Spain has officially introduced a regulated pathway for patients to access medical cannabis, following the government’s approval of Royal Decree 903/2025 on October 7, 2025. The new measure sets out how cannabis-based medicines can be prescribed, prepared, and dispensed across Spain.
It is a new step in the public health system, this long-awaited legislation responds to years of advocacy by patients seeking safe and regulated access for those with serious or chronic health conditions.
How Does It Work?
The legislation restricts access to specific cases where traditional treatment options fall short. Specialist doctors working in Spanish hospitals now have the ability to prescribe cannabis, but only for patients living with conditions like refractory chronic pain, severe forms of epilepsy, spasticity caused by multiple sclerosis, or complications from chemotherapy. Family doctors and private clinics aren’t part of this process — hospital supervision is mandatory.
Dispensing will take place exclusively in hospital pharmacies, in close coordination with the medical team overseeing each patient. These cannabis-based medicines must come from standardized essences and will be prepared under rigorous quality protocols. Patients shouldn’t expect to see cannabis products in regular pharmacies or over the counter.
Quality control for cannabis based medicine
A key feature of the decree is its emphasis on quality control. All standardized cannabis preparations must be registered with the Spanish Agency for Medicines and Health Care Products (Agencia Española de Medicamentos y Productos Sanitarios AEMPS), which monitors their composition (especially THC and CBD quantity) and enforces strict production and distribution standards. Any formulation with THC levels above 0.2% falls under extra regulatory scrutiny.
Importantly, the law does not set a fixed list of eligible conditions. New clinical indications can be added as scientific evidence and experience expand, giving the system some built-in flexibility. All adverse reactions must be reported to regional pharmacovigilance centers, ensuring that the standards of patient safety are maintained.
What Does This Mean for Patients and the Industry?
With Spain becoming a hub for medical cannabis production and distribution under regulated conditions, the decree signifies both a medical milestone and an industry turning point.
For Spanish patients with serious health conditions, these rules create a legal and controlled route to try cannabis-based therapies. However, the system is tightly restricted; those using cannabis recreationally or seeking treatment outside hospitals aren’t included.
From a market perspective, the decree opens up promising opportunities for pharmaceutical innovation.
