TILRAY
1.2.2021 12:02:07 CET | Business Wire | Press release
Tilray, Inc. (NASDAQ: TLRY), a global pioneer in cannabis research, cultivation, production, and distribution, today announced that it has received the necessary approvals and market authorization in accordance with the Portuguese legislation to offer Tilray medical cannabis products in Portugal from its GMP-certified EU facility in Cantanhede, Portugal. The market authorization was issued by Infarmed, the Portuguese National Authority of Medicines and Health Products, whose rigorous process in providing such consent is internationally recognized.
This is the first time a full quality dossier was required and delivered to obtain market authorization in Europe for a medical cannabis product, and that process is now complete. Infarmed’s approval confirms the quality and safety standards of Tilray’s Good Manufacturing Processes (GMP) certified production.
According to Infarmed and Portuguese Medicinal Cannabis regulations, Tilray medical cannabis products are approved for the treatment of Spasticity associated with Multiple Sclerosis or spinal cord injuries; nausea, vomiting (resulting from chemotherapy, radiation therapy, and combined HIV medication for hepatitis C); appetite stimulation in the palliative care of patients undergoing oncological treatment or with HIV/AIDS; Tourette syndrome, Epilepsy, and treatment of severe seizure disorders in children; therapeutic-resistant Glaucoma and chronic pain (associated with oncological or nervous system diseases such as neuropathic pain injury caused by nerve damage, phantom limb pain, trigeminal neuralgia, or after herpes zoster).
Brendan Kennedy, Tilray’s Chief Executive Officer, said, "Tilray is committed to quality and patient safety, and we look forward to significantly improving the quality of lives of Portuguese patients through our medical cannabis products."
Sascha Mielcarek, Tilray's Managing Director in Europe, says, "We are very proud of Infarmed's market authorization, which confirms Tilray’s medical cannabis products live up to the highest national and international quality standards.” He continued, “ Patient demands are increasing in Portugal and throughout Europe, and our objectives are to provide them with the safest and best quality medical cannabis products. Patients can access Tilray products through major pharmaceutical distribution channels throughout Portugal and other European markets. We are confident that as demand increases around the world and more (regulated or authorized) medical cannabis markets emerge, Tilray’s EU campus is ready to serve more partners and patients across the EU and other international medical markets.”
In May 2020, Tilray received its third and complete Good Manufacturing Practice (GMP) certification for Tilray Portugal. The complete GMP-certification allows Tilray to manufacture medical cannabis extracts in-house and export GMP-produced finished medical cannabis products, both dried flower, and oil, from Portugal throughout the European Union and other international markets with authorized national medical cannabis programs. The certification also authorizes Tilray to manufacture bulk extracts on-site to sell as cannabis API (active pharmaceutical ingredients) and provides additional quality control lab capacity further to advance its ability for product innovation and research.
About Tilray®
Tilray is a global pioneer in the research, cultivation, production, and distribution of cannabis and cannabinoids, currently serving tens of thousands of patients and consumers in 16 countries spanning five continents.
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 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. 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 European 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 on November 9, 2020, for a discussion of the material risk factors that could cause actual results to differ materially from the forward-looking information. Tilray does not undertake to update any forward-looking statements that are included herein, except in accordance with applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210201005184/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
LUMI AI Factory Selects IQM to Deploy Advanced Quantum Computer, Accelerating Hybrid HPC and AI Development8.7.2026 14:00:00 CEST | Press release
The Halocene H4 quantum computer, named LUMI-IQ, will be delivered and installed in 2027 The system will be hosted at CSC – IT Center for Science in Finland and integrated into the LUMI AI Factory The system will provide researchers, industry innovators, and developers across Europe with a unique, advanced experimental platform where quantum computing and artificial intelligence converge The LUMI AI Factory, led by CSC – IT Center for Science, has selected IQM Quantum Computers (Nasdaq: IQMX) to deliver IQM Halocene H4, an advanced quantum computer aimed at accelerating hybrid high-performance computing, artificial intelligence, and quantum computing capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708006791/en/ LUMI AI Factory selects IQM to deploy advanced quantum computer, accelerating hybrid HPC and AI development IQM Halocene H4 is the first and most advanced on-premises superconducting quantum computer o
Merck Announces FDA Breakthrough Therapy Designation for Enpatoran in Lupus Patients With Active Skin Manifestations8.7.2026 14:00:00 CEST | Press release
Enpatoran could address a significant unmet need in lupus, specifically targeting cutaneous manifestations of the disease, which currently have no approved therapiesFDA's decision was supported by Phase 2 WILLOW study results, which demonstrated meaningful symptoms improvement, particularly among patients with active cutaneous manifestationsEnpatoran's potential to go beyond current treatment standards in lupus prompted FDA´s breakthrough designation, which is designed to expedite drug development and reviewNot intended for Canada-, UK- or US-based media Merck, a leading science and technology company, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to enpatoran for the treatment of lupus with active cutaneous manifestations. Enpatoran is an oral selective toll-like receptor (TLR) 7/8 inhibitor, designed to modulate pathways central to lupus-related inflammation. “For the 85% of lupus patients whose disease includes skin manif
Fastly Joins DIMPACT to Collaborate on Digital Sustainability8.7.2026 14:00:00 CEST | Press release
Fastly Brings Leading Cloud Edge Expertise to Help DIMPACT Members Understand and Optimize Digital Carbon Footprints Fastly, Inc. (NASDAQ: FSLY), a leading global edge cloud platform, today announced it has become a participant of DIMPACT, the coalition of leading organizations working to align industry changemakers and policymakers around meaningful, science-based solutions that reduce the environmental impacts of serving digital media products. As the first edge cloud platform provider to join the coalition, Fastly brings critical, real-world edge network data and infrastructure expertise and a transparent approach to emissions calculation and reporting to help major media, streaming, and publishing companies understand and optimize their digital carbon footprints. “We’re thrilled to welcome Fastly to the DIMPACT initiative. Their participation strengthens DIMPACT's ability to advance a more accurate, data-driven approach to measuring and reducing digital emissions,” said Jason Bell,
PubNub Introduces Blocks.ai: The Control Plane and Network Layer For AI Agents8.7.2026 14:00:00 CEST | Press release
Connect and control agents from everywhere, across any network and device, on the Blocks Network. PubNub introduces Blocks.ai today, a global network to connect and control agents across all agent frameworks, providers, and APIs. Blocks.ai lets developers reach their existing AI agents regardless of where they are hosted. Blocks Network supports all AI agent use cases without opening inbound ports, setting up tunnels, changing DNS, or modifying firewall rules. For more than a decade, PubNub has been the infrastructure and platform for real-time connectivity supporting billions of devices, now, PubNub delivers Blocks Network connecting the Internet of Agents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708521206/en/ AI agents have become increasingly critical to businesses who want control over their models, code, and data. But once those agents are running locally or behind a firewall, making them reachable from custom
STEMCELL Technologies and CCRM Partner to Expand Access to Matched GMP and RUO iPSC Lines for Cell Therapy Development8.7.2026 14:00:00 CEST | Press release
Partnership pairs GMP-manufactured iPSC lines with matched RUO equivalents, giving developers well-characterized, donor-eligible starting materials from early research through clinical development. Supporting comparability data for the RUO and GMP lines to be presented at the 2026 ISSCR Annual Meeting in Montréal, Canada. STEMCELL Technologies and the Centre for Commercialization of Regenerative Medicine (CCRM) today announced a partnership to expand access to high-quality human induced pluripotent stem cell (iPSC) starting materials, giving cell therapy developers worldwide a faster, lower-risk path from research to the clinic. Under the agreement, STEMCELL will manufacture and distribute research-use-only (RUO) iPSC lines derived directly from LineaBio's Good Manufacturing Practices (GMP) iPSC lines, and will offer the matched GMP lines to developers worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708212795/en
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
