Curaleaf Secures First Registration for Standardized Cannabis Preparations in Spain
Curaleaf's Spanish subsidiary has received formal approval from AEMPS to register two standardized cannabis preparations. These preparations will be available for use in hospital pharmacies for compounding magistral formulas.
Curaleaf Holdings, Inc. has become the first company to obtain registration for standardized cannabis preparations in Spain. The Spanish Agency of Medicines and Medical Devices (AEMPS) has formally approved two preparations developed by the company: one THC-dominant and one CBD-dominant.
This approval paves the way for the preparations to be supplied to hospital pharmacies. There, they can be used in the compounding of magistral formulas under medical prescription, ensuring standardized and quality-controlled medicinal products. This marks a significant step in the implementation of Spain's new regulatory framework, Royal Decree 903/2025, which establishes requirements for the production and registration of standardized cannabis products for medicinal use.
Curaleaf has an established presence in Spain, operating an EU-GMP certified manufacturing facility and R&D laboratory in Alicante. The company previously secured the first license from AEMPS in May 2020 to process medicinal cannabis derivatives for commercial distribution.
Curaleaf CEO Boris Jordan highlighted the company's long-term commitment to the Spanish market and its belief in providing patients access to standardized, high-quality cannabis medicines. The company will continue to work with healthcare professionals to support patient access as the regulated system takes shape.