MediPharm Labs has secured a positive regulatory opinion from BSI Group, The Netherlands B.V., marking a step toward bringing its proprietary metered-dose cannabis inhaler platform to the United Kingdom and selected European markets. The Toronto-based pharmaceutical company received a positive Notified Body Opinion under Article 117 of the European Union Medical Device Regulation, confirming that the inhaler’s device component meets applicable safety, performance, design and information requirements for medicinal products incorporating a device as an integral component.
This 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 depend on individual country requirements, including regulatory acceptance and import permits. MediPharm’s strategy involves its licensed inhalation technology platform and a partnership with Blackpoint Limited. Under a 2024 licensing agreement with Remidose Aerosols Inc., MediPharm holds exclusive global manufacturing and licensing rights to the technology.
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 inhaler aims to deliver a standardized cannabinoid dose with each actuation, providing smoke-free administration through a compact device. The metered-dose delivery system may improve dosing consistency and offer a discreet administration option for patients.
Source: drug-dev.com · Image: Contraste Vaping Setúbal – Interior of a vape shop in Setúbal, Portugal by AngeloPeixe, CC0, via Wikimedia Commons
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