MediPharm Labs Clears European Regulatory Hurdle for Metered-Dose Cannabis Inhaler

MediPharm Labs has secured a positive regulatory opinion from BSI Group, The Netherlands B.V., marking a key step toward bringing its proprietary metered-dose cannabis inhaler platform to the United Kingdom and selected European markets.

The Toronto-based pharmaceutical company specializing in cannabinoid products received a positive Notified Body Opinion under Article 117 of the European Union Medical Device Regulation. The assessment provides independent confirmation that the inhaler’s device component meets applicable safety, performance, design and information requirements for medicinal products incorporating a device as an integral component.

The regulatory milestone advances MediPharm’s plans to introduce the inhaler platform as an unlicensed medicinal cannabis product in the UK and select European markets in 2027. Commercial availability will remain subject to individual country requirements, including regulatory acceptance and import permits.

The commercialization strategy involves MediPharm’s licensed inhalation technology platform and its partnership with Blackpoint Limited. Under a 2024 licensing agreement with Remidose Aerosols Inc., MediPharm holds exclusive global manufacturing and licensing rights to the technology. Remidose assisted with the regulatory submission, while Blackpoint will oversee commercialization and distribution of products marketed under its brand throughout the UK and Europe.

Greg Hunter, CEO of MediPharm Labs, says the positive opinion represents an important step toward commercialization and provides additional regulatory support for the company’s cannabinoid delivery technology. He points to increasing interest in cannabinoid medicines that offer consistent dosing through established pharmaceutical delivery formats.

MediPharm initially introduced its metered-dose inhalers in Canada, where products containing THC, CBD, CBN and CBG are available in select provinces and through direct-to-patient medical platforms. The company subsequently expanded into Australia, where the products are marketed under the Beacon Medical brand and through a white-label arrangement.

The initial European product lineup is expected to include three formulations: a 2.5-mg THC inhaler, a 5-mg THC inhaler and a balanced formulation containing 2.5 mg THC and 2.5 mg CBD per dose. The platform is designed to deliver a standardized cannabinoid dose with each actuation. Unlike conventional smoked or vaporized cannabis products, the inhaler provides smoke-free administration through a compact, portable device. Its metered-dose delivery system is intended to improve dosing consistency and provide patients with a more discreet administration option. The standardized formulations and defined dose per actuation may also offer advantages for prescribers seeking greater predictability in cannabinoid delivery and treatment management.

The regulatory development comes as Europe’s medicinal cannabis market continues to grow. Estimates from Prohibition Partners indicate that European sales reached approximately $1.4 billion in 2025 and could increase to $2.4 billion by 2027. Germany and the UK accounted for approximately 85% of the region’s estimated medicinal cannabis sales in 2025, making both markets central to MediPharm’s expansion strategy.

With the Article 117 assessment complete, MediPharm and Blackpoint are preparing for the next stages of the regulatory and commercial process ahead of their targeted 2027 market introduction.

For more information, visit www.medipharmlabs.com.