First anniversary of the legalization of medicinal cannabis in Spain

by on 09/11/2026 with No Comments

legalisation of medicinal cannabis in Spain

In this article, we are pleased to celebrate this development and update the information we provided in an earlier post on our blog, "Therapeutic Cannabis in Spain: Sativex and Crumbs", in which we discussed the imminent introduction of legislation by the authorities to regulate the use of medicinal cannabis in our country.
The regulatory process for medicinal cannabis began in October 2021 with the creation of a subcommittee in the Spanish Congress of Deputies. A document was drawn up in June 2022 and submitted for consultation on two occasions. After undergoing a review by the European Union, and following sustained efforts by numerous patient groups, the Spanish Observatory for Medicinal Cannabis (OECM) and several political parties across the parliamentary spectrum, the legislation was finally approved on 7 October 2025, with the publication of Royal Decree 903/2025 in the Official State Gazette (BOE).
This Royal Decree, which celebrated its first anniversary just over a month ago, places considerable restrictions on the use of medicinal cannabis: it may only be prescribed by specialist doctors, not general practitioners, and it may only be dispensed through hospital pharmacies, not community pharmacies on the high street.
Patient associations consider both provisions to be a serious mistake, as they significantly restrict patients' access to medicinal cannabis treatments.
The Royal Decree drafted by the Ministry of Health also fails to specify which conditions may be treated, leaving these to be determined and adjusted in line with scientific evidence.
As a result, the decree excludes many conditions for which patients are already reporting benefits, such as fibromyalgia, anxiety, insomnia, post-traumatic stress disorder and migraines.
In the words of many specialists, “It does not go far enough and will not solve patients' real problems, addressing only a very specific part of them.”
The general view among the sectors involved is that the scope of the legislation does not fully reflect the actual needs identified in clinical practice.
legalización del cannabis medicinal en España
The community pharmacy profession advocates for an active role in the formulation and monitoring of medicinal cannabis treatments.

Key Features of the Regulations

  • Permitted form: The use or dispensing of the cannabis plant or its buds (flowers) is not permitted. Only magistral formulations prepared from standardised THC (tetrahydrocannabinol) and CBD (cannabidiol) preparations are allowed.
  • Therapeutic indications: Their use is restricted to cases in which conventional treatments have proved ineffective, focusing on four areas:
    • Refractory chronic pain.
    • Severe forms of refractory epilepsy.
    • Spasticity associated with multiple sclerosis.
    • Nausea and vomiting resulting from chemotherapy.

  • Prescription and dispensing:
    • They may only be prescribed by medical specialists.

    • They are prepared and dispensed exclusively by hospital pharmacy services.

    • Individualised clinical monitoring is required, together with documentation in the patient's medical record.

  • Route of administration: Administration is strictly oral (in the form of oil-based solutions); inhalation (smoking or vaporising) is prohibited.

  • Oversight: The entire process is supervised and regulated by the Spanish Agency of Medicines and Medical Devices (AEMPS).

FAQs

Does the law legalize the consumption of cannabis for medicinal use?
No at least, not if cannabis is understood as the flowering tops (buds) of the cannabis plant. The law regulates and permits the use of THC (Delta-9-tetrahydrocannabinol) and CBD (cannabidiol) within the context of pharmaceutical compounded preparations. In short, the door is opened to the use of THC and CBD exclusively within a pharmacological framework.
Ultimately, although this Royal Decree represents only a very limited step forward and comes with plenty of “buts”, it is still a step in the right direction.
The million-dollar question is: what will happen if the People's Party (PP), in coalition with Vox, wins the next election? Will they repeal this Royal Decree and send us backwards once again?
The answer to these questions lies in our hands or, more precisely, in our votes.