Curaleaf Becomes First to Register Cannabis Preparations Under Spain’s New Medical Framework

Spain’s medicines regulator has officially approved the first two oil-based preparations as part of its recently approved national medical cannabis scheme. 

Curaleaf International has become the first company to register standardised cannabis preparations in Spain, with the Spanish Agency of Medicines and Medical Devices (AEMPS) formally approving one THC-dominant and one CBD-dominant oils, both developed by its Alicante-based manufacturing subsidiary.

The registrations, numbered CAN-1 and CAN-2 in Spain’s official registry, were granted under Royal Decree 903/2025, the framework approved by Spain’s Council of Ministers on 7 October 2025 that established the country’s first national pathway for patients to access standardised cannabis preparations through the healthcare system. 

The approved preparations are now cleared for supply to hospital pharmacies, where specialist physicians can prescribe them as magistral formulas for individual prescriptions.

Under the Spain’s medical cannabis framework, prescriptions can only be issued by specialist physicians in hospital settings. Flower, meanwhile, is explicitly excluded. 

Unlike the UK and German models, however, Spanish patients do not pay for prescriptions dispensed through hospital pharmacies, meaning revenue flows through institutional hospital procurement rather than retail or direct-to-patient channels. 

First mover

In 2020, Curaleaf’s EU-GMP laboratory Medalchemy SL secured the inaugural AEMPS licence to process medicinal cannabis derivatives for commercial distribution in Spain, a milestone we have tracked since the framework was announced. 

That existing infrastructure, including the EU-GMP certified facility and R&D laboratory in Alicante, provided the platform from which CAN-1 and CAN-2 were developed and submitted for registration. As of June 2026, only four companies held AEMPS cultivation licences in Spain

“Spain, a country of nearly 50 million people, has always been central to Curaleaf’s vision for Europe, and this registration is a defining moment for us,” said Boris Jordan, Chief Executive Officer and Chairman of Curaleaf. 

“We were the first company to be licensed here in 2020, and we believe we are the first to register under this new framework today. This achievement reflects the strength of our team, our sustained investment in science, and our conviction that patients deserve access to standardised, high-quality cannabis medicines.”

Vindication of strategy

In January this year, Juan Martinez, Chief Executive Officer of Curaleaf International, told Business of Cannabis that Europe’s emerging markets were not abandoning flower so much as choosing to launch without it, and that companies with pharmaceutical-grade oil and device formats were therefore better positioned than those whose European franchises were built on dried flower.

“Both France and Spain have launched highly restrictive, hospital-oriented programmes,” he said. “In that setting, excluding flower is a cautious choice. Standardised formats – oils, capsules, or device-delivered extracts – are easier for clinicians to prescribe, monitor, and integrate into existing clinical workflows.” 

Curaleaf had already positioned itself to capitalise on this emerging trend in the UK, where it launched Europe’s first CE-certified liquid cannabis inhaler, a Class IIa medical device developed over five years with Jupiter Research LLC, in September 2025. 

That positioning is looking increasingly well-timed, coming just days after Germany’s parliament voted to remove cannabis flower from statutory health insurance reimbursement and mandate a six-month extract-only trial period, adding the continent’s largest market to the list of jurisdictions where non-flower formats are gaining structural advantage.

Curaleaf’s double first (first licensed in 2020, first registered in 2026) gives it the strongest existing position in the emerging Spanish market.