🇪🇸 Medical cannabis in Spain

C — product/indication/hospital-gated. Access exists only via 'fórmulas magistrales tipificadas de preparados estandarizados de cannabis' (typified magistral formulas of standardised cannabis preparations) prescribed by hospital specialists and dispensed by hospital pharmacies.

Real Decreto 903/2025, de 7 de octubre, por el que se establecen las condiciones para la elaboración y dispensación de fórmulas magistrales tipificadas de preparados estandarizados de cannabis (Royal Decree on typified magistral formulas of standardised cannabis preparations), BOE n.º 243 of 9.10.2025, in force 10.10.2025 (Disposición final tercera). Art. 7: prescription limited to 'médicos y médicas especialistas, dentro del ámbito de atención hospitalaria' and only where no authorised industrial medicine exists or it has failed. Art. 9: dispensing by 'servicios de farmacia hospitalaria'. Art. 6: a public 'Registro de los preparados estandarizados del cannabis' run by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS, Spanish medicines agency). Disposición adicional segunda: community pharmacies (oficinas de farmacia) 'podrá ser objeto de regulación específica' — not covered now.

Source: Real Decreto 903/2025, de 7 de octubre (BOE) · read 27 September 2026

An oral solution made from a registered standardised cannabis extract, either THC-dominant or CBD-dominant, per the AEMPS monograph published in January 2026. Flower and inhaled forms are not part of the scheme; industrially made cannabinoid medicines are outside this decree.

Formulario Nacional monograph FN/2026/FMT/043 'Preparado estandarizado de cannabis (THC, CBD) solución oral' (AEMPS, Formulario Nacional page last updated 9.1.2026): THC-dominant formulas 5–150 mg/mL THC or CBD-dominant 10–150 mg/mL CBD in medium-chain triglycerides; shelf life 30 days in closed container; indications named as last-line options: 'espasticidad por esclerosis múltiple', 'formas graves de epilepsia', 'náuseas y vómitos por quimioterapia', 'dolor crónico' refractory to other treatment. Preparations with THC ≥0.2% are subject to narcotic/psychotropic controls. The decree's art. 2 covers only registered standardised preparations; inhaled flower is not provided for.

Source: AEMPS — Formulario Nacional, FN/2026/FMT/043 Preparado estandarizado de cannabis (THC, CBD) solución oral · read 27 September 2026

Only specialist doctors working in hospital care, and only after documenting that authorised medicines are unavailable or have failed; the doctor must re-evaluate benefit and safety periodically.

RD 903/2025 art. 7: prescription 'se limita a médicos y médicas especialistas, dentro del ámbito de atención hospitalaria', when 'no existan medicamentos de fabricación industrial autorizados' or these have not given a satisfactory response; the justification is recorded in the clinical history with informed consent; the prescriber 'deberá evaluar periódicamente la utilidad terapéutica y la seguridad' and stop if the benefit–risk balance is unfavourable. There is no public list of authorised prescribers; any hospital specialist may prescribe within these conditions.

Source: Real Decreto 903/2025, art. 7 (BOE) · read 27 September 2026

A hospital prescription for a magistral formula handled inside the hospital pharmacy system; THC-containing preparations are subject to Spain's narcotic/psychotropic controls. No quantity limit is set in the decree.

RD 903/2025 arts. 7 and 9: hospital prescription and hospital-pharmacy dispensing; the monograph FN/2026/FMT/043 notes that preparations with THC ≥0.2% by weight are 'sometidos a las medidas de control y restricciones' of Real Decreto 2829/1977 (psychotropic substances). The general 'Receta Oficial de Estupefacientes' (official narcotic prescription, Real Decreto 1675/2012) applies to List I narcotics dispensed in community pharmacies; how hospitals record these formulas internally is not specified in the decree. Validity and dose caps: not published.

Source: AEMPS — Estupefacientes y psicótropos (ROE, RD 1675/2012) · read 27 September 2026

Not published. The decree ties prescribing to hospital specialist care and dispensing to the hospital pharmacy; it says nothing about video consultations. A private online prescription cannot be filled, because only hospital pharmacies may prepare and dispense.

RD 903/2025 art. 7 ('ámbito de atención hospitalaria') and art. 9 (hospital pharmacy dispensing) define the pathway; no article addresses remote consultation. Since community pharmacies are excluded (Disposición adicional segunda), a telemedicine prescription outside a hospital service has no dispensing route.

Source: Real Decreto 903/2025 (BOE) · read 27 September 2026

Hospital pharmacy services only; they may have the formula made by a third-party manufacturer. Community pharmacies, mail order and home delivery are not part of the scheme.

RD 903/2025 art. 9: 'La dispensación se realizará por los servicios de farmacia hospitalaria', with pharmaceutical care and follow-up in collaboration with the medical team. Disposición adicional segunda: preparation and dispensing by oficinas de farmacia 'podrá ser objeto de regulación específica' in future; community pharmacies may only act as third-party manufacturers for hospital pharmacies. Whether outpatients are served is not excluded by the text but is at the hospital's organisation.

Source: Real Decreto 903/2025, art. 9 and DA 2ª (BOE) · read 27 September 2026

Not published. The decree contains no pricing or public-financing rule; as a hospital-pharmacy magistral formula for public-hospital patients it would normally be handled within the hospital's budget, but no official statement confirming patient cost was found.

RD 903/2025 has no article on price or financing by the Sistema Nacional de Salud (checked: none). No Ministerio de Sanidad or AEMPS page on reimbursement of these formulas was found in this session.

Source: Real Decreto 903/2025 (BOE) — no financing provision · read 27 September 2026

No public price. Neither the decree nor AEMPS publishes a price for the standardised preparations or the finished oral solution.

Not published: RD 903/2025 sets no price; the AEMPS registry page describes registration only; the Formulario Nacional monograph has no tariff.

Source: AEMPS — Preparados estandarizados de cannabis · read 27 September 2026

Spain bans driving with any drugs in the body (zero-tolerance, presence-based), but the law excludes substances used under medical prescription for a therapeutic purpose; a positive roadside test with a prescription still leads to a case-by-case assessment. Fine €1,000 and 6 points if the exclusion does not apply.

Real Decreto Legislativo 6/2015, texto refundido de la Ley sobre Tráfico, Circulación de Vehículos a Motor y Seguridad Vial (consolidated Road Traffic Act), art. 14.1: no driver may drive 'con presencia de drogas en el organismo, de las que se excluyen aquellas sustancias que se utilicen bajo prescripción facultativa y con una finalidad terapéutica'; art. 77 c) makes 'conducir con presencia de drogas en el organismo' a very serious infraction; art. 80: fine €1,000; Anexo II: loss of 6 points. Criminal liability (Código Penal art. 379) applies only where the driver is actually impaired. The AEMPS monograph warns: 'La capacidad para conducir vehículos o utilizar maquinaria puede verse afectada.'

Source: Real Decreto Legislativo 6/2015, Ley de Seguridad Vial, arts. 14, 77, 80 (BOE consolidated) · read 27 September 2026

Spain is in Schengen: residents of another Schengen state may bring their own prescribed cannabis medicine with a Schengen Art. 75 certificate (max 30 days). The Spanish page describing the certificate and the rules for non-Schengen travellers could not be opened in this session.

Not published here: the Ministerio de Sanidad pages on the 'certificado Schengen' for narcotic/psychotropic medicines returned 404 at the URLs tried, and the AEMPS narcotics page opened does not cover travellers. National rule for non-Schengen/non-EU travellers (quantity, days, permit) therefore not quoted.

Source: AEMPS — Estupefacientes y psicótropos (no traveller section) · read 27 September 2026

A visitor can only obtain cannabis in Spain by becoming a patient of a hospital specialist who decides it is indicated; there is no private prescription route. A cannabis prescription from another EU country cannot be filled: Spain excludes special (narcotic) prescriptions from cross-border recognition and only hospital pharmacies may dispense. Bring your own only with the Schengen certificate.

(1) Non-residents: RD 903/2025 sets no nationality or residency condition, but the pathway is hospital specialist care (art. 7) and hospital pharmacy (art. 9); a non-resident would need access to a Spanish hospital service (EHIC/S2 or private hospital) — not published as an explicit rule. (2) Foreign EU prescriptions: Real Decreto 81/2014 (transposing Directive 2011/24/EU), art. 20: prescriptions from another Member State may be dispensed only for industrially manufactured medicines authorised by AEMPS or centrally; art. 20.5: 'Lo dispuesto en los apartados anteriores no será aplicable a los medicamentos sujetos a receta médica especial' — narcotic prescriptions and magistral formulas are therefore outside recognition. (3) Bringing medicine in: Schengen Art. 75 certificate for Schengen residents; Spanish rule for non-Schengen/non-EU travellers not published here (official page not opened). (4) Foreign telemedicine prescription: not dispensable — follows from art. 20.5 RD 81/2014 and RD 903/2025 art. 9 (hospital pharmacy only).

Source: Real Decreto 81/2014, art. 20 Reconocimiento de recetas extendidas en otro Estado miembro (BOE consolidated) · read 27 September 2026

The scheme is new: RD 903/2025 took effect 10 October 2025, the AEMPS monograph appeared in January 2026 and the public registry of standardised preparations is being populated (AEMPS page updated 11 August 2026). A separate rule for community pharmacies is foreseen but not yet issued.

RD 903/2025 Disposición adicional primera required Formulario Nacional monographs within three months of entry into force (i.e. by 9.1.2026) — met by FN/2026/FMT/043 (Formulario Nacional page dated 9.1.2026). Art. 6: AEMPS registers standardised preparations (resolution within six months of application) via RAEFAR; AEMPS's registration page was last updated 11.8.2026. Disposición adicional segunda: community-pharmacy preparation/dispensing 'podrá ser objeto de regulación específica' — no date. The list of registered preparations could not be read on the AEMPS page (dynamic content), so how many are registered today is not stated here.

Source: AEMPS — Preparados estandarizados de cannabis (registration procedure, updated 11.8.2026) · read 27 September 2026

No official count of patients or prescriptions under the 2025 scheme has been published yet.

Not published: RD 903/2025 provides for prescriber follow-up but no public statistics; no AEMPS or Ministerio de Sanidad figure was found. The scheme became operable only after the January 2026 monograph and registry entries.

Source: AEMPS — Registro de preparados estandarizados de cannabis · read 27 September 2026