Regulation

MediPharm Inhaler Clears EU Device Review Ahead Of Planned 2027 Launch

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MediPharm Labs announced on November 5, 2026 (LABS.TO ) that BSI Group, The Netherlands B.V., identified as Notified Body 2797, had issued a positive Article 117 Notified Body Opinion for its metered-dose cannabis inhaler platform. The opinion supports MediPharm’s plan to introduce the platform as an unlicensed medicinal cannabis product in the United Kingdom and selected European markets in 2027.

For medicinal products that incorporate a device as a single integral product, an Article 117 opinion is a key European Union regulatory requirement supporting commercialization. BSI’s review provided independent confirmation that the inhaler’s device component met applicable safety, performance, design and information requirements. The milestone therefore strengthens the platform’s regulatory and commercial pathway without itself constituting a European product launch.

The planned introduction remains subject to country-specific requirements, including regulatory acceptance and import permits. The completed device review is one part of market entry, and the announcement does not establish a start date for sales in any particular country. Actual availability will depend on the national procedures applicable to each selected market.

MediPharm is the exclusive global manufacturer and licensee of the technology under a 2024 licensing agreement with Remidose Aerosols Inc. Remidose supported the application process. Blackpoint Limited will lead commercialization and distribution of Blackpoint-branded products across the United Kingdom and Europe, giving the partnership separate manufacturing, application-support and regional commercialization responsibilities.

Chief executive Greg Hunter connected the milestone to the delivery format. “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,” he said.

The initial EU portfolio includes THC 2.5 mg, THC 5 mg and balanced THC 2.5 mg:CBD 2.5 mg products. MediPharm says the platform is designed to deliver a consistent, reproducible and metered cannabinoid dose with each actuation through a compact, discreet and portable inhaler.

MediPharm characterizes the inhaler as a smoke-free alternative to conventional smoked or vaporized cannabis, with a metered-dose design intended to support more precise and repeatable dosing. Standardized API-based formulations and a defined dose per actuation are intended to support greater prescriber confidence in dose delivery and treatment consistency. These intended benefits explain why the device review matters to the company’s pharmaceutical-format positioning.

The European plan builds on products already available in other markets. MediPharm first launched metered-dose inhalers in Canada under its own brand, with THC, CBD, CBN and CBG formats in select provinces and through direct-to-patient medical platforms. It subsequently expanded to Australia, where products are available under the Beacon Medical brand and through a white-label partnership.

The immediate significance is a clearer basis for MediPharm and Blackpoint to prepare a European rollout of a platform already sold in Canada and Australia. The open question is market access: national regulatory acceptance and import permits will determine where the planned portfolio can become available, turning a positive device opinion into an actual commercial presence.

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Lena Hofmann is an AI-generated research agent for MyCannabis.com, covering cannabis regulation and policy developments in Germany and across the European Union. Her work focuses on legalization frameworks, medical cannabis programs, and the regulatory conditions shaping Europe’s emerging cannabis markets.

With a precise and compliance-driven perspective, Lena tracks legislative updates, licensing requirements, and enforcement guidance affecting consumers, businesses, and healthcare providers. She places particular emphasis on distinguishing proposed reforms from enacted law, helping readers understand what is legally permitted today—and what remains under debate.

Articles authored by Lena Hofmann are AI-generated and reviewed by MyCannabis.com’s editorial team to ensure accuracy, clarity, and responsible reporting on cannabis regulation in regulated European markets.