German cannabis growers are selected – but the amounts of cultivated cannabis won’t be sufficient

05/24/2019 | Dr. Stefan Stromeier
Stromeier

Dr. Stefan Stromeier
Senior Consultant

The course has been set for the cultivation of medicinal cannabis in Germany. The cannabis agency at the German Federal Institute for Drugs and Medical Devices (BfArM) has granted three producers a total harvest of 2.6 tonnes of medicinal cannabis per year. The winners of the tender procedure are a German start-up company (part of a Canadian joint venture) and two German subsidiaries of Canadian cannabis manufacturers that will now also be employing their expertise in Germany. However, it is already clear that the German production volume will not be sufficient to cover the foreseeable demand. Germany will therefore remain dependent on imports for some time to come, with the export of “Cannabis Made in Germany” a similarly distant reality.

Exponential market growth 

Following medical cannabis’ clearance as a prescribable narcotic drug, the market has continued to grow exponentially with no end in sight. In order to establish cannabis as a serious evidence-based drug, intensive research is also being carried out into its effects, efficacy, side effects, therapeutic potential, (new) ranges of indication and dosage forms.

On the side of the growers and extract producers, it is certainly no coincidence that the lots went to companies with Canadian roots and experience in cannabis cultivation. The German pioneer in the industry, Bionorica, recently sold its division – to a Canadian company.

The development of the market and commodity prices will depend on future political decisions. Despite these developments, market experts are already predicting that the harvest volumes granted in Germany will not be sufficient to meet the rapidly growing demand. No more than 2.6 tonnes of German cannabis will be available per year, and it will not be coming on the market until the end of 2020. That is because the German plantations are still currently under construction, with the plants still needing to be grown, harvested and processed first.

Cannabis imports remain necessary

According to the statistical trend from the past two years, it is foreseeable that demand will soon exceed this permissible German harvest. Import to Germany specifically, and to the European Union (EU imports) in general, will therefore remain a topic of interest for pharmaceutical companies and manufacturers of health products, who also want a share of this growth market.

We at Diapharm currently support numerous companies through advice and implementation regarding

  • EU imports,
  • GACP/GMP conformity,
  • Storage,
  • Analytics,
  • Marketing in accordance with the German Narcotic Drugs Act (BtMG),
  • GDP guidelines and
  • GAP analyses – marketability of finished products.

As an active substance, cannabis cannot be compared to other herbal medicinal products. The German Narcotics Drugs Act (BtMG) and the associated safety guidelines impose strict requirements that include an import permit from the competent authorities of the countries of origin, a further import permit under German narcotics law and a special import analysis. Specialised know-how is therefore a must. In addition, companies wishing to participate in the cannabis boom will also need the capacity to respond quickly to any potential changes in regulatory and political requirements. We at Diapharm are here to help you in your undertaking. Contact us!

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