Tilray® Receives the First and Only Market Authorization to Offer Medical Cannabis Products in Portugal
February 01 2021 - 6:00AM
Business Wire
With new market authorization, Tilray confirms its
development in the international medical cannabis sector and its
leadership position in the EMEA region
Portugal will become the 16th country where patients can
access Tilray medical cannabis products
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210201005184/en/
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
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