Business Wire

Tilray® Receives the First and Only Market Authorization to Offer Medical Cannabis Products in Portugal

1.2.2021 14:00:00 EET | Business Wire | Press release

Share

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

For further information:
Tilray Global:
Berrin Noorata
news@tilray.com

To request an interview opportunity:
Media
Ranjit Dhatt
647-890-2445
ranjit@pomppr.com

Investors
Raphael Gross
203-682-8253
Raphael.Gross@icrinc.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)3.9.2026 23:30:00 EEST | Press release

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to thirty-one newly hired non-executive employees. The equity awards were granted on September 1, 2026 and consisted of options to purchase an aggregate of 280,600 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 133,500 shares. The options have an exercise price per share equal to $13.24, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restr

Mainstay Medical Announces Two-Year Outcomes from RESTORE Clinical Trial of ReActiv8®3.9.2026 23:30:00 EEST | Press release

Mainstay Medical Holdings plc today announced the publication of the two-year assessment results from the RESTORE randomized clinical trial of ReActiv8 for the treatment of intractable chronic low back pain. The data show continued improvements in back pain-related disability, pain and quality of life in the ReActiv8 treatment group, and improvements after one year of ReActiv8 therapy in the crossover group that were indistinguishable from the improvements shown by the treatment group at their one-year assessment. The results were published in The Spine Journal, and the article is available free of charge here: https://doi.org/10.1016/j.spinee.2026.07.006. The study included 203 patients, with 99 randomized into the treatment arm and 104 randomized into the control arm. Patient-reported outcomes were collected at regular intervals to the one-year primary endpoint assessment, at which time the patients in the control arm were offered implantation with the ReActiv8 system. Eighty-three p

Lenovo Advances Hybrid AI Across New Personal and Enterprise Technology3.9.2026 19:00:00 EEST | Press release

Today at Lenovo™ Innovation World during IFA 2026, Lenovo unveiled a new portfolio of personal and enterprise technology, showing how its Hybrid AI strategy is moving from vision to practical experiences across devices, infrastructure, services, and the everyday moments that connect them. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260903555953/en/ Lenovo Innovation World at IFA 2026 The announcements bring together Lenovo’s “one personal AI, multiple devices” approach with enterprise technology that helps organizations turn data into insights and value. They span personal AI across PCs, smartphones, tablets, and wearables; creator and consumer devices that adapt to different ways of working and expressing ideas; and business technology built for AI-enabled productivity, collaboration, security, and scale. Lenovo also demonstrated how design and form factor remain central to making technology more useful: from high-perfor

Kaltura and Verimatrix Partner to Strengthen Security for OTT and Cloud TV Services3.9.2026 18:45:00 EEST | Press release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260903384589/en/ Kaltura (Nasdaq: KLTR), the Agentic Digital Experience company, and Verimatrix (Euronext Paris: VMX), a leading provider of security solutions for a safer connected world, today announced a strategic partnership designed to provide enhanced protection for OTT and Cloud TV services. The partnership brings together Kaltura's scalable Cloud TV platform and Verimatrix's Digital Rights Management (DRM) and security capabilities. The joint solution, as part of Kaltura’s Marketplace, helps Telco’s, broadcasters, and media companies securely deliver premium live and on-demand content across a wide range of devices and operating systems. Demand for advanced content protection has grown, and Kaltura's Cloud TV footprint has expanded across Telco’s, operators, broadcasters, and media companies. Partnering with Verimatrix, a recognized leader in content pro

Bahrain Signs its Participation Contract for Expo 2030 Riyadh3.9.2026 18:45:00 EEST | Press release

The Kingdom of Bahrain has signed its Participation Contract for Expo 2030 Riyadh, marking a new phase in preparations for its participation in the World Expo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260903144412/en/ His Excellency Sheikh Khalifa bin Ahmed Al Khalifa, President of the Bahrain Authority for Culture and Antiquities, and Talal Al-Marri, Chief Executive Officer of Expo 2030 Riyadh, at the ceremony. The agreement provides the formal framework for Bahrain’s participation in Expo 2030 Riyadh, enabling preparations to advance across the key organizational and operational aspects of its presence throughout the six-month event, including the development of its pavilion, programmes and visitor experiences. The Participation Contract was signed in Bahrain by Talal Al-Marri, Chief Executive Officer of Expo 2030 Riyadh, on behalf of Expo 2030 Riyadh, and His Excellency Sheikh Khalifa bin Ahmed Al Khalifa, President

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye