Over a million German patients will have access to medical cannabis by 2024, and the German medical market alone will be worth €7.7 billion by 2028 
  • German company Cansativa has become the sole distributor of all cannabis grown in Germany 
  • Cannabis is currently being imported into Germany from abroad 
  • BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte // Federal Institute for Drugs and Medical Devices) has now set the wholesale price for medical cannabis cultivated in Germany at €4.30 per gram 
  • One of the biggest hurdles for North American medical cannabis companies to enter the European medical cannabis market is getting EU-GMP (Good Manufacturing Practice) certification, which defines all processes, including drying, processing, extraction, and distribution of medical cannabis products 

The German government legalised cannabis for medical purposes in March 2017. They also established a cannabis agency as part of the German Federal Institute for Drugs and Medical Devices (BfArM). Shortly after that, they entered into the public tender process during which companies could apply for a cannabis cultivation license. The tender process was set up in two steps. First, applicants had to qualify for growing of cannabis in Germany. That was the pre-condition; demonstrating the ability and experience to grow cannabis in Germany. But, there was a problem: No company in Germany had the necessary experience and therefore couldn’t qualify on their own. So the BfArM agreed that companies were allowed to team-up with pre-established international cannabis growers or other experienced plant-farmers. 

The Federal Agency in Germany that runs cannabis growing 

  • BfArM is responsible for the issuing of licenses to cultivate, produce, trade, import, export, deliver, sell or buy narcotics and for the tender process regarding the cultivation of cannabis 
  • The cannabis cultivated on behalf of the Cannabis Agency of the BfArM is used exclusively for medical purposes and is sold in pharmacies. When cultivating this cannabis and placing it on the market, all drug and narcotics law requirements must be met. Only cannabis will be used that has been grown in accordance with the requirements of the “Good Agricultural and Collection Practice, GACP” and that meets the requirements of the relevant guidelines 
  • The Cannabis Agency will buy and take possession of the medical cannabis grown in Germany in accordance with the international legal requirements of the United Nations Uniform Convention on Narcotic Drugs of 1961 
  • The BfArM is not allowed to make any profits or surpluses 

How to get a cannabis cultivation license 

  • The government does not issue cannabis cultivation licenses, they work through a tender system in which companies are invited to submit paperwork. Once they have reviewed the paperwork a certain number of companies are issued licenses for a specific amount of cannabis over a specific period of time after which the tender process is repeated 
  • The Agency holds a Europe-wide public tender process 
  • They issue delivery contracts for limited quantities and periods of time 
  • The Agency purchases the exact amount of cannabis stipulated in the contract, from the grower 
  • BfArM sells and distributes the cannabis 
  • Until the next tender opens, only the previously selected growers may cultivate 
  • There are currently three companies permitted to grow in Germany, Aurora Cannabis and Aphria RX are based in Canada, while the other is Germany-based startup Demecan 

In order to be one of the applicants for the tender, the company needs to fulfil the following criteria: 

  • No subcontracting is allowed 
  • Provide documentation to prove that they are qualified to manufacture 
  • Provide documentation to prove that they have sufficient security 
  • Authorisation to manufacture medicinal products 
  • Have a license for handling narcotics 
  • Authorisation to use the land where their site is located 
  • Industry knowledge and professional experience 

The Cannabis Agency awards contracts to growers in Germany for the supply of cannabis under civil law. The invitation to tender and the contracts with the growers include the type and quantity of cannabis required. The successful bidders have to fulfil their performance obligations, organise the cultivation as well as the harvest and apply for the official approval required for this.  

The procedure will be carried out by the Cannabis Agency. A licence issued by BfArM shall be required for those who grow, manufacture, trade with narcotics, or – without trading with them – import, export, transfer, sell, otherwise market, or acquire them. The applicant has to provide specific documentation, e.g. proof that the persons in charge have the required expertise, or a description how the facility is secured against unauthorized removal of narcotic drugs. Application requirements are fully listed in sec. 7 of the German Narcotic Drugs Act. 

Because cannabis is only cultivated for medical purposes and is therefore considered to be a medicinal product, the cultivator also has to obtain authorisation to manufacture medicinal products.  

In terms of personal and material requirements, the bidder has to provide proof of the required expertise. The permission granted by the Cannabis Agency are hence tailored to a circle of bidders with industry knowledge and professional experience. Once the approval has been granted, the manufacturer must take the necessary safety measures, keep ongoing records and provide notifications to the competent authority. 

Regarding the requirements for the growing process itself, cannabis must be cultivated in accordance with the Good Agricultural and Collection Practice and meet the requirements of the Cannabis Flower Monograph (German Pharmacopoeia / Deutsches Arzneimittelbuch – DAB).  

CBD/THC: The cultivation of industrial cannabis by agricultural undertakings does not require authorisation when certified seeds of the THC content is below 0.2%. It is only necessary to notify the authorities. CBD as a pure substance is not defined as a narcotic in the German Narcotics Act. However, products with CBD have recently been considered to be illegal by prosecutors and criminal courts if they contain more than 0.2% THC. Prosecution also happens if the THC count is lower than 0.2% if the product is not used for scientific or commercial purposes. 

Some background on Germany

Longform name: Federal Republic of Germany/ Bundesrepublik Deutschland 
Legislation: Federal parliamentary republic
Ruling party:  SPD
Currency: Euro

History

Archaeological digs in Thuringia show that cannabis was present at least 7,500 years ago in Germany. Cannabis seeds were discovered in cave dwellings, indicating that these ancient people may have used them in domestic life. Another dig in Wilmersdorf (now part of Berlin) uncovered cannabis seeds in a funerary urn, dating back 2,500 years. There’s plenty of evidence to suggest that it played an important part in rural German life after this too. 12th century texts, written by the Benedictine abbess Hildegard von Bingen, claim that cannabis “reduces the bad juices and reinforces the strong ones”, and that it could be used to treat headaches. Her research was respected by many, although the Catholic Church was against the use of the drug. By the 1400s, use of cannabis for medicinal purposes was well-established. Although the Inquisition tried to stamp out use of traditional herbalism, its practice persisted in Germany. This is largely thanks to the medieval universities, who went to great effort to preserve the country’s historic practices. During this period, cannabis oil was widely used to treat inflammation, coughs, parasitical infections, gonorrhoea and more. 

The trading expeditions to Africa and Asia (around the 1500s) were also significant. Sailors returned with ‘Indian Hemp’; much more potent strains of cannabis. These too were incorporated into medical practice, but their use wouldn’t become widespread until the mid-1800s. 

Geography

The country is divided into 16 states with a fairly even distribution of people.  
The Western part of the country is economically stronger than the Eastern part.

Geographical Location:Central Europe 
Borders:Austria, Belgium, Czechia, Denmark, France, Luxembourg, Netherlands, Poland and Switzerland
Coastline:2,389 km 
Major seaports:  Baltic Sea: Kiel, Rostock 
North Sea: Bremerhaven, Brunsbuttel, Emden, Hamburg, Wilhelmshaven 
Airports with paved runways:318 
Airports with unpaved runways:221 
Agricultural land:48% 
Agriculture:milk, sugar beet, wheat, barley, potatoes, pork, maize, rye and rapeseed 
Irrigated land:6500sq km 

Weather

Weather:Temperate and marine; cool, cloudy, wet winters and summers; occasional warm mountain wind, Average rainfall 705mm/annum
Natural Hazards: Flooding

Economy

Population age:Aging population 
Youth unemployment: 6% 
GDP growth 2017: 2,91% 2018: 1,3% 2019: 0,59%
Inflation rate 2019: 1,4% 
Industrial production growth rate: 3,3% 
Labour force: 44,5 million 
Export partners: United States, France, China, Netherlands, United Kingdom, Italy, Poland, and Austria 
Export commodities: Cars and parts, packaged medicines, vaccines, industrial machinery  
Digital adoption:Digital shortcomings plague the public sector 
Banks:The banking sector lags behind international competition 

Environmental Issues

Emissions from coal-burning utilities, acid rain, sulfur dioxide emissions is damaging forests, pollution in the Baltic Sea from raw sewage, and industrial effluents from rivers in eastern Germany.

https://sensiseeds.com/en/blog/countries/cannabis-in-germany-laws-use-history/

https://www.bfarm.de/SharedDocs/Pressemitteilungen/DE/2019/pm1-2019.html

https://www.cannabisagentur.de/ 

https://www.bfarm.de/DE/Bundesopiumstelle/_node.html;jsessionid=4F516381D80181A6541BFBBC1818D235.internet542 

https://www.cansativa.de/en/ 

https://cms.law/en/int/expert-guides/cms-expert-guide-to-a-legal-roadmap-to-cannabis/germany 

https://www.gesetze-im-internet.de/btmg_1981/ 

https://www.gesetze-im-internet.de/amg_1976/ 

https://www.gesetze-im-internet.de/sgb_5/ 

https://www.theworldlawgroup.com/news/2020-global-cannabis-guide-germany 

Comments

4 thoughts on “Cannabis Country Report Germany – How to get a license? How to export products abroad?

  1. What about imported cannabis flower? Does BfArma has to distribute those flowers trough pharmacies also?

    1. Hello David. Thanks for your question. Yes, but it needs to be approved by the opium board and corresponding licensing needs to be in place. Best, your Cannavigia team

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