February opened a consultation on medicines
Spain’s Health Ministry opened a preliminary public consultation from 13 February to 4 March 2024 on conditions for preparing and dispensing magistral medicines based on standardised cannabis preparations. Citizens, organisations and associations could submit their views before the regulatory text was developed. The ministry announced the process on 14 February. Its subject was a medical route built around product quality and patient safety, rather than a national system of adult-use shops.
[1] Health Ministry — Consultation announcement, February 2024[3] Health Ministry — 2024 draft decree
September brought a text for public comment
On 30 September 2024, the ministry published the draft for a hearing and public-information stage, with contributions accepted until 21 October. This was a second opportunity for participation: the preliminary consultation had gathered views on the proposed initiative, while the autumn stage placed an actual draft before the public. The administrative process therefore progressed from defining a regulatory problem to considering the wording and institutional responsibilities of a proposed solution.
The legal power concerned pharmaceutical products
The draft identified Article 149.1.16 of the Constitution, covering state competence over pharmaceutical legislation, as its principal constitutional basis. This explains why the reform concentrated on preparations, quality and professional responsibilities. A medicines regulation can establish a controlled clinical pathway through manufacturers, prescribers and pharmacies. It does not perform the same legal work as changing criminal offences or creating commercial licences for a general consumer market. The selected administrative instrument shaped the reach of the reform.
The outcome arrived in October 2025
Royal Decree 903/2025 was adopted on 7 October and published in the BOE on 9 October 2025. It established conditions for standardised cannabis preparations used in defined magistral medicines, with AEMPS registration and quality requirements, specialist prescribing and hospital-pharmacy responsibilities. The process begun in 2024 thus produced a pharmaceutical framework the following year. Its institutional outcome was specific: medicines oversight, clinical responsibility and regulated preparation. Broader adult-use legalisation remained a separate political and legislative question, outside the authorisation created by this decree.
Sources & further reading
General information, not individual legal or medical advice.