A byline by Michael Sassano
Spain’s Royal Decree on Medicinal Cannabis is now official, a long-awaited and highly significant move that finally integrates cannabis-based medicines into the national healthcare system under strict pharmaceutical controls. This marks a definitive shift away from political debate and toward evidence-based medicine, where standardized extract formulations, clinical oversight, and patient safety take center stage.
This new regulatory framework in Spain signals a decisive move toward recognizing cannabis extracts as a legitimate therapeutic agent, managed with the same rigor as any other pharmaceutical product. The implementation of this decree is a major milestone, not just for Spanish patients but for the entire European Union, as it sets a highly credible standard for the future of cannabinoid therapeutics.
The Core Pillars of the Spanish Decree
The Spanish framework is defined by several stringent, medically focused provisions:
- Prescribing Authority: Only specialist physicians in hospitals are authorized to prescribe cannabis-based formulas. This ensures that prescriptions are made with the highest level of clinical oversight and expertise.
- Dispensing Channel: Dispensing occurs exclusively through hospital pharmacies. This limits access to highly controlled environments, ensuring product integrity and proper patient tracking.
- Standardized Preparations: Preparations must be standardized THC/CBD extracts, registered with the Spanish Agency of Medicines and Medical Devices (AEMPS). No flower. This mandate for standardization is a crucial step toward achieving consistent and reproducible patient outcomes.
- Clinical Guidance: Monographs defining dosage and use are mandated for publication within three months. These monographs will provide the necessary clinical guidance for physicians to prescribe with confidence.
- Regulatory Review: A six-month regulatory review period will apply once a product dossier is submitted. This structured timeline offers clarity for manufacturers seeking to enter the market.
The Credibility Factor in the Global Market
This Spanish approach stands in sharp contrast to the regulatory struggles seen in other major European markets. While countries like the U.K., Germany, and Australia have seen their legal cannabis strategies met with attempts at new regulation to address fast advancements, Spain is starting from a position of rigorous pharmaceutical control.
The experiences in other flower-heavy markets highlight the need for this clarity:
- U.K. Headwinds: The U.K. has been grappling with attempts to clamp down on „recreational style products“ entering under special access schemes, leading to major delays and a halt on popular products. This regulatory friction has caused patient shortages and heartache for producers.
- German Quotas and Telemedicine: Germany, after seeing its market double, hit its UN importation quota for flower, causing product shortages as the cap increase stalled. Simultaneously, proposals to overhaul the telemedicine market signal a market tightening, causing uncertainty.
- Portuguese Scrutiny: Portugal faced a scandal involving grey market products, leading to months of difficulty obtaining import and export permits, with only the most compliant companies getting products through.
In all these cases, the core issue is a lack of alignment between rapid market growth and clear, pharmaceutical-grade regulation. The Spanish decree avoids this pitfall by establishing a high bar from the outset. This strategy positions Spain as a globally credible market, prioritizing compliance and patient safety above all else. Credibility is what the global cannabis-pharma sector has been waiting for.
The Opportunity for EU-GMP Producers
The opportunity presented by Spain is significant—not just for Spain, but for Europe. If properly executed, this decree creates a transparent, compliant route for EU-GMP-certified producers to supply hospitals, build real clinical data, and set the tone for the next evolution of regulated cannabinoid therapeutics across the EU.
For companies already equipped with finished-product dossiers, validated manufacturing, and hospital-ready formulations, this is a critical moment. They must align with the new framework now, before the first wave of market access begins in 2026.
The rigor demanded by the Spanish system—which mirrors the high standards of EU-GMP—is a key competitive advantage. For example, while non-compliant markets allow for speed to market with products like Novel Food pre-mix gummies or use of non-EU-GMP sourced oils, the Spanish hospital-based model mandates the stringent pharmaceutical standards that only true EU-GMP compliance can provide. This focus on standardized, pharmaceutical-grade extracts dispensed through hospital channels ensures product quality that is immediately recognized and respected by doctors and insurance companies.
While Spain may not be the largest market yet, it is undoubtedly one of the most credible. The move will likely increase the flight to the largest, best-regulated companies to fill the demand gaps created by the stringent new framework. The Spanish decree is a blueprint for how a legal cannabis market can succeed by embracing pharmaceutical rigor, ensuring that growth is sustainable and that patient safety remains the ultimate priority.
About the author
Michael Sassano is one of the most respected executives in the pharmaceutical cannabis space today. Currently, Michael serves as Interim CEO and Chairman of the Board for SOMAÍ, a leading EU-GMP vertically integrated Multi-Country Operator (MCO) company with a global distribution footprint for the largest and most advanced EU-GMP-certified cannabinoid-containing pharmaceutical extract portfolio.
Somaí is set to launch multiple versions of Oral Gums from October through January. The lineup will include medical Somaí extract and terpene Oral Gums, Rosin Oral Gums, and fast-acting Oral Gums. In addition, Cookies, Sherbinskis, and Jack Herer-branded Oral Gums will roll out across three countries.
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