Spain Regulates Medical Cannabis Use

12.12.2025

Spain has formally regulated the medical cannabis use through the approval of Royal Decree 903/2025. The decree defines the conditions under which cannabis-based medicines can be prescribed and distributed within public hospitals.

This long-anticipated measure strengthens the public health framework by providing controlled access for patients with chronic illnesses when traditional treatments do not help them.

Medical cannabis buds and extracts in a laboratory setting

Framework for the Medical Cannabis Сirculation

The regulation limits access to situations in which standard medical treatments have proven insufficient. Only specialist doctors from public hospitals are authorized to prescribe cannabis-based medicines to patients with chronic pain, epilepsy, multiple sclerosis–related spasticity, or chemotherapy complications. Primary care physicians and private medical institutions are not part of this prescribing network.

Dispensing will take place exclusively via hospital pharmacies; other pharmacies will not have cannabis-based medicines.

How Are These Medicines Produced?

Cannabis medicines are to be made from standardized cannabis extracts that are produced under strict pharmaceutical conditions. These extracts are manufactured in facilities that follow international GMP standards, where each step — from handling the plant material to producing the final extract — is controlled, documented, and audited by health authorities such as the Agencia Española de Medicamentos y Productos Sanitarios.

Once the extracts arrive at the hospital pharmacy, specialist pharmacists transform them into personalized medicines, usually in the form of oils or oral solutions known as Magistral or Master Formulas. These preparations are made to match the dose of THC and CBD prescribed by the doctor.

Because production and preparation are limited to authorized pharmaceutical facilities and hospital pharmacies, patients receive medicines with consistent strength and traceability from cultivation to dispensing. This system is designed to give doctors confidence in what they are prescribing and to ensure that patients are treated with products that meet the same standards as other prescribed medicines.

How Does It Affect Patients and Marijuana Smokers?

The Decree mainly affects a small group of patients with chronic pain, severe epilepsy, sclerosis–related spasticity, or chemotherapy complications — in a positive way. Finally, they will get an opportunity to access cannabis-based medicines in a legal way. Access is strictly medical: only hospital doctors can prescribe, only hospital pharmacies can dispense, doses are standardized, and products are made under pharmaceutical-quality rules.

The new regulation barely changes anything for recreational marijuana smokers, though. They do not gain any new legal access or protections from the new Decree, but they are still allowed to consume marijuana in private cannabis clubs if they are members.

Related Posts
Spanish Startup Authorized for Production Launch Validation
Spanish Startup Authorized for Production Launch Validation

Spanish startup Taima Growth S.L. has successfully navigated strict regulatory hurdles to secure authorization from AEMPS for medical cannabis cultivation. With a high-tech indoor facility in Burgos, the company is preparing for process validation as it sets its sights on major European export markets.

Read
Results of Two Years of Cannabis Reform in Germany
Results of Two Years of Cannabis Reform in Germany

The EKOCAN project study summarizes the results of two years of cannabis reform in Germany, noting a significant increase in home cultivation and successful decriminalization while maintaining a stable level of consumption.

Read
High Times of Cannabis Industry M&A
High Times of Cannabis Industry M&A

A new European powerhouse emerges: Canada's Organigram acquired Germany's Sanity Group for €250 million. Backed by British American Tobacco, this deal reshapes the medical cannabis landscape. Here's what to expect by late 2026.

Read
Logo signWeedMapMenu