European Expectations - and RealityZena has not sold a single gram of recreational cannabis in Europe - they can't sell diect because they don't have a SALES LICENCE. and neither does Farmako - their partner (whom they repeatdley tout a 500 gram/year deal since 2019)
European Union (“EU”) Export Update
In February 2020, Zenabis received an export license from Health Canada to export cannabis to the EU. With this export license, Zenabis intends to supply pharmaceutical-grade cannabis products to the EU market.
Subject to obtaining the requisite regulatory approvals, Zenabis expects the initial test shipment to its EU partner to occur in March of 2020 and to commence shipping bulk product into the EU market in Q2 2020.
Zenabis Obtains EU-GMP Approval to Supply Medical Cannabis to Europe and Amendments to Health Canada License
Vancouver, British Columbia – May 20, 2020 – Zenabis Global Inc. (TSX:ZENA) (“Zenabis” or the “Company”) is pleased to announce that it has successfully received EU-GMP approval for its Atholville facility and expects to commence commercial export to the European Union in the third quarter of 2020. In addition, the Company is announcing Health Canada approval of additional growing and processing areas at Zenabis Langley.
Kevin Coft, Chief Executive Officer of Zenabis stated, “We are very excited to be able to announce that Zenabis, in conjunction with our European Union partners Natrix Sciences Ltd. (formerly Starpharma Ltd. Malta) and ZenPharm Ltd., have received EU-GMP approval. This is a tremendous milestone for the Company as it will allow us to supply bulk dried medicinal cannabis to the European market and allow ZenPharm the supply needed to serve their customers throughout Europe. I would like to extend my thanks to the entire Zenabis team who have made this major achievement possible as well as to our European partners for their continued support in this process. With our extremely competitive cost of cultivation at $0.63 per gram in the first quarter of 2020, we believe we can be incredibly competitive in the export of cannabis to the European Union.”
Receipt of EU-GMP Approval
Zenabis Global Inc. has obtained EU-GMP approval through its Malta-based European partner, ZenPharm Limited. This milestone enables Zenabis to supply the European market with bulk dried medicinal cannabis flower through its ZenPharm joint venture. Zenabis is a 43.5% owner of ZenPharm. ZenPharm is located within an existing EU-GMP facility in Europe managed by the other 43.5% owner of ZenPharm, Natrix Sciences Limited Malta (“Natrix”). ZenPharma is regulated by the Maltese ‘Production of Cannabis for Medicinal and Research Purposes Act’, which allows for the cultivation, import, processing, and production of cannabis intended for medicinal and research purposes. Zenabis’ EU-GMP approval provides ZenPharm with an approved supplier which will allow it to undertake the necessary regulatory requirements in order to achieve its own GMP certification for the packaging and processing of cannabis from the Maltese Medicines Authority. The approval came after an intense 4-day inspection of the facility, which provided ZenPharm with confidence in the Zenabis GMP Quality Management Systems (“QMS”) and products.
enabis Announces Term Sheet for the Supply of Medical Cannabis to the German Market and Receipt of a License Amendment for Zenabis Stellarton
Vancouver, British Columbia – June 5, 2020 – Zenabis Global Inc. (TSX:ZENA) (“Zenabis” or the “Company”) is pleased to announce that it has assigned its binding term sheet with Farmako GmbH (“Farmako”) to its subsidiary company ZenPharm for the supply of European Union Good Manufacturing Practices (“EU GMP”) certified medicinal cannabis and amended the terms to provide for a minimum volume guarantee. The Company is also pleased to announce the receipt of its sales license amendment for Zenabis Stellarton from Health Canada.
Medicinal Cannabis Supply to Germany - Zenabis has assigned its term sheet with Farmako, which was announced on April 29, 2019, to its Maltese-based European joint venture, ZenPharm.
- ZenPharm is expected to process EU GMP compliant bulk from Zenabis to supply Farmako with a minimum of 500 kg per year for a term of three years.
- This is subject to ZenPharm itself obtaining EU GMP certification, which is expected to occur in Q3, 2020.
- ZenPharm
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- As previously announced on June 5, 2020, the Company assigned its binding term sheet with Farmako GmbH (“Farmako”) to its subsidiary ZenPharm for the supply of European Union Good Manufacturing Practices (“EU GMP”) certified medicinal cannabis and amended the terms of the terms sheet to provide for a minimum volume guarantee. Under this terms sheet, ZenPharm is expected to process a minimum of 500 kg per year of EU GMP compliant bulk cannabis following ZenPharm receiving EU GMP certification, which is expected to occur in Q3 2020. Shipments to Farmako from ZenPharm are expected to commence in Q3 2020, and ZenPharm anticipates supplying cannabis oils to Farmako beginning in 2021. ZenPharm will be supplied solely from Zenabis Atholville.
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- Vancouver, British Columbia, February 1, 2021 – Zenabis Global Inc. (TSX:ZENA) ("Zenabis" or the "Company") announces today that its Maltese joint venture, ZenPharm Limited (“ZenPharm”), has received European Union Good Manufacturing Practices (“EU GMP”) certification issued by the Malta Medicines Authority.
- EU GMP certification is issued by the designated regulatory authority to pharmaceutical facilities that have passed a rigorous regulator-led audit and inspection process. EU GMP certification is a requirement for export of medicinal cannabis products into most European markets and ensures that patients seeking medicinal cannabis treatments benefit from the highest quality and safety standards in manufacturing processes.
- ZenPharm will commence shipments of dried cannabis produced by Zenabis’ EU GMP compliant approved facility in Atholville, New Brunswick into the EU medicinal cannabis market upon receipt of its final license requirement issued by the Malta Medicines Authority for the Production of Cannabis for Medicinal and Research Purposes (“Cannabis License”) as afforded under Chapter 578 of the laws of Malta, which is expected to occur in the first quarter of 2021. ZenPharm’s has already signed its first supply agreement with a customer located in Germany with minimum volume commitments of 500 kg per year.
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- Vancouver, British Columbia, May 14, 2021 – Zenabis Global Inc. (TSX: ZENA) (“Zenabis” or the “Company”) announces today that its Maltese joint venture, ZenPharm Limited (“ZenPharm”), has received its Licence for the Production of Cannabis for Medicinal and Research Purposes (“Medicinal Cannabis License”) issued by the Malta Medicines Authority, as afforded under Chapter 578 of the laws of Malta.
- The receipt of the Medicinal Cannabis License follows on the earlier European Union Good Manufacturing Practices (“EU GMP”) certification issued by Malta Medicines Authority in January 2021.
- The Medicinal Cannabis License is the final license requirement under Malta’s regulatory framework allowing for commercial bulk imports into Malta from Zenabis’ facility in Atholville and subsequent exports of finished medicinal cannabis products to countries of the European Union and United Kingdom. After closing of the Arrangement plan, HEXO (TSX: HEXO; NYSE: HEXO) and Zenabis’ combined product portfolio are expected to gain access to the European market.
- The Medicinal Cannabis License allows ZenPharm to commence commercial shipments to the European Union, where Germany is ZenPharm’s most prominent target market. ZenPharm has an executed supply agreement with a German-based customer to supply a minimum volume of 500 kg per year. To that end, ZenPharm will be accepting shipments of up to 300kg from Zenabis Atholville through the end of this calendar year.
- ZenPharm will also be launching finished cannabis products under its own brand for distribution within the Maltese medicinal cannabis market, with similar entry into the Polish Market expected in the Q1 2022.