AgraFlora Organics International's wholly owned subsidiary Farmako GmbH has submitted its application documents to the respective regional authorities in Germany for the granting of EU Good Manufacturing Practice (“EU–GMP”) certification as well as a Manufacturing and Import Authorization (“MIA”) under the German Medicinal Products Act (“AMG”). The Company expects the EU-GMP and MIA licensing processes to be completed by summer 2020.
"If successful in obtaining the Manufacturing and Import Authorization and GMP Certification Farmako will be able to commence import of medical cannabis products from outside the European Economic Community (“EEC”) which will dramatically increase the availability of supply and allow Farmako more flexibility – an important milestone as it scales its German and European medical cannabis distribution business," the team with the company explains.
“Germany has put in place the highest standards in the world to ensure the safety of the medical patient as well as bolster trust 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 Katrin Eckmans CEO of Farmako. “Our submission is a critical step towards obtaining the required EU-GMP certification and Manufacturing and Import Authorization that will allow Farmako to greatly increase the supply – and thus the available portfolio range of high quality medical cannabis products available to German patients.”
"Farmako is also one of a limited group of German companies awarded special authorization by the German Federal Institute for Drugs and Medical Devices (“BfArM”) for the distribution of medical cannabis flowers that have undergone an ionizing radiation treatment. In combination with the EU-GMP and Manufacturing and Import Authorization Farmako will be a leader in Germany with respect to the breadth of supply chain it can develop. Farmako’s Management believes additional supply options will allow the company to rapidly scale its business through broader range of medical products backed by larger volumes as compared to what has been available historically."
Farmako currently holds a certification in accordance with EU Good Distribution Practice (“GDP”) a wholesale authorization (“WDA”) under AMG and a controlled drug license under the German Controlled Drug Law (“BtMG”) under which the company has been trading medicinal cannabis products from European manufacturers to German pharmacies since March 2019.
"Furthermore the EU-GMP Certification and Manufacturing and Import Authorization license extension is an important step for Farmako with regards to broader integrated European strategy. Farmako recently announced via a subsidiary that it has received all licensure necessary to conduct medical cannabis distribution in the UK. Farmako was awarded its UK licence less than one month ago following the successful completion of its inspection by the UK Home Office in December 2019. The UK is a developing medical cannabis market where Farmako is an early mover."
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AgraFlora Organics
agraflora.com