MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF) (FSE: MLZ) (“MediPharm”, “MediPharm Labs” or the “Company”), a pharmaceutical company specialized in precision-based cannabinoids, 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.”