Royal Decree 824/2010 of 25 June 2010 Regulating Pharmaceutical Laboratories, Manufacturers Of Active Ingredients For Pharmaceutical Use And Trade Of Drugs And Medicines In Research (Spanish version)

https://www.boe.es/buscar/doc.php?id=BOE-A-2010-10827

Royal Decree 65/2006 of January 30, which establishes requirements for the import and export of biological samples (Spanish)

https://www.boe.es/buscar/act.php?id=BOE-A-2006-1916&tn=1&p=20091127

Law 9/2003, of April 25, which establishes the legal regime for confined use, voluntary release and commercialization of genetically modified organisms

https://www.boe.es/buscar/doc.php?id=BOE-A-2003-8588

Royal Decree 178/2004, of January 30, which approves the General Regulation for the Development and Execution of Law 9/2003

https://www.boe.es/buscar/doc.php?id=BOE-A-2004-1850

Royal Decree 1716/2011, of November 18, which establishes the basic requirements for the authorization and operation of biobanks for the purposes of biomedical research and the treatment of biological samples of human origin, and regulates the operation and organization of the National Registry of Biobanks for biomedical research.

https://www.boe.es/buscar/doc.php?id=BOE-A-2011-18919

Organic Law 3/2018, of December 5, Protection of Personal Data and guarantee of digital rights.

https://www.boe.es/eli/es/lo/2018/12/05/3

Royal Decree 957/2020, of 3 November, regulating observational studies with medicines for human use (Spanish)

https://www.boe.es/buscar/act.php?id=BOE-A-2020-14960

Instruction Document of the AEMPS for Conducting Clinical Trials, version 19, dated November 24, 2023

https://www.aemps.gob.es/investigacionClinica/medicamentos/docs/Instruction-Document.pdf

Law 41/2002, of 14 November, Basic Law Regulating Patient Autonomy and Rights and Obligations in Matters of Clinical Information and Documentation (Spanish)

https://www.boe.es/boe/dias/2002/11/15/pdfs/A40126-40132.pdf

Circular 1/ 2015 issued by the AEMPS regarding Foreign Trade of Medicines (Spanish)

https://www.aemps.gob.es/informa/circulares/medicamentosUsoHumano/2015/docs/circular_1-2015-comercio-exterior-medicamentos.pdf

CEIm- Common Specific Criteria for Accreditation, Inspection and Renewal_Spanish

https://www.aemps.gob.es/investigacionClinica/medicamentos/docs/criterios-acreditacion-CEIm.pdf

AEMPS Regulations on Clinical Trials with Medicinal Products for Human Use

https://www.aemps.gob.es/legislacion_unioneuropea/normativa-sobre-ensayos-clinicos-con-medicamentos-de-uso-humano/

AEMPS: Payment of Fees Portal

https://tasas.aemps.es/tasas/gestion/inicio?locale=en

AEMPS: Fees Page

https://sede.aemps.gob.es/tasas/

AEMPS- Annex 1_v31st Jan 2022 (English)

https://www.aemps.gob.es/investigacionClinica/medicamentos/docs/annex1-Ins-AEMPS-EC.pdf

AEMPS- CTIS Guidance for Sponsor-Spain- V2_June 2023

https://www.aemps.gob.es/legislacion/espana/investigacionClinica/docs/CTIS-Guidance-v2-june.pdf

AEMPS Page to Annex (Templates)

https://www.aemps.gob.es/medicamentos-de-uso-humano/investigacion_medicamentos/ensayosclinicos/annexes-to-instruction-document-of-the-spanish-agency-of-medicines-and-medical-devices-for-conducting-clinical-trials-in-spain/

CEIm- Common Specific Criteria for Accreditation, Inspection and Renewal_Spanish

https://www.aemps.gob.es/investigacionClinica/medicamentos/docs/criterios-acreditacion-CEIm.pdf

List of CEIMs part of the CTIS

https://www.aemps.gob.es/medicamentos-de-uso-humano/investigacion_medicamentos/ceim-adheridos-al-trabajo-en-ctis/

Official website of The Ministry for the Ecological Transition and the Demographic Challenge

https://www.miteco.gob.es/es/calidad-y-evaluacion-ambiental/temas/biotecnologia/organismos-modificados-geneticamente-omg-/notificaciones-y-autorizaciones/proc_autorizacion.html

AEMPS- Procedure of authorization of pharmaceutical labs (Spanish)

https://www.aemps.gob.es/industria-farmaceutica/laboratorios-farmaceuticos-autorizacion-modificacion-y-registro/procedimiento-de-autorizacion-de-laboratorios-farmaceuticos/

Ministry of Health (Spanish)-Biological Samples

https://www.sanidad.gob.es/areas/sanidadExterior/materialBiologico/muestrasBiologicas/home.htm

Ministry of Health-Electronic headquarters

https://sede.mscbs.gob.es/en/registroElectronico/formularios.htm

Central Mercantile Register

https://www.rmc.es/Home.aspx?lang=en

Official website of Spanish Registry of Clinical Studies

https://reec.aemps.es/reec/public/web.html

Spanish Code of Conduct Regulating the Processing of Personal Data in Clinical Trials and Other Clinical Research and Pharmacovigilance Activities (Spanish version)

https://www.aepd.es/documento/codigo-conducta-farmaindustria-cc-0007-2019.pdf

Spanish Code of Conduct Regulating the Processing of Personal Data in Clinical Trials and Other Clinical Research and Pharmacovigilance Activities (Non-official English translation)

https://www.aepd.es/documento/farmaindustria-code-conduct-regulating-processing-personal-clinical-en.pdf

Opinion 2/2016 on the impact of the Legislative Reform operated by the RD 1090/2015 of the 04 December 2015 on the intervention of the Public Prosecutor's Office in Clinical Trials and Biomedical Research.

https://www.fiscal.es/documents/20142/157164/Dictamen+2-2016+sobre+Ensayos+Clinicos+e+investigaci%C3%B3n+biomedica.pdf/56bb9eef-99a6-6f96-22fd-2318fb7a5eaa?version=1.1

Law 14/2007 of the 03 July

https://www.boe.es/buscar/doc.php?id=BOE-A-2007-12945

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