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Tilray Medical Receives Italy’s First Authorization from the Ministry of Health to Distribute Medical Cannabis Flower for Therapeutic Use

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Tilray Medical (NASDAQ: TLRY), a division of Tilray Brands, has achieved a historic milestone by becoming the first company to receive authorization from Italy's Ministry of Health to import and distribute medical cannabis flower for therapeutic use. Through its subsidiary FL Group, the company will introduce three new medical cannabis varieties in Italy: Tilray THC 25%, Tilray THC 18%, and Tilray THC 9% / CBD 9%.

The products, which are EU-GMP certified, will be available through pharmacies across Italy starting June 2025. This expansion strengthens Tilray's European presence, where it already operates in Germany, Portugal, Poland, and the United Kingdom.

Tilray Medical (NASDAQ: TLRY), una divisione di Tilray Brands, ha raggiunto un traguardo storico diventando la prima azienda ad ottenere l'autorizzazione dal Ministero della Salute italiano per importare e distribuire infiorescenze di cannabis medica a scopo terapeutico. Attraverso la sua controllata FL Group, l'azienda introdurrà tre nuove varietà di cannabis medica in Italia: Tilray THC 25%, Tilray THC 18% e Tilray THC 9% / CBD 9%.

I prodotti, che sono certificati EU-GMP, saranno disponibili nelle farmacie italiane a partire da giugno 2025. Questa espansione rafforza la presenza di Tilray in Europa, dove è già attiva in Germania, Portogallo, Polonia e Regno Unito.

Tilray Medical (NASDAQ: TLRY), una división de Tilray Brands, ha alcanzado un hito histórico al convertirse en la primera empresa en recibir autorización del Ministerio de Salud de Italia para importar y distribuir flor de cannabis medicinal con fines terapéuticos. A través de su subsidiaria FL Group, la compañía introducirá tres nuevas variedades de cannabis medicinal en Italia: Tilray THC 25%, Tilray THC 18% y Tilray THC 9% / CBD 9%.

Los productos, que cuentan con la certificación EU-GMP, estarán disponibles en farmacias de toda Italia a partir de junio de 2025. Esta expansión fortalece la presencia de Tilray en Europa, donde ya opera en Alemania, Portugal, Polonia y Reino Unido.

틸레이 메디컬(NASDAQ: TLRY)은 틸레이 브랜드의 자회사로서 이탈리아 보건부로부터 치료용 의료용 대마초 꽃을 수입 및 유통할 수 있는 최초의 회사로 역사적인 승인을 받았습니다. 자회사 FL 그룹을 통해 이탈리아에 세 가지 새로운 의료용 대마초 품종을 선보일 예정입니다: Tilray THC 25%, Tilray THC 18%, Tilray THC 9% / CBD 9%.

이 제품들은 EU-GMP 인증을 받았으며, 2025년 6월부터 이탈리아 전역의 약국에서 구입할 수 있습니다. 이번 확장은 독일, 포르투갈, 폴란드, 영국 등 이미 진출한 유럽 시장에서 틸레이의 입지를 더욱 강화합니다.

Tilray Medical (NASDAQ : TLRY), une division de Tilray Brands, a franchi une étape historique en devenant la première entreprise à obtenir l'autorisation du Ministère de la Santé italien d'importer et de distribuer des fleurs de cannabis médical à usage thérapeutique. Via sa filiale FL Group, la société introduira trois nouvelles variétés de cannabis médical en Italie : Tilray THC 25 %, Tilray THC 18 % et Tilray THC 9 % / CBD 9 %.

Les produits, qui sont certifiés EU-GMP, seront disponibles dans les pharmacies à travers l'Italie à partir de juin 2025. Cette expansion renforce la présence de Tilray en Europe, où elle est déjà active en Allemagne, au Portugal, en Pologne et au Royaume-Uni.

Tilray Medical (NASDAQ: TLRY), eine Tochtergesellschaft von Tilray Brands, hat einen historischen Meilenstein erreicht, indem sie als erstes Unternehmen die Genehmigung des italienischen Gesundheitsministeriums erhalten hat, medizinisches Cannabisblüten zur therapeutischen Nutzung zu importieren und zu vertreiben. Über ihre Tochtergesellschaft FL Group wird das Unternehmen drei neue medizinische Cannabissorten in Italien einführen: Tilray THC 25%, Tilray THC 18% und Tilray THC 9% / CBD 9%.

Die Produkte, die EU-GMP-zertifiziert sind, werden ab Juni 2025 in Apotheken in ganz Italien erhältlich sein. Diese Expansion stärkt Tilrays Präsenz in Europa, wo das Unternehmen bereits in Deutschland, Portugal, Polen und dem Vereinigten Königreich tätig ist.

Positive
  • First company to receive Italian authorization for medical cannabis flower distribution
  • Introduction of three new medical cannabis products to Italian market
  • Expansion of European presence through regulatory approval
  • Access to Italy's pharmacy distribution network
Negative
  • None.

Insights

Tilray secures unprecedented Italian medical cannabis authorization, strengthening European leadership and opening new market opportunities.

Tilray's achievement in Italy represents a significant regulatory breakthrough in one of Europe's growing medical cannabis markets. As the first company authorized by Italy's Ministry of Health to import and distribute proprietary branded medical cannabis flower, Tilray gains first-mover advantage in a country where access to medical cannabis has been historically limited and bureaucratically challenging.

The immediate availability of three distinct cannabis formulations (THC 25%, THC 18%, and a balanced THC 9%/CBD 9%) demonstrates Tilray's strategic approach to serving diverse patient needs. These EU-GMP certified products provide Italian physicians with standardized, pharmaceutical-grade options that address various therapeutic applications.

This Italian authorization strengthens Tilray's European footprint, which now spans five key markets including Germany, Portugal, Poland, and the UK. The expansion aligns with Tilray's long-term strategy of establishing dominant positions in regulated medical markets before potential adult-use legalization.

Italy represents a meaningful opportunity within Tilray's international portfolio. With a population of approximately 60 million and growing physician acceptance of cannabis therapies, this regulatory milestone provides Tilray exclusive positioning that competitors will struggle to match in the near term. The ability to distribute through Italian pharmacies nationwide creates immediate market access that should translate to incremental revenue growth for Tilray's medical division.

SAVONA, Italy, June 24, 2025 (GLOBE NEWSWIRE) -- Tilray Medical (“Tilray”), a division of Tilray Brands, Inc. (NASDAQ: TLRY and TSX: TLRY) and a global leader in medicinal cannabis, empowering the therapeutic alliance between patients and healthcare practitioners to make informed individualized health decisions, today announced a significant milestone in its European expansion with the introduction of three new medical cannabis flower varieties in Italy. Through its wholly-owned subsidiary, FL Group, Tilray has become the first company in Italy to receive official authorization from the Ministero della Salute (Italian Ministry of Health) to import and distribute proprietary Tilray Medical-branded medical cannabis flower for therapeutic use.

Beginning this month, the following Tilray Medical products are approved for therapeutic use in Italy and available for distribution through pharmacies across Italy:

  • Tilray THC 25%
  • Tilray THC 18%
  • Tilray THC 9% / CBD 9%

Denise Faltischek, Chief Strategy Officer and Head of International at Tilray Brands, stated, “This milestone underscores the vital role of medical cannabis as a therapeutic medicine for patients in need, supporting their health and well-being. We are proud to expand our medical cannabis portfolio in Italy with the introduction of our Tilray Medical high-quality, EU-GMP certified medical cannabis products that uphold the highest standards in patient care. We extend our gratitude to the Ministero della Salute for their trust in Tilray Medical and for providing the necessary regulatory framework to ensure access to safe, consistent and reliable cannabinoid-based therapies. Together, we are advancing healthcare and patient wellness through innovation and collaboration.”

Tilray continues to lead the European medical cannabis market with operations in Germany, Italy, Portugal, Poland and the United Kingdom, offering a broad portfolio of EU-GMP certified medical cannabis products.

About Tilray Medical

Tilray Medical is dedicated to transforming lives and fostering dignity for patients in need through safe and reliable access to a global portfolio of medical cannabis brands, including Tilray Medical, Broken Coast, Redecan, Good Supply and Navcora. Tilray Medical grew from being one of the first companies to become an approved licensed producer of medical cannabis in Canada to building the first EU-GMP certified cannabis production facilities in Portugal and Germany. Today, Tilray Medical is a leading supplier of medical cannabis with a portfolio of brands and products designed to meet the needs of our patients worldwide.

For further information on Tilray Medical, visit Tilray Medical Europe, Tilray Medical Canada, and Tilray Medical Australia-New Zealand.

About Tilray Brands

Tilray Brands, Inc. (“Tilray”) (Nasdaq: TLRY; TSX: TLRY), is a leading global lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, New Zealand and Latin America that is leading as a transformative force at the nexus of cannabis, beverage, wellness, and entertainment, elevating lives through moments of connection. Tilray’s mission is to be a leading premium lifestyle company with a house of brands and innovative products that inspire joy and create memorable experiences. Tilray’s unprecedented platform supports over 40 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and craft beverages.

For more information on how we are elevating lives through moments of connection, visit Tilray.com and follow @Tilray on all social platforms.

Forward-Looking Statements

Certain statements in this communication that are not historical facts constitute forward-looking information or forward-looking statements (together, “forward-looking statements”) under Canadian securities laws and within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be subject to the “safe harbor” created by those sections and other applicable laws. Forward-looking statements can be identified by words such as “forecast,” “future,” “should,” “could,” “enable,” “potential,” “contemplate,” “believe,” “anticipate,” “estimate,” “plan,” “expect,” “intend,” “may,” “project,” “will,” “would” and the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Certain material factors, estimates, goals, projections, or assumptions were used in drawing the conclusions contained in the forward-looking statements throughout this communication. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, the Company’s ability to commercialize new and innovative products worldwide. Many factors could cause actual results, performance, or achievement to be materially different from any forward-looking statements, and other risks and uncertainties not presently known to the Company or that the Company deems immaterial could also cause actual results or events to differ materially from those expressed in the forward-looking statements contained herein. For a more detailed discussion of these risks and other factors, see the most recently filed annual information form of Tilray and the Annual Report on Form 10-K (and other periodic reports filed with the SEC) of Tilray made with the SEC and available on EDGAR. The forward-looking statements included in this communication are made as of the date of this communication and the Company does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events, or otherwise unless required by applicable securities laws.

For further information:
Media: news@tilray.com
Investor Relations: investors@tilray.com


FAQ

What authorization did Tilray (TLRY) receive from Italy's Ministry of Health in June 2025?

Tilray became the first company to receive authorization to import and distribute proprietary medical cannabis flower for therapeutic use in Italy through its subsidiary FL Group.

Which new medical cannabis products will Tilray (TLRY) introduce in Italy?

Tilray will introduce three new varieties: Tilray THC 25%, Tilray THC 18%, and Tilray THC 9% / CBD 9%, all available through Italian pharmacies.

Where does Tilray (TLRY) currently operate in Europe as of 2025?

Tilray operates in five European markets: Germany, Italy, Portugal, Poland, and the United Kingdom.

How will Tilray distribute its medical cannabis products in Italy?

Tilray will distribute its EU-GMP certified medical cannabis products through pharmacies across Italy.
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