Positive Article 117 Notified Body Opinion satisfies a key EU regulatory requirement foran advanced cannabis drug-device combination product and supports planned commercialization in the UK and Europe
TORONTO, November 5, 2026 (GLOBE NEWSWIRE) -- MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF)(FSE: MLZ) ("MediPharm", "MediPharm Labs" or the"Company"), a pharmaceutical company specialized in precision-basedc annabinoids, 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, anArticle 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,d esign and information requirements. This positive opinion supports a broaderr egulatory and commercial pathway for MediPharm to introduce the platform as an unlicensed medicinal cannabis product in the United Kingdom and selectedEuropean markets in 2027, subject to country-specific requirements, including regulatory acceptance and import permits.
The milestone positions MediPharm to advancethe commercialization of its licensed, proprietary inhalation technology platform through Blackpoint Limited (“Blackpoint”). MediPharm is the exclusiveglobal manufacturer and licensee of the technology under a 2024 licensingagreement with Remidose Aerosols Inc. ("Remidose"). Remidose supported the application process, and Blackpoint will lead commercializationa nd distribution activities for the Blackpoint-branded products across theUnited 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 THC2.5 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 medicinalcannabis market continues to expand. Prohibition Partners’ estimates translatet o approximately C$2.1 billion in European medicinal cannabis sales in 2025 andapproximately C$3.5 billion in 2027. Germany and the United Kingdom together represented roughly 85% of estimated European sales in 2025, aligning theplatform 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 ac onvenient, discreet and portable option. For prescribers, the standardizedAPI-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 in2015, MediPharm Labs specializes in the development and manufacture ofpurified, pharmaceutical-quality cannabis concentrates, active pharmaceuticalingredients (API) and advanced derivative products utilizing a GoodManufacturing 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 andpurpose-built facilities for delivery of pure, trusted and precision-dosedcannabis products for its customers. MediPharm Labs develops, formulates,processes, packages and distributes cannabis and advanced cannabinoid-basedproducts to domestic and international medical markets.
In 2021,MediPharm Labs received a Pharmaceutical Drug Establishment Licence from HealthCanada, becoming the only company in North America to hold a commercial-scaledomestic Good Manufacturing Practices Licence for the extraction of multiplenatural cannabinoids. This GMP licence was the first step in the Company’scurrent foreign drug manufacturing site registration with the U.S. FDA.MediPharm also has EU-GMP certification, ANVISA GMP certification from Braziland TGA compliance in Australia.
In 2023,MediPharm acquired VIVO Cannabis Inc., which expanded MediPharm’s reach tomedical patients in Canada through the Canna Farms medical e-commerce platformand in Australia and Germany through Beacon Medical Pty. Ltd. and BeaconMedical GmbH. The acquisition also included Harvest Medical Clinics in Canada,which provides medical cannabis patients with physician consultations,education and prescriptions.
The Companycarries 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 companyspecialized in the delivery of cannabinoid-based metered-dose inhalers.
Blackpointis MediPharm Labs’ exclusive sales and distribution partner in the UnitedKingdom and Europe, where it markets MediPharm’s metered-dose inhaler platformunder the Blackpoint brand.
For further information, please contact:
MediPharmLabs Investor Relations
1-416-913-7425
investors@medipharmlabs.com
Cautionary Note Regarding Forward-LookingInformation
This newsrelease contains "forward-looking information" and"forward-looking statements" (collectively, "forward-lookingstatements") within the meaning of the applicable Canadian securitieslegislation. All statements, other than statements of historical fact, areforward-looking statements and are based on expectations, estimates andprojections as at the date of this news release. Any statement that involvesdiscussions with respect to predictions, expectations, beliefs, plans,projections, objectives, assumptions, future events or performance (often butnot always using phrases such as "expects", or "does notexpect", "is expected", "anticipates" or "doesnot anticipate", "plans", "budget","scheduled", "forecasts", "estimates","believes" or "intends" or variations of such words andphrases or stating that certain actions, events or results "may" or"could", "would", "might" or "will" betaken to occur or be achieved) are not statements of historical fact and may beforward-looking statements. In this news release, forward-looking statementsrelate to, among other things, the significance of the positive Article 117Notified Body Opinion and its role in supporting the regulatory and commercialpathway for MediPharm’s pMDI platform; the planned commercialization of theplatform in the United Kingdom and selected European markets, including as anunlicensed medicinal cannabis product; the satisfaction of country-specificregulatory, import, prescribing and distribution requirements; Blackpoint’scommercialization and distribution of the Blackpoint-branded products;MediPharm’s ability to manufacture and supply the products; the expectedbenefits, differentiation and market acceptance of the platform among patientsand prescribers; demand for pharmaceutical-quality cannabinoid medicines; andestimates of the size and growth of the European medical cannabis market. Thematerial assumptions underlying these forward-looking statements include, butare not limited to, the continued availability of the regulatory pathwaysdescribed in this news release, the ability of MediPharm and Blackpoint toobtain required country-specific authorizations, the continuation of theCompany’s commercial and licensing relationships, and the Company’s ability tomanufacture and supply products in accordance with applicable GMP requirements.Forward-looking statements are necessarily based upon a number of estimates andassumptions that, while considered reasonable, are subject to known and unknownrisks, uncertainties, and other factors which may cause the actual results andfuture events to differ materially from those expressed or implied by suchforward-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 failureto receive regulatory approvals; the inability of MediPharm or Blackpoint toobtain or maintain required licences, registrations, permits, importauthorizations or other regulatory clearances; changes in the regulatorytreatment of drug-device combination products or unlicensed medicinal cannabisproducts in the United Kingdom or Europe; delays in commercialization orproduct availability; changes in prescribing behaviour, reimbursement andregulatory enforcement in the markets in which the Company operates; theability to manufacture and supply products at commercial scale; reliance oncommercial and distribution partners, including Blackpoint, and on theCompany’s licence rights under its agreement with Remidose; market acceptanceof the products; competition from existing and new products; the accuracy ofthird-party market estimates; and other factors discussed in MediPharm’sfilings, available on the SEDAR+ website at www.sedarplus.ca. There can be noassurance that such statements will prove to be accurate, as actual results andfuture events could differ materially from those anticipated in suchstatements. Accordingly, readers should not place undue reliance on theforward-looking statements and information contained in this news release. Exceptas required by law, MediPharm assumes no obligation to update theforward-looking statements of beliefs, opinions, projections, or other factors,should they change.
SOURCEMediPharm Labs Corp.
Source
¹Prohibition Partners, “Sizing the European opportunity to 2029,” February 20,2026. The source estimates European medical cannabis sales of €1.29 billion in2025 and €2.2 billion in 2027 and states that Germany and the United Kingdomrepresented roughly 85% of the 2025 total. Canadian dollar equivalents arebased on an estimated EUR/CAD exchange rate of 1.60 and are rounded.