AgraFlora Subsidiary Farmako Submits Application for EU-GMP Certification and Manufacturing/Import License
11 März 2020 - 8:05AM
AgraFlora Organics International Inc.
(“
AgraFlora” or the
“
Company”) (
CSE: AGRA) (Frankfurt:
PU31) (OTCPK: AGFAF), a growth oriented and diversified
international cannabis company, is pleased to announce that the
Company’s wholly owned subsidiary, Farmako GmbH
(“
Farmako”) 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.
“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.
About Farmako GmbH
Farmako GmbH is a pharmaceutical wholesaler
based in Frankfurt, Germany. The company focuses on the
distribution of medical cannabis to pharmacies with the aim of
securing the supply for cannabis patients and closing the gap
between supply and demand for medical cannabis. Farmako is planning
to expand its business model into other European countries with a
corresponding legal basis, scaling towards its goal of being
Europe’s leading distributor of medicinal cannabis. The company
already distributes medical cannabis to pharmacies in Germany since
March 2019 and is fully licensed in the UK to start distribution
operations there in 2020. Farmako is a 100% subsidiary of AgraFlora
Organics International Inc. For more information please visit:
https://www.farmako-global.com/.
About AgraFlora Organics International
Inc.
AgraFlora Organics International Inc. is a
leading cannabis company building shareholder value through the
development of revenue generating operating assets in the global
cannabis industry. AgraFlora is focused primarily on the
Canadian cannabis industry; the world’s most advanced and regulated
legal cannabis market. Flagship Canadian assets include:
Edibles & Infusions, a fully automated manufacturing facility
in Winnipeg, MB for white-label and consumer branded edible
production; Propagation Services Canada, a large-scale commercial
greenhouse in Delta, BC focused on reshaping the Canadian flower
market with high-potency, low cost cannabis flower, and AAA
Heidelberg, a craft focused cannabis producer in London, ON. In
addition, AgraFlora’s wholly owned subsidiary Farmako GmbH is
scaling towards its goal of being Europe’s leading distributor of
medical cannabis. Farmako currently has active distribution
operations in Germany and expects to commence active operations in
the United Kingdom in 2020. For more information please visit:
https://agraflora.com/.
ON BEHALF OF THE BOARD OF DIRECTORS
Brandon Boddy Chairman & CEOT: (604) 398-3147
For additional information:
AgraFlora Organics International Inc. Tim
McNultyE: ir@agraflora.com T: (800) 783-6056 |
For French inquiries: Remy
Scalabrini, Maricom Inc.E: rs@maricom.ca T: (888)
585-MARI |
The CSE and Information Service Provider have
not reviewed and does not accept responsibility for the accuracy or
adequacy of this release.
Forward-looking Information Cautionary
Statement
Except for statements of historic fact, this
news release contains certain "forward-looking information" within
the meaning of applicable securities law. Forward-looking
information is frequently characterized by words such as "plan",
"expect", "project", "intend", "believe", "anticipate", "estimate"
and other similar words, or statements that certain events or
conditions "may" or "will" occur. Forward-looking statements are
based on the opinions and estimates at the date the statements are
made, and are subject to a variety of risks and uncertainties and
other factors that could cause actual events or results to differ
materially from those anticipated in the forward-looking statements
including, but not limited to delays or uncertainties with
regulatory approvals, including that of the CSE. There are
uncertainties inherent in forward-looking information, including
factors beyond the Company’s control. There are no assurances that
the business plans for AgraFlora Organics described in this news
release will come into effect on the terms or time frame described
herein. The Company undertakes no obligation to update
forward-looking information if circumstances or management's
estimates or opinions should change except as required by law. The
reader is cautioned not to place undue reliance on forward-looking
statements. Additional information identifying risks and
uncertainties that could affect financial results is contained in
the Company’s filings with Canadian securities regulators, which
are available at www.sedar.com.
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