MediPharm Labs Achieves Critical European Regulatory Milestone Supporting Commercialization of Proprietary Metered-Dose Cannabis Inhaler Platform

Positive Article 117 Notified Body Opinion satisfies a key EU regulatory requirement for an advanced cannabis drug-device combination product and supports planned commercialization in the UK and Europe

TORONTO, Nov. 05, 2026 (GLOBE NEWSWIRE) -- MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF) (FSE: MLZ) (“MediPharm”, “MediPharm Labs” or the “Company”), a pharmaceutical company specialized in precision-based cannabinoids, today announced that it has received a positive Notified Body Opinion from BSI Group, The Netherlands B.V. (Notified Body 2797).

For medicinal products that incorporate a device as a single integral product, an Article 117 Notified Body Opinion is a key regulatory requirement supporting commercialization in the European Union. The review provided independent confirmation that the device component meets applicable safety, performance, design and information requirements. This positive opinion supports a broader regulatory and commercial pathway for MediPharm to introduce the platform as an unlicensed medicinal cannabis product in the United Kingdom and selected European markets in 2027, subject to country-specific requirements, including regulatory acceptance and import permits.

The milestone positions MediPharm to advance the commercialization of its licensed, proprietary inhalation technology platform through Blackpoint Limited (“Blackpoint”). MediPharm is the exclusive global manufacturer and licensee of the technology under a 2024 licensing agreement with Remidose Aerosols Inc. (“Remidose”). Remidose supported the application process, and Blackpoint will lead commercialization and distribution activities for the Blackpoint-branded products across the United Kingdom and Europe.

“This is an important regulatory milestone for our inhaler and an important step toward commercialization in the United Kingdom and Europe. The positive Article 117 opinion provides independent confirmation that the device constituent meets applicable EU safety and performance requirements and further strengthens the foundation for bringing this innovative cannabinoid delivery platform to patients. We believe there is growing interest in cannabinoid medicines that offer precise, consistent dosing and a familiar pharmaceutical delivery format, and our inhaler is designed to address those needs,” said Greg Hunter, Chief Executive Officer of MediPharm Labs.

MediPharm Labs first launched metered-dose inhaler products in Canada under the MediPharm Labs brand, with a portfolio of THC, CBD, CBN and CBG formats available in select provinces and via direct-to-patient medical platforms, prior to expanding the inhaler to Australia, where products are available under the Beacon Medical brand and through a white-label partnership. The initial product portfolio for the EU currently includes THC 2.5 mg, THC 5 mg and balanced THC 2.5 mg:CBD 2.5 mg metered-dose inhaler products. The platform is designed to deliver a consistent, reproducible and metered cannabinoid dose with each actuation through a compact, discreet and portable inhaler.

The positive opinion comes as the European medicinal cannabis market continues to expand. Prohibition Partners’ estimates translate to approximately C$2.1 billion in European medicinal cannabis sales in 2025 and approximately C$3.5 billion in 2027. Germany and the United Kingdom together represented roughly 85% of estimated European sales in 2025, aligning the platform with the region’s two largest commercial markets. ¹

Unlike conventional smoked or vaporized cannabis formats, the MediPharm metered-dose inhaler provides smoke-free administration through a familiar pharmaceutical delivery format. Its metered-dose design is intended to support more precise and repeatable dosing, while its compact design provides patients with a convenient, discreet and portable option. For prescribers, the standardized API-based formulations and defined dose per actuation are intended to support greater confidence in dose delivery and treatment consistency.

MediPharm believes metered-dose inhalation represents an important evolution in cannabinoid therapeutics by combining rapid inhaled delivery with precision-controlled dosing and pharmaceutical manufacturing standards.

“The successful completion of the Notified Body review represents a significant milestone for Blackpoint and MediPharm and lays the groundwork for bringing a highly differentiated cannabinoid product platform to patients across Europe,” said David Martinez, Chief Executive Officer of Blackpoint. “We believe there is a growing need for cannabinoid products that combine pharmaceutical quality, predictable dosing and ease of use. We look forward to continuing our work with MediPharm as we prepare for commercial availability.”

About MediPharm Labs

Founded in 2015, MediPharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research-driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities for delivery of pure, trusted and precision-dosed cannabis products for its customers. MediPharm Labs develops, formulates, processes, packages and distributes cannabis and advanced cannabinoid-based products to domestic and international medical markets.

In 2021, MediPharm Labs received a Pharmaceutical Drug Establishment Licence from Health Canada, becoming the only company in North America to hold a commercial-scale domestic Good Manufacturing Practices Licence for the extraction of multiple natural cannabinoids. This GMP licence was the first step in the Company’s current foreign drug manufacturing site registration with the U.S. FDA. MediPharm also has EU-GMP certification, ANVISA GMP certification from Brazil and TGA compliance in Australia.

In 2023, MediPharm acquired VIVO Cannabis Inc., which expanded MediPharm’s reach to medical patients in Canada through the Canna Farms medical e-commerce platform and in Australia and Germany through Beacon Medical Pty. Ltd. and Beacon Medical GmbH. The acquisition also included Harvest Medical Clinics in Canada, which provides medical cannabis patients with physician consultations, education and prescriptions.

The Company carries out its operations in compliance with all applicable laws in the countries in which it operates.

Website: www.medipharmlabs.com

About Blackpoint

Founded in 2021, Blackpoint Biotech is a company specialized in the delivery of cannabinoid-based metered-dose inhalers.

Blackpoint is MediPharm Labs’ exclusive sales and distribution partner in the United Kingdom and Europe, where it markets MediPharm’s metered-dose inhaler platform under the Blackpoint brand.

For further information, please contact:

MediPharm Labs Investor Relations
1-416-913-7425
investors@medipharmlabs.com

Cautionary Note Regarding Forward-Looking Information

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, the significance of the positive Article 117 Notified Body Opinion and its role in supporting the regulatory and commercial pathway for MediPharm’s pMDI platform; the planned commercialization of the platform in the United Kingdom and selected European markets, including as an unlicensed medicinal cannabis product; the satisfaction of country-specific regulatory, import, prescribing and distribution requirements; Blackpoint’s commercialization and distribution of the Blackpoint-branded products; MediPharm’s ability to manufacture and supply the products; the expected benefits, differentiation and market acceptance of the platform among patients and prescribers; demand for pharmaceutical-quality cannabinoid medicines; and estimates of the size and growth of the European medical cannabis market. The material assumptions underlying these forward-looking statements include, but are not limited to, the continued availability of the regulatory pathways described in this news release, the ability of MediPharm and Blackpoint to obtain required country-specific authorizations, the continuation of the Company’s commercial and licensing relationships, and the Company’s ability to manufacture and supply products in accordance with applicable GMP requirements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm to obtain adequate financing; the delay or failure to receive regulatory approvals; the inability of MediPharm or Blackpoint to obtain or maintain required licences, registrations, permits, import authorizations or other regulatory clearances; changes in the regulatory treatment of drug-device combination products or unlicensed medicinal cannabis products in the United Kingdom or Europe; delays in commercialization or product availability; changes in prescribing behaviour, reimbursement and regulatory enforcement in the markets in which the Company operates; the ability to manufacture and supply products at commercial scale; reliance on commercial and distribution partners, including Blackpoint, and on the Company’s licence rights under its agreement with Remidose; market acceptance of the products; competition from existing and new products; the accuracy of third-party market estimates; and other factors discussed in MediPharm’s filings, available on the SEDAR+ website at www.sedarplus.ca. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.

SOURCE MediPharm Labs Corp.

Source

¹ Prohibition Partners, “Sizing the European opportunity to 2029,” February 20, 2026. The source estimates European medical cannabis sales of €1.29 billion in 2025 and €2.2 billion in 2027 and states that Germany and the United Kingdom represented roughly 85% of the 2025 total. Canadian dollar equivalents are based on an estimated EUR/CAD exchange rate of 1.60 and are rounded.