Medical cannabis in Spain is no longer a debate — it is a regulated pathway that is now up and running. Royal Decree 903/2025, approved on 7 October 2025, set the conditions for preparing and dispensing standardized compounded cannabis formulations. In 2026, the missing pieces arrived for the system to actually work.
From the official gazette to clinical practice
The Spanish model is deliberately conservative: formulations can only be prescribed by hospital specialists, and preparation is reserved for hospital pharmacy services. No dried flower and no dispensing at community pharmacies: the circuit is hospital-based end to end, built on standardized preparations registered with the Spanish Agency of Medicines and Medical Devices (AEMPS) to guarantee quality, safety and dosing.
The AEMPS registry is live
In January 2026 the AEMPS published the procedure to enrol products in its Registry of Standardized Cannabis Preparations — the essential step for a preparation to be used in compounded formulations. Shortly after, the National Formulary incorporated the first specific monograph, an oral oily solution with THC and/or CBD, defining how it must be prepared, dosed and prescribed.
The industrial translation: there is now a legal, documented and auditable route to make medical cannabis available to patients in Spanish hospitals.
An opportunity few are seizing (so far)
As reported by Público, only two companies have so far positioned themselves to supply hospitals, partly because of the model’s constraints. Read through a business lens, that scarcity is an entry window: whoever arrives with a standardized product, EU-GMP certification and a solid dossier will find a market with little competition and real clinical demand.
The European context pushes in the same direction: Germany keeps driving demand for EU-GMP imports after its reform, and Europe is consolidating as the world’s second-largest cannabis market by value, even with a country-by-country regulatory map.
What it means for business
- Producers and laboratories: the AEMPS registry is the entry door; EU-GMP certification and standardization are the toll.
- Pharmaceutical distribution: the hospital circuit demands specific logistics and traceability — natural ground for established pharma operators.
- Professional services: regulatory compliance, analytics and regulatory affairs gain weight across the Spanish value chain.
European medical cannabis regulation will be one of the core themes of the Spannabis B2B Bilbao 2027 programme (11 March, VIP Room, BEC). If your company wants a position in this market, you can book a professional ticket or request a B2B Table to do business with the sector’s key players.