Aleafia Health’s indirect subsidiary, Emblem Germany GmbH, has formally submitted its application to German regulators for EU Good Manufacturing Practices (EU-GMP) certification.
The Company’s newly licensed Paris Facility has been purpose built to meet EU-GMP certification requirements, pharmaceutical-grade production’s highest standard, and as a result, provides wide access to global markets. The application, if successful, would allow the Company’s Paris Facility to produce and export EU-GMP certified cannabis products to the European Union.
Cannabis production operations commenced on May 6, 2020 at the Paris Facility Phase II expansion, only three business days following receipt of the amended Health Canada license.
Aleafia Health indirectly owns 60 percent of Emblem Germany, by way of a joint-venture between Emblem and German pharmaceutical wholesaler and logistics company, Acnos Pharma GmbH. It is difficult to ascertain the timeline for securing certification, but the Company intends to continue preparing for an eventual facility inspection.
Aleafia Health and Acnos’ senior management are directing the effort and have previously led the build-out, certification and operation of multiple EU-GMP certified pharmaceutical production facilities in The Netherlands, Germany and North America.
Later this month, Acnos is expected to complete a new pharmaceutical production and supply chain facility in Aachen Brand, Germany. It contains a dedicated cannabis distribution hub that Acnos owns and Emblem Germany will operate, allowing the Company to commence sales upon receipt of necessary German export and import permits.
“The state-of-art expansion of the Paris Facility, purpose built to meet EU-GMP standards, creates a unique competitive advantage with significant barriers to entry,” said Aleafia Health CEO Geoffrey Benic. “We look forward to leveraging the skillsets of our strong partner Acnos Pharma along with our management team’s in-house EU-GMP expertise.”
“The near completion of our international cannabis distribution center along with Emblem’s Paris Facility Phase II expansion licence are breakthrough milestones toward our goal to achieve a EU-GMP Licence and receiving Emblem-produced cannabis oil products in Germany," said Maximillian Claudel, Acnos Co-Owner and Managing Director, Emblem Germany.