AgraFlora Organics International Inc (CSE:AGRA) (OCTMKTS:AGFAF) said Wednesday that its wholly-owned subsidiary Farmako GmbH has submitted an application to the regional authorities in Germany for EU Good Manufacturing Practice (EU-GMP) certification, and a manufacturing and import authorization (MIA) license under the German Medicinal Products Act.
In a statement, the diversified international cannabis company said that with the submission of its application documents, it anticipated the EU-GMP and MIA licensing processes to be completed by the summer.
If the company is successful in its bid to win MIA authorization and GMP certification, Farmako will be able to import medical cannabis products from outside the European Economic Community. The company said this will “dramatically increase” supply and allow Farmako greater flexibility — a key milestone as it scales its German and European medical cannabis distribution business.
“Germany has put in place the highest standards in the world to ensure the safety of the medical patient, as well as bolster trust that patients, physicians and pharmacists have in the program. As a result, it is very challenging for new businesses to enter the market which has created a limited amount of medical cannabis supply for the German marketplace,” said Farmako CEO Katrin Eckmans.
“Our submission is a critical step towards obtaining the required EU-GMP certification and MIA authorization that will allow Farmako to greatly increase the supply and available portfolio range of high-quality medical cannabis products available to German patients.”
Farmako is among a limited group of German companies awarded special authorization by the German Federal Institute for Drugs and Medical Devices for the distribution of medical cannabis flowers that have undergone ionizing radiation treatment. If this is combined with the EU-GMP and MIA authorization, Farmako will be a leader in Germany with its ability to develop a strong supply chain.
Farmako GmbH is a leading European medical cannabis distributor, headquartered in Frankfurt, with affiliated companies in the UK, Luxembourg and Denmark. The company has a distribution network of 19,800 pharmacies in Germany covering 100,000 patients.
Germany is expected to be Europe’s largest medical cannabis market and has the potential to develop into one of the world’s largest markets for medical cannabis.
Farmako currently holds a certification in accordance with EU Good Distribution Practice, a wholesale authorization under AMG and a controlled drug license under the German Controlled Drug Law, under which the company has been trading medicinal cannabis products from European manufacturers to German pharmacies since March 2019.
Farmako was awarded its UK license less than a month ago after it successfully completed an inspection in December by the UK Home Office. This makes Farmako an early mover in the UK’s rapidly developing medical cannabis market.
A diversified cannabis company, Vancouver-based AgraFlora owns an indoor cultivation facility in London, Ontario, as well as the edibles manufacturing facility in Winnipeg. The company is also a joint venture partner in Propagation Services Canada Inc, which operates a 2.2 million-square-foot greenhouse complex in Delta, British Columbia.
AgraFlora’s wholly-owned subsidiary Farmako GmbH is scaling towards its goal of being Europe’s leading distributor of medical cannabis.
Contact the author Uttara Choudhury at [email protected]
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