Cultivating Europe Updates: Spain Finally Regulates Medicinal Cannabis Through Standardized Formulas

What Does Spain’s New Standardized Medicinal Cannabis Regulation Mean for Patients and the Industry?

In a landmark decision on October 7, 2025, Spain’s Consejo de Ministros approved a Royal Decree that formalizes the use of medicinal cannabis through standardized preparations — produced in hospital pharmacies under strict medical supervision.

This marks a major step in integrating cannabis-based therapies into Spain’s healthcare system and creates new opportunities (and challenges) for the broader European cannabis industry. The regulation aims to provide therapeutic alternatives for patients whose conditions have not responded to conventional treatments, while maintaining rigorous safety and quality controls.

What the New Regulation Allows

Under the new framework:

• Specialist physicians may prescribe standardized cannabis formulas when conventional treatments prove ineffective.
• These formulas must be prepared in hospital pharmacy services following “Normas de Correcta Elaboración” — strict pharmaceutical preparation protocols — and dispensed only in monitored hospital settings.
• The Spanish Agency for Medicines and Medical Devices (AEMPS) will define the specific clinical uses, doses, and prescription guidelines through monographs to be published in the National Formulary within the next three months.
• A public registry, managed by AEMPS, will track all standardized cannabis preparations used in magistral formulas. Each product must meet strict requirements for composition, traceability, manufacture, and quality.
• For any preparation containing more than 0.2% THC, additional oversight and fiscalization will apply to ensure compliance with narcotics control standards.
• Treatment monitoring will be shared between prescribing physicians and hospital pharmacy services. In exceptional cases — such as rural or vulnerable patient populations — autonomous communities may authorize non-in-person dispensing to maintain patient access.
• This regulation also restricts dispensing to hospital pharmacies, meaning public retail sales remain prohibited, as confirmed by El País and the Spanish Ministry of Health.

What Does This Mean for Patients and Professionals?

The Royal Decree does not list specific qualifying conditions. Instead, it delegates this responsibility to the AEMPS, which will determine clinical indications based on scientific evidence. These may include conditions such as chronic pain, severe spasticity from multiple sclerosis, refractory epilepsy, and chemotherapy-induced nausea — as outlined in earlier parliamentary reports — but the final list awaits publication.

This approach ensures flexibility and ongoing scientific validation while setting a new standard for regulated medical cannabis use in Europe.

The coming months will be crucial as the AEMPS releases detailed monographs and defines how these rules will be applied in practice. For patients, this represents a long-awaited step toward safe, standardized access to cannabis therapies. For professionals and companies, it signals a future shaped by compliance, research, and innovation — and an important milestone in Europe’s medical cannabis landscape.

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Reference: Ministerio de Sanidad (2025, October 7). El Ministerio de Sanidad aprueba el Real Decreto que regula las fórmulas magistrales de cannabis con fines medicinales. Retrieved from https://www.sanidad.gob.es/gabinete/notasPrensa.do?id=6761