Tilray Inc. (TLRY:NASDAQ), a global pioneer in cannabis cultivation, processing and distribution, today announced that it has successfully imported Good Manufacturing Practices (GMP)-certified finished medical cannabis oral solutions into Ireland intended for nationwide distribution.
“As we continue our expansion in Europe and around the world, it’s encouraging to see regulators’ commitment to quality and safety. We look forward to supplying patients in Ireland with our full offering of pharmaceutical-grade medical cannabis products as regulations allow.”
On June 26, 2019, Ireland’s Department of Health enacted the Medical Cannabis Access Programme, which provides compassionate access to medical cannabis for patients in need in Ireland. This new program provides an alternative to legislation that only allows access by patients with a ministerial license, marking a significant milestone for Ireland and the global medical cannabis industry. The Medical Cannabis Access Programme is expected to allow patients to access Tilray oral solutions in the second half of this year. Patients suffering from indications not covered by the program will still have the option to obtain a ministerial license for such products.
“This development in Ireland represents an exciting turning point for patients,” says Catherine Jacobson, Tilray’s Vice President of Medical and Regulatory Affairs. “We’re proud to have the opportunity to provide patients in Ireland with access to Tilray’s standardized GMP-certified medical cannabis products, and we’re thrilled to see an increasing number of countries improve access to medical cannabis. We will continue to do our part to increase access for patients in need around the world.”
The Tilray products successfully imported will be made available to qualified patients through the Access Programme once distribution approvals are provided by local regulators. This will allow patients in Ireland access to a locally maintained supply of GMP-certified products, which they can receive in a reasonable time-frame. Authorized patients are expected to be able to access Tilray medical cannabis products through the Irish community pharmacy network in the second half of the year.
“We’re proud to celebrate the milestone of Ireland becoming the 13th country to receive Tilray products,” says Sascha Mielcarek, Tilray’s Managing Director, Europe. “As we continue our expansion in Europe and around the world, it’s encouraging to see regulators’ commitment to quality and safety. We look forward to supplying patients in Ireland with our full offering of pharmaceutical-grade medical cannabis products as regulations allow.”
The products imported into Ireland are GMP-manufactured oral solutions containing tetrahydrocannabinol (THC) and cannabidiol (CBD). Such products will be used to treat approved indications in Ireland, as regulations allow. Tilray intends to supply Irish patients with its full suite of medical cannabis products when authorized by the country’s Department of Health.
Tilray is a global pioneer in cannabis cultivation, processing and distribution currently serving tens of thousands of patients in 13 countries spanning five continents.
Cautionary note regarding forward-looking statements:
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements or forward-looking-information in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions, including without limitation statements in respect to Tilray’s intention to make products available in new or existing markets. Forward-looking statements are not a guarantee of future performance and are based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment and future approvals and permits. Actual results, performance or achievement could differ materially from that expressed in, or implied by, any forward-looking statements in this press release, and, accordingly, you should not place undue reliance on any such forward-looking statements and they are not guarantees of future results. Please see the heading “Risk Factors” in Tilray’s Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission and Canadian securities regulators on May 15, 2019, assumptions, uncertainties and other factors that may cause actual future results or anticipated events to differ materially from those expressed or implied in any forward-looking statements. Tilray does not undertake and specifically declines any obligation to update any forward-looking statements that are included herein, except in accordance with applicable securities laws.