Canada’s MediPharm Labs has received a positive Article 117 Notified Body Opinion (NBOp) under the EU Medical Device Regulation for its metered-dose cannabis inhaler. It was issued by BSI Group The Netherlands (Notified Body 2797), and the company announced it on 5 November. The stated goal: sell the product in the UK and selected EU markets during 2027.
What an Article 117 opinion is
Article 117 of the MDR applies to medicinal products with an integral device that form a single product, such as a pre-filled inhaler. Here the notified body does not authorise the medicine: it reviews the device part and confirms it meets the general safety and performance requirements. That report then goes into the marketing authorisation file, as explained in BSI’s Article 117 guidance.
It should be read for what it is. The opinion is a prerequisite, not a licence to sell. The company itself acknowledges that each country has its own rules, that regulatory acceptance and import permits are still needed, and that the plan is to market it as an unlicensed medicinal cannabis product (the route the UK and several European markets use for prescribed cannabis).
The product and who will sell it
The initial European portfolio has three SKUs, all metered-dose inhalers: THC 2.5 mg, THC 5 mg and a balanced THC 2.5 mg and CBD 2.5 mg per actuation. Distribution in the UK and Europe will be handled by Blackpoint Limited, an exclusive partner that will sell it under its own brand. The technology comes from Remidose Aerosols, which signed a 2024 licence making MediPharm the exclusive global manufacturer.
This is not a debut. The inhaler is already sold in Canada, in THC, CBD, CBN and CBG formats, and in Australia under the Beacon Medical brand and as a white label. MediPharm holds EU-GMP certification, a must for access to Europe’s pharmaceutical channel. The details are reported, among others, by StratCann.
Why it matters beyond one company
Europe’s medical cannabis market is still dominated by flower. In Germany, the price per gram keeps falling and competition is almost entirely about cost. A format with a measured dose per actuation changes the conversation: it looks more like a conventional medicine, fits better with how many doctors prescribe, and avoids combustion.
Prohibition Partners figures cited by the company put European sales at around €1.29 billion in 2025 and around €2.2 billion in 2027, with Germany and the UK accounting for roughly 85% of the total. The growth is there, but value is starting to shift from raw material to pharmaceutical form.
In Spain, the Royal Decree 903/2025 framework relies on standardised preparations dispensed in hospitals, with no flower. By design it rewards precise dosing, although it does not currently cover this kind of format.
Business implications
- Manufacturers and labs: drug-device combinations require a dual technical file. Anyone competing in inhaled formats needs partners with MDR experience, not just GMP.
- Distributors: MediPharm’s model (manufacturer plus exclusive distributor with its own brand) can be replicated. There is room for licensing and white-label deals in other countries.
- Importers: the opinion does not replace national permits. The real 2027 timeline will depend on each authority.
- Investors: differentiated formats are a way out of flower price compression, but the regulatory cost of entry is high.
Formats and regulation, on the table in Bilbao
The shift of medical cannabis towards regulated pharmaceutical forms, and the licensing and distribution deals it requires, is natural ground for Spannabis B2B Bilbao 2027, held on 11 March in the BEC’s VIP Hall. If you manufacture, distribute or are looking for partners to enter Europe, get your ticket or book a B2B table to meet the players moving this market.