Spain's first medical cannabis framework is a hospital pharmacy framework

What the decree does

Real Decreto 903/2025, approved on 7 October 2025 and published in the Boletín Oficial del Estado on 9 October, establishes the conditions for prescribing, preparing, dispensing and using typified magistral formulas made from standardised cannabis preparations. It also creates a register for the standardised preparations used in those formulas, with the explicit purpose of guaranteeing their quality.

That framing is worth reading closely. The decree is not a medical cannabis product authorisation regime. It is a compounding regime, and it deliberately excludes industrially manufactured authorised medicines, investigational cannabis medicines, and cannabinoids obtained synthetically or from sources other than the cannabis plant.

The three constraints that define access

• Prescription is reserved to hospital specialists, where there are documented clinical reasons and authorised alternatives are unavailable or have proved ineffective.
• Preparation and dispensing take place only in authorised hospital pharmacy services, following correct-preparation norms and the technical criteria of the National Formulary.
• Starting material must be a standardised cannabis preparation entered in the public register maintained by AEMPS, with defined THC and CBD content and traceability requirements.

The Ministry of Health's press note made a further point that shaped expectations: the decree does not fix a closed list of indications. Authorised clinical uses, along with preparation, dosing and prescription conditions, were left to monographs to be published by AEMPS in the National Formulary.

Why the AEMPS steps decide whether this works

A compounding framework with no compliant starting material is a framework on paper. Two AEMPS actions therefore matter more than the decree itself for patients: the National Formulary monograph that defines how the typified formula must be prepared, and the procedure for entering standardised preparations in the register, published in January 2026.

The decree establishes the conditions of prescription, preparation, dispensing and use of typified magistral formulas of standardised cannabis preparations, as well as a register for the standardised preparations used in preparing them, in order to guarantee their quality.

The gap this does not close

Spain's association scene, concentrated in Catalonia and the Basque Country, is untouched by this decree and remains outside any licensing framework. Public possession and consumption remain administrative offences. Anyone reading the decree as a signal about adult-use policy is reading the wrong document.

For patients, the practical question over the coming year is not whether the framework exists but how many hospital pharmacy services are equipped and willing to prepare under it, and how many standardised preparations complete registration. LeafCurrent will follow the AEMPS register rather than announcements.