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Only hospital pharmacies can formulate and dispense medical cannabis Only specialist doctors are allowed to prescribe cannabis, not general practitioners AEMPS (Spanish medicines agency) will define each products approved indication, dosage and formulation through official monographs Cannabis formulas must be standardised preparations with defined THC and CBD content Preparations over 0.2% THC face tighter restrictions and controlled substance tracking All supply chain actors must maintain full documentation, GMP-style traceability and quality control Manufacturers must apply to AEMPS and prove their formulations meet standardisation and safety requirements Likely starting indications include MS-related spasticity, refractory epilepsy, chemotherapy-induced nausea, and chronic pain Over-the-counter sales remain prohibited under this law, which applies only to hospital use Future expansion of indications is possible based on scientific evidence and new monographs This model emphasizes safety, medical oversight and pharmaceutical-grade quality control, setting a high regulatory bar for cannabis as a true medicine

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