Spain’s Ministry of Health has committed to reviewing Royal Decree 903/2025, the rule governing medical cannabis use in the country, before the end of 2026. Less than four months remain. Javier Padilla, Secretary of State for Health, acknowledged earlier this year that the regulation has not met initial expectations and left the door open to relaxing its application «if appropriate».
The circuit as it stands
The decree, approved by the Council of Ministers in October 2025, replaced a system of exceptional authorisations with a stable framework. In January 2026 the AEMPS, Spain’s medicines agency, published the National Formulary monograph governing preparation, which allows different hospital pharmacy services to produce the same thing to the same criteria instead of improvising centre by centre.
The circuit is narrow by design. Only hospital specialists can prescribe; family doctors cannot. Preparation and dispensing belong exclusively to authorised hospital pharmacy services. Four indications are covered: spasticity associated with multiple sclerosis, severe refractory epilepsy, chemotherapy-induced nausea and vomiting, and chronic pain resistant to conventional treatment. And one single dosage form is available inside the regulated circuit: an oral oily solution with THC, CBD or both. Flower is not included.
On the industrial side the conditions are equally unambiguous. Standardised preparations are manufactured by licensed pharmaceutical laboratories, with AEMPS registration, GMP standards and a public registry providing traceability for the available formulas. Anyone who does not meet that standard is not in the market.
What is on the table
The announced review points at one specific question: where the product is dispensed. The Ministry has floated opening the door to community pharmacies and, eventually, to primary care, arguing it would bring treatment closer to patients in rural areas or with mobility problems. Community pharmacists have been claiming that role for months. From the clinical side, the Spanish Pain Society has warned that current conditions exclude patients who would fit the profile, particularly in refractory chronic pain.
Padilla has drawn the political line clearly: none of this is a step towards regulating recreational use. The review is framed as an access adjustment, not a change of model.
Meanwhile, the rollout is advancing unevenly. The regulatory scaffolding was completed on schedule, but the bottleneck has shifted to clinical practice and to each region’s capacity to adapt internal circuits, train staff and take on preparation.
What would change for companies
- Volume and demand forecasting. Moving from hospitals to the community pharmacy network multiplies dispensing points and completely changes how production and logistics are sized.
- The entry door does not move. Wherever dispensing ends up, the authorised GMP manufacturer with AEMPS registration remains the only possible supplier. Anyone without that accreditation under way will arrive late.
- Dosage forms. The scenario that matters to industry is not only where the product is handed over, but whether the monograph is extended beyond the oral oily solution.
- Traceability. The AEMPS public registry turns batch documentation and analytical quality into a commercial argument, not paperwork.
- Timing. If the review closes in the final quarter of 2026, investment decisions and supply agreements will be played out in 2027.
A topic for Bilbao
There is an underlying asymmetry that explains the sector’s interest. Spain has spent years growing medical cannabis destined almost entirely for export —the AEMPS has granted more than 220 cultivation authorisations since 2018— while maintaining one of the tightest domestic access circuits in its region. It is produced here and sold abroad. That is precisely the conversation that matters to growers, laboratories, importers and distribution.
Spannabis B2B Bilbao 2027 takes place on 11 March 2027 at the BEC VIP Room and brings the sector together to settle those questions face to face. If your company needs to close supply or distribution deals in the Spanish market, book your B2B table or check the available tickets.
Sources: Spanish Ministry of Health and El Debate.