Spain Launches Registration Process for Standardized Medical Cannabis Preparations

The Spanish Agency for Medicines and Health Products (AEMPS) began the procedure this Monday for pharmaceutical laboratories that are going to make standardized cannabis preparations to register them.

To request the inclusion of these cannabis preparations, the companies responsible for their manufacture and placement on the market must submit the corresponding application through the electronic registry of the AEMPS, accompanied by the information relating to the cannabis preparations included in the Royal Decree of October 7th that regulates the medicinal use of cannabis for certain clinical conditions.

The royal decree in Spain regulates the use of standardized magistral formulas made from standardized cannabis preparations for medicinal use as a therapeutic alternative in cases where conventional treatments are not effective, especially in patients with refractory chronic pain, severe epilepsy, spasticity due to multiple sclerosis, or to alleviate nausea and vomiting resulting from chemotherapy.

All standardized cannabis preparations used to make magistral formulas must be included in the register

These cannabis preparations must have a defined THC and/or CBD composition, comply with stringent manufacturing, traceability, and quality requirements, and are subject to additional oversight when they contain more than 0.2% THC. The responsible laboratories in Spain will be required to guarantee proper manufacturing and distribution, as well as to document and audit their supply chain.

Medical cannabis formulations may be prescribed solely by specialist physicians, and only within a hospital setting, when there are clearly documented clinical justifications that support their use for a specific patient. The preparation of these medical cannabis products is strictly limited to authorized hospital pharmacy services. These services must carry out all preparation activities in full compliance with the established rules of good preparation practices, as well as in accordance with the technical standards and criteria set out in the national formulary.

In the same way, the ongoing monitoring of medical cannabis treatment constitutes a shared responsibility. This responsibility lies jointly with the prescribing physician and the hospital pharmacy service. Together, they are required to conduct periodic evaluations of the treatment, assessing both its clinical effectiveness and the possible emergence of adverse effects, in order to ensure patient safety and appropriate therapeutic outcomes.

Only in exceptional circumstances—such as situations involving particular vulnerability, dependency, or significant geographical barriers—may the autonomous communities implement non-face-to-face dispensing mechanisms. These exceptional measures must be designed and applied in a manner that guarantees equitable access to medical cannabis treatments, without compromising the standards of care or patient safety.

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