Curaleaf Holdings has announced that two standardized cannabis preparations developed by its Spanish manufacturing subsidiary have received formal registration approval from Spain’s Agency for Medicines and Medical Devices (AEMPS). The approved products include a tetrahydrocannabinol (THC)-dominant and a cannabidiol (CBD)-dominant formulation. With its official registration number, Curaleaf becomes the first company to complete the registration of standardized cannabis preparations under Spain’s new regulatory framework.

This registration is based on Royal Decree 903/2025, approved by the Spanish cabinet on October 7, 2025. The decree establishes, for the first time, a national regulatory framework for standardized medicinal cannabis preparations, specifying production requirements, quality standards, and the registration process with AEMPS. It creates a formal pathway for patients to access these standardized preparations through the public healthcare system. Under this framework, approved preparations will be supplied to hospital pharmacies for compounding standard formulations as prescribed. The decree stipulates that such preparations are to be used only for specific indications, including spasticity in multiple sclerosis, refractory epilepsy, chemotherapy-induced nausea and vomiting, and refractory chronic pain, and only as a last resort when other treatment options have failed.

This achievement builds upon Curaleaf's established presence in the Spanish market. The company operates an EU GMP-certified production facility and R&D laboratory in Alicante. In May 2020, its EU GMP laboratory received the first commercial processing license for medicinal cannabis derivatives from AEMPS, laying the groundwork for this recent breakthrough.

The company's Executive Chairman stated that Spain, with a population of nearly 50 million, has always been a cornerstone of Curaleaf's European strategy, and this registration marks a significant moment for the company. He noted that after being the first to obtain a license in 2020, the company is now the first to complete registration under the new framework. This accomplishment reflects the team's capabilities, ongoing commitment to science, and belief in providing patients with access to standardized, high-quality cannabis medicines. In line with the new framework's requirements, these standardized preparations are expected to be supplied to patients through hospital pharmacies in due course.