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Legality · Quetiapine

Is Quetiapine legal in Spain?

Also known as: seroquel

Confirmed against a primary sourceVerified October 3, 2026
Legal status
Not a controlled substance on the text read: Quetiapine is not named in Anexo 1 or Anexo 2 of Real Decreto 2829/1977, and it is not in the 1961 Convention lists that Ley 17/1967 article 2 incorporates. Search log: «quetiapina» returned 0 whole word hits in Anexo 1, 0 in Anexo 2 and 0 in the Yellow List. Nor is it in the 1971 Convention schedules as printed in the English INCB Green List, 36th edition, 2025: «Quetiapine» returned 0 whole word hits there. The psychotropic annexes are a closed enumerated list: the stems «análog» and «isómer» return 0 and 1 hits across both annexes, the one «isómer» hit being zipeprol's own entry covering its stereoisomers, so there is no analogue or generic clause. A substance enters only when a later instrument adds its name: article 1 extends the decree to substances «o bien que en futuro puedan ser incorporadas a las Listas o la Relación», ministerial orders have amended Anexo 1, and article 4 lets the Dirección General amend Anexo 2 «mediante Resolución, podrá modificar el contenido de la Lista de principios activos contenidos en el anexo dos» (may, by resolution, amend the list of active ingredients in annex two). The lists are read as at the Real Decreto 2829/1977 consolidation published 21/04/2026 and in force from 22/04/2026. Narcotic absences are decided through Ley 17/1967 article 2 against the INCB Yellow List, 65th edition of July 2026; the INCB Green List, 36th edition updated December 2025, is a cross-check for psychotropics. Narcotics can also be designated nationally, «en el ámbito nacional por el procedimiento que reglamentariamente se establezca» (nationally, by the procedure set by regulation); Real Decreto 1194/2011 sets that procedure and so far names tapentadol and isotonitaceno, as consolidated to 8 June 2021. 1971 Convention decisions after December 2025 and 1961 Convention decisions after July 2026 were not read, and this does not rule out a later amendment.
Consequences if caught
Because no list names it, Código Penal article 368 and Ley Orgánica 4/2015 article 36.16 are not reached through a list entry. Article 368 also uses the undefined term «drogas tóxicas»; whether a court could treat an unlisted substance as one is not determined in this cell, and no instance of it for this substance was read. For medicines, article 361 punishes trading in «medicamentos, incluidos los de uso humano y veterinario, así como los medicamentos en investigación, que carezcan de la necesaria autorización exigida por la ley» where «con ello se genere un riesgo para la vida o la salud de las personas», with six months to three years; a patient holding a medicine prescribed to them is not that offence.
If prescribed or medical
Spain runs two medicine control regimes side by side: narcotic medicines under Ley 17/1967 and psychotropic medicines under Real Decreto 2829/1977. Under the medicines law the Spanish medicines agency classifies each authorised medicine, «En la autorización del medicamento, la Agencia Española de Medicamentos y Productos Sanitarios determinará sus condiciones de prescripción», as «Medicamento sujeto a prescripción médica» or «Medicamento no sujeto a prescripción médica». The Spanish medicines register (CIMA), queried on 2 October 2026 by active ingredient «quetiapina», lists 283 products carrying it of 283 records returned; their conditions are 283 prescription only (printed «Medicamento Sujeto A Prescripción Médica»).
Documentation
For an ordinary medicine the agency's guidance says the medicines law «permite a los viajeros llevar su medicación personal» (allows travellers to carry their personal medication) and recommends carrying «una prescripción/informe del médico» (a doctor's prescription or report).
Primary sources
  • Real Decreto Legislativo 1/2015 (medicines law), article 19, BOE consolidated text last updated 31/07/2026
  • boe.es
  • INCB Yellow List, 65th edition of July 2026, Spanish text
  • incb.org
  • INCB Green List, 36th edition, updated December 2025
  • incb.org
  • Ley 17/1967, de 8 de abril, article 2, BOE consolidated text last updated 13/12/2001
  • boe.es
  • CIMA, Centro de Información de Medicamentos, AEMPS, queried 2 October 2026
  • cima.aemps.es
  • AEMPS traveller guidance, updated 28 de agosto de 2026
  • aemps.gob.es
  • Ley Orgánica 4/2015, article 36.16, BOE consolidated text last updated 23/02/2021
  • boe.es
  • Código Penal (Ley Orgánica 10/1995), articles 361 and 368, BOE consolidated text last updated 09/04/2026
  • boe.es
  • Real Decreto 2829/1977, de 6 de octubre, article 1, article 4, Anexo 1 and Anexo 2, BOE consolidated text whose own note reads «Última actualización publicada el 21/04/2026», Anexo 1 in force from 22/04/2026, Anexo 2 last updated 06/06/1986
  • boe.es
  • Real Decreto 1194/2011, BOE consolidated text last updated 08/06/2021
  • boe.es
  • Based on data from the Agencia Estatal Boletín Oficial del Estado (Basado en datos de la Agencia Estatal Boletín Oficial del Estado), https://www.boe.es
  • each BOE consolidated text carries the notice «Este texto consolidado es de carácter informativo y no tiene valor jurídico.»

Court records

We have not yet assessed whether court records are publicly available for this jurisdiction.

Other substances confirmed in Spain

Same substance, other countries