Tilray Becomes North America’s First GMP Certified Medical Cannabis Producer

Tilray, a global leader in medical cannabis research and production, today announced that it has become the first medical cannabis producer in North America to be GMP certified in accordance with the European Medicines Agency’s (EMA) Good Manufacturing Practice (GMP) standards. As North America’s only GMP certified medical cannabis producer, Tilray is uniquely positioned to expand distribution of its pharmaceutical-grade medical cannabis products to patients, physicians, pharmacies, hospitals and researchers in new markets around the world.

“GMP certification is the most rigorous standard that manufacturers of medical products must meet in their production processes, and it provides regulators and health care providers in countries new to medical cannabis with certainty that Tilray products are the safe and smart choice,” said Dr. Joshua Eades, Tilray’s Chief Science Officer.

As an internationally recognized standard, GMP is designed to ensure that medicines are consistently produced and controlled with the highest levels of quality and purity. Tilray is currently the only medical cannabis producer in North America to have a certificate of GMP compliance published in the European Union’s GMP database (EudraGMDP Certificate No: SUKLS34175/2016). The certificate was issued following a rigorous inspection by the Czech Republic’s State Institute for Drug Control (SUKL).

GMP certification enables Tilray to expand distribution of its products, including whole flower, oils or capsules, to new markets around the world. In 2016, Tilray became the first company to legally export medical cannabis products from North America to Australia and the European Union. In 2017, the company plans to expand distribution of its products to additional countries, including Germany which recently legalised medical cannabis.

GMP certification also allows Tilray to continue to break new ground in clinical research, advancing the science, safety and efficacy of medical cannabis for patients with a diverse range of conditions. Tilray currently supplies pharmaceutical-grade medical cannabis products for three different clinical trials in partnership with world-leading hospitals and universities:

• The first trial is being conducted in partnership with the University of British Columbia to examine the safety and tolerability of medical cannabis for Canadian military veterans and other patients suffering from PTSD.
• The second trial is being conducted in partnership with the University of Sydney, Chris O’Brien Lifehouse and the New South Wales government to study the safety, tolerability and efficacy of cannabinoids for chemotherapy-induced nausea and vomiting.
• The third trial is examining safety and tolerability of cannabinoids in children with Dravet Syndrome (a severe form of treatment-resistant epilepsy) at Toronto’s Hospital for Sick Children.
• Tilray plans to announce additional research partnerships in the coming year.

About Tilray

Tilray is a global leader in medical cannabis research and production dedicated to advancing the science, safety, and efficacy of medical cannabis. The company operates one of the largest and most sophisticated federally licensed medical cannabis cultivation facilities in the world, offering a range of products to patients, pharmacies and researchers in Australia, Canada, the European Union and the Americas.

Tilray Announces Medical Cannabis Export to New Zealand

Tilray, a global leader in medical cannabis research and production, today announced that it has received necessary approvals in Canada and New Zealand to export medical cannabis to New Zealand.

“We are proud to be able to offer patients in need access to high-quality, pharmaceutical-grade medical cannabis products,” said Brendan Kennedy, Tilray President.

Tilray will supply Middlemore Hospital in Auckland with precisely formulated medical cannabis oil containing tetrahydrocannabinol (THC) and cannabidiol (CBD). New Zealand law permits patients to access medical cannabis products with special authorization from the Ministry of Health. The first shipment of Tilray products is expected to arrive in Auckland by the end of February.

Tilray currently supplies pharmaceutical-grade medical cannabis products – including whole flower, oils and capsules – to thousands of patients, physicians, pharmacies, hospitals, governments and researchers around the world for commercial, compassionate access and research purposes.

Tilray became the first medical cannabis producer in North America to be certified in accordance with the European Medicines Agency’s (EMA) Good Manufacturing Practice (GMP) standards in December 2016. GMP certification is the most rigorous standard that manufacturers of medical products must meet in their production processes, and it provides regulators and health care providers in countries new to medical cannabis with certainty that Tilray products are the safe and smart choice.

GMP certification is enabling Tilray to expand international distribution of its products for commercial, clinical research and compassionate purposes. In 2016, Tilray made history by becoming the first company to legally export medical cannabis products from North America to Australia and the European Union. In 2017, the company is focused on expanding distribution of its products to additional countries in Europe and Latin America. The company is currently partnering with hospitals and universities on three clinical trials focused on pediatric epilepsy, post-traumatic stress disorder (PTSD), and chemotherapy-induced nausea and vomiting (CINV).

Tilray is a global leader in medical cannabis research and production dedicated to advancing the science, safety, and efficacy of medical cannabis. The company operates one of the largest and most sophisticated federally licensed medical cannabis cultivation facilities in the world, offering a range of products to patients, physicians, pharmacies, governments, hospitals and researchers in Australia, Canada, the European Union, New Zealand and Latin America.

Tilray Exports Medical Cannabis to Australia

Tilray, a GMP-certified global leader in medical cannabis research and production, today announced that it has successfully exported medical cannabis products to the state of Victoria in Australia.

According to the government of Victoria, 29 critically ill children will become the first patients in the Australian state to legally access medical cannabis when the Tilray products are distributed. Tilray products are currently available to certain patients in other Australian states and in New Zealand under special access pathways for unapproved medicines.

“This is too important to wait. That’s why we’re doing everything we can to make sure those families in the greatest need can access this life-changing treatment for their kids as soon as possible,” said Premier Daniel Andrews of Victoria, Australia. “This is the first time in Victoria kids with severe epilepsy will be able to legally access medicinal cannabis.”

“We know this medicine can dramatically change the quality of life for some of Victoria’s very sick kids,” said Victoria Minister for Health Jill Hennessy. “This means families will no longer have to make the heart-breaking choice between breaking the law or watching their kids suffer.”

“We are proud to be able to offer patients in need access to high-quality, pharmaceutical-grade medical cannabis products,” said Dr. Catherine Jacobson, Tilray director of clinical research. “In this case, the government of Victoria has elected to fast-track the introduction of a medical cannabis product containing a specific cannabinoid, cannabidiol (CBD), for the treatment of seizures in children who have not responded to formally approved anti-seizure drugs. We welcome the opportunity to provide this potentially life-saving treatment to patients in need.”

Tilray currently supplies pharmaceutical-grade medical cannabis products – including whole flower, oils and capsules – to thousands of patients, physicians, pharmacies, hospitals, governments and researchers around the world for commercial, compassionate access and research purposes.

Tilray became the first medical cannabis producer in North America to be certified in accordance with the European Medicines Agency’s (EMA) Good Manufacturing Practice (GMP) standards in December 2016. GMP certification is the most rigorous standard that manufacturers of pharmaceutical products must meet in their production processes, and it provides regulators and health care providers in countries new to medical cannabis with certainty that Tilray products are the safe and smart choice.

GMP certification is enabling Tilray to expand international distribution of its products for commercial, clinical research and compassionate purposes. In 2016, Tilray made history by becoming the first company to legally export medical cannabis products from North America to Australia and the European Union. In 2017, the company is focused on expanding distribution of its products to additional countries in Europe and Latin America.

Tilray is committed to advancing the science and safety of medical cannabis products by supporting clinical research. The company is currently partnering with hospitals and universities to supply three clinical trials focused on pediatric epilepsy at Toronto SickKids Hospital in Canada, post-traumatic stress disorder at the University of British Columbia in Canada, and chemotherapy-induced nausea and vomiting at the University of Sydney in Australia.

Tilray is a GMP-certified global leader in medical cannabis research and production dedicated to advancing the science, safety, and efficacy of medical cannabis. The company operates one of the largest and most sophisticated federally licensed medical cannabis cultivation facilities in the world, offering a range of products to patients, physicians, pharmacies, governments, hospitals and researchers in Australia, Canada, the European Union, New Zealand and Latin America.

Tilray Completes First Bulk Medical Cannabis Export to Australia Under New Regulations

Tilray, a global leader in medical cannabis research and production, today announced it has completed its first import of medical cannabis products into Australia under the country’s new import regulations. The products were produced at Tilray’s federally licensed, GMP-certified facility in Canada and can be dispensed to any patient with a valid prescription.

“We are proud to be able to offer Australian patients in need access to high quality, pharmaceutical-grade medical cannabis products in accordance with quality standards mandated by the Australian government,” said Brendan Kennedy, Tilray President. “We commend the Australian government on its recent steps to legalize and regulate medical cannabis as well as to ensure patient access.”

With the bulk shipment of Tilray products now warehoused in Australia, Tilray can serve patients as soon as they become authorized to receive medical cannabis under Australian regulations. Importing in bulk reduces costs and ensures Tilray can provide products faster to patients in need. Tilray is currently providing oils containing tetrahydrocannabinol (THC) and/or cannabidiol (CBD) in Australia. The company plans to introduce capsules containing THC and/or CBD in the coming months.

Earlier this year, Tilray announced that it had successfully exported medical cannabis products to the state of Victoria for 29 children with severe epilepsy, who became the first patients in the state to legally access medical cannabis. Currently, Tilray is able to supply medical cannabis products to authorized patients in every Australian state and territory. Tilray also serves authorized patients in New Zealand, North America, Latin America, and the European Union.

Tilray became the first medical cannabis producer in North America to be GMP certified in December 2016. GMP certification is the most rigorous standard that manufacturers of medical products must meet in their production processes, and it provides regulators and health care providers in countries new to medical cannabis with certainty that Tilray products are the safe and smart choice.

GMP certification is enabling Tilray to expand international distribution of its products for commercial, clinical research, and compassionate access purposes. In 2016, Tilray made history by becoming the first company to legally export medical cannabis products from North America to Australia and the European Union.

Tilray is also committed to advancing the science and safety of medical cannabis products by supporting clinical research. In Australia, Tilray has partnered with the University of Sydney and New South Wales Government to study medical cannabis as a treatment for symptoms of chemotherapy-induced nausea and vomiting. Tilray supports additional clinical trials focused on pediatric epilepsy at SickKids Hospital in Canada and post-traumatic stress disorder at the University of British Columbia in Canada.

About Tilray

Tilray is a GMP-certified global leader in medical cannabis research and production dedicated to advancing the science, safety, and efficacy of medical cannabis. The company operates one of the largest and most sophisticated federally licensed medical cannabis cultivation facilities in the world, offering a range of products to patients, physicians, pharmacies, governments, hospitals and researchers in Australia, Canada, the European Union, New Zealand and Latin America.