The Spanish Agency of Medicines and Medical Devices (AEMPS) has published the procedure for registering Standardized Cannabis Preparations (THC and CBD) in the official Register, in accordance with Royal Decree 903/2025 of 7 October. Pharmaceutical laboratories responsible for the manufacture and marketing of these preparations must submit their applications electronically through the Agency’s human medicines registry (RAEFAR).
The inclusion of standardized magistral cannabis formulations in the National Formulary and its registration aims to ensure consistent quality, reproducibility, and homogeneity, enabling more predictable dosing and clinical use throughout the country. These preparations will be produced in response to a medical prescription and under the supervision of a qualified hospital pharmacist.
AEMPS communication: https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-procedimiento-de-inscripcion-en-el-registro-de-preparados-estandarizados-de-cannabis/
National Formulary: https://www.aemps.gob.es/formulario-nacional/monografias/formulas-magistrales-tipificadas/fn_2026_f…
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