WTO notification · TBT
EcuadorAdopted, according to its latest notice
Official title
Reforma Parcial a la Normativa Técnica Sustitutiva para autorizar la importación por excepción e importación por donación de Medicamentos, Productos Biológicos, Dispositivos Médicos y Reactivos Bioquímicos y de Diagnóstico (Partial Amendment to the Substitute Technical Regulation to authorize the exceptional importation and importation for the purposes of donation of medicines, biological products, medical devices and biochemical and diagnostic reagents) (8 pages, in Spanish)
Ecuador issued an addendum on 9 December 2025 to the earlier TBT notification G/TBT/N/ECU/509. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 5 October 2021.
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Partial Amendment to the Substitute Technical Regulation to authorize the exceptional importation and importation for the purposes of donation of medicines, biological products, medical devices and biochemical and diagnostic reagents
Latest notice (G/TBT/N/ECU/509/Add.2, 9 December 2025)
The latest notice says the measure was adopted or published.
REFORMA PARCIAL A LA RESOLUCIÓN ARCSA-DE-016-2020- LDCL, POR MEDIO DE LA CUAL SE EXPIDE LA NORMATIVA TÉCNICA SUSTITUTIVA PARA AUTORIZAR LA IMPORTACIÓN POR EXCEPCIÓN E IMPORTACIÓN POR DONACIÓN DE MEDICAMENTOS, PRODUCTOS BIOLÓGICOS, DISPOSITIVOS MÉDICOS Y REACTIVOS BIOQUÍMICOS Y DE DIAGNÓSTICO (Partial amendment to Resolution ARCSA-DE-016-2020- LDCL, issuing the Substitute Technical Regulations authorizing the exceptional importation of and importation for the purposes of donation of medicines, bi
The Republic of Ecuador hereby notifies Resolution ARCSA-DE-2025-040-DASP, through which the National Agency for Health Surveillance, Regulation and Control (ARCSA), Doctor Leopoldo Izquieta Pérez, issues the Partial amendment to Resolution ARCSA-DE-016-2020- LDCL, issuing the Substitute Technical Regulations authorizing the exceptional importation of and importation for the purposes of donation of medicines, biological products, medical devices, and biochemical and diagnostic reagents.The purpose of aforementioned Resolution is to comply with the ruling of the Constitutional Court as set out in Judgement No. 679-18-JP/20 and joined cases, dated 5 August 2020, which establishes that 'litigated medicines' (medicines that have been the subject of lawsuits in order for patients to access them) that do not have a national health registration must have a health registration issued by a high-level health supervisory authority, to ensure that the product meets quality standards.It should be noted that Resolution ARCSA-DE-2025-040-DASP, amending Resolution ARCSA-DE-016-2020-LDCL, is not considered a technical barrier to trade because: it does not incur a cost for the applicant; the intended purpose of importing the products covered by Resolution ARCSA-DE-016-2020-LDCL is not to market them at the national level, but rather it applies only to the National Health System, the patient in their own right or their legal representative, in the following instances:• A health emergency…
Partial Amendment to the Substitute Technical Regulation to authorize the exceptional importation and importation for the purposes of donation of medicines, biological products, medical devices and biochemical and diagnostic reagents. Document for trade facilitation.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/ECU/509/Add.2
REFORMA PARCIAL A LA RESOLUCIÓN ARCSA-DE-016-2020- LDCL, POR MEDIO DE LA CUAL SE EXPIDE LA NORMATIVA TÉCNICA SUSTITUTIVA PARA AUTORIZAR LA IMPORTACIÓN POR EXCEPCIÓN E IMPORTACIÓN POR DONACIÓN DE MEDICAMENTOS, PRODUCTOS BIOLÓGICOS, DISPOSITIVOS MÉDICOS Y REACTIVOS BIOQUÍMICOS Y DE DIAGNÓSTICO (Partial amendment to Resolution ARCSA-DE-016-2020- LDCL, issuing the Substitute Technical Regulations authorizing the exceptional importation of and importation for the purposes of donation of medicines, bi
The Republic of Ecuador hereby notifies Resolution ARCSA-DE-2025-040-DASP, through which the National Agency for Health Surveillance, Regulation and Control (ARCSA), Doctor Leopoldo Izquieta Pérez, issues the Partial amendment to Resolution ARCSA-DE-016-2020- LDCL, issuing the Substitute Technical Regulations authorizing the exceptional importation of and importation for the purposes of donation of medicines, biological products, medical devices, and biochemical and diagnostic reagents.The purpose of aforementioned Resolution is to comply with the ruling of the Constitutional Court as set out in Judgement No. 679-18-JP/20 and joined cases, dated 5 August 2020, which establishes that 'litigated medicines' (medicines that have been the subject of lawsuits in order for patients to access them) that do not have a national health registration must have a health registration issued by a high-level health supervisory authority, to ensure that the product meets quality standards.It should be noted that Resolution ARCSA-DE-2025-040-DASP, amending Resolution ARCSA-DE-016-2020-LDCL, is not considered a technical barrier to trade because: it does not incur a cost for the applicant; the intended purpose of importing the products covered by Resolution ARCSA-DE-016-2020-LDCL is not to market them at the national level, but rather it applies only to the National Health System, the patient in their own right or their legal representative, in the following instances:• A health emergency…
AddendumG/TBT/N/ECU/509/Add.1
Partial Amendment to the Substitute Technical Regulation to authorize the exceptional importation and importation for the purposes of donation of medicines, biological products, medical devices and biochemical and diagnostic reagents
Partial Amendment to the Substitute Technical Regulation to authorize the exceptional importation and importation for the purposes of donation of medicines, biological products, medical devices and biochemical and diagnostic reagents 1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained. G/TBT/N/ECU/509/Add.1 - 2 - By means of this Addendum, the Republic of Ecuador advises that the Partial Amendment to the Substitute Technical Regulation to authorize the exceptional importation and importation for the purposes of donation of medicines, biological products, medical devices and biochemical and diagnostic reagents' has been issued pursuant to Resolution No. ARCSA-DE-2023-025-AKRG of 16 August 2023 by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez). The notified Regulation will enter into force on the date of its publication in the Official Journal. Text available from: Ministerio de Producción, Comercio Exterior, Inversiones y Pesca (Ministry of Production, Foreign Trade, Investment and Fisheries), Subsecretaría de Calidad (Under-Secretariat for Quality), Organismo Nacional de Notificación (National Notification Authority): TBT enquiry point: Jeannette Mariño Plataforma Gubernamental de Gestión Financiera - Piso 8 Bloque amarillo Av. Amazonas entre Unión Nacional de…
Regular notificationG/TBT/N/ECU/509
Reforma Parcial a la Normativa Técnica Sustitutiva para autorizar la importación por excepción e importación por donación de Medicamentos, Productos Biológicos, Dispositivos Médicos y Reactivos Bioquímicos y de Diagnóstico (Partial Amendment to the Substitute Technical Regulation to authorize the exceptional importation and importation for the purposes of donation of medicines, biological products, medical devices and biochemical and diagnostic reagents) (8 pages, in Spanish)
Partial Amendment to the Substitute Technical Regulation to authorize the exceptional importation and importation for the purposes of donation of medicines, biological products, medical devices and biochemical and diagnostic reagents. Document for trade facilitation.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
WTO notificationSPSProposed measure, open for commentsNew
Ecuador notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 25 December 2026.
Symbol: G/SPS/N/ECU/402Comments until 25 December 2026
WTO notificationSPSProposed measure, open for commentsNew
Ecuador notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 13 November 2026.
Symbol: G/SPS/N/ECU/401Comments until 13 November 2026
WTO notificationSPSProposed measure, open for commentsNew
Ecuador notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 13 November 2026.
No products listed by the notifying member
Symbol: G/SPS/N/ECU/400Comments until 13 November 2026
WTO notificationSPSProposed measure, open for commentsNew
Ecuador notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 13 November 2026.
No products listed by the notifying member
Symbol: G/SPS/N/ECU/399Comments until 13 November 2026
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