WTO notification · TBT
EcuadorIn force, according to its latest notice
Official title
Proyecto de reforma parcial a la Normativa Técnica Sanitaria de Buenas Prácticas de Almacenamiento, Distribución y/o Transporte para establecimientos farmacéuticos y establecimientos de dispositivos médicos de uso humano (Draft Partial Amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use) (22 pages, in Spanish)
Ecuador issued an addendum on 30 September 2026 to the earlier TBT notification G/TBT/N/ECU/504. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 21 April 2021. Comments are open until 29 November 2026.
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Proyecto de reforma parcial a la Normativa Técnica Sanitaria de Buenas Prácticas de Almacenamiento, Distribución y/o Transporte para establecimientos farmacéuticos y establecimientos de dispositivos médicos de uso humano (Draft Partial Amendment to the Sanitary Technical Regulation on good practices
Latest notice (G/TBT/N/ECU/504/Add.6, 30 September 2026)
The latest notice says the measure has entered into force.
Proyecto de Reforma Sustitutiva de la Resolución ARCSA-DE-002-2020-JCGO, a través de la cual se expide la 'Normativa Técnica Sanitaria de buenas prácticas de almacenamiento, distribución y/o transporte para establecimientos farmacéuticos y establecimientos de dispositivos médicos de uso humano' (Draft substitute amendment to Resolution ARCSA-DE-002-2020-JCGO issuing the Technical Sanitary Regulations on good practices for storage, distribution and/or transportation for pharmaceutical establishme
The notified draft substitute amendment to Resolution ARCSA-DE-002-2020-JCGO issuing the Technical Sanitary Regulations on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments for medical devices for human use, is intended to establish the requirements and guidelines for granting good storage, distribution and/or transportation practices certificates to pharmaceutical establishments and medical device 1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final/modified measure and/or interpretative guidance can be obtained.G/TBT/N/ECU/504/Add.6- 2 - establishments that store, distribute and transport medicinal products in general, medicinal gases, medicines containing controlled substances, biological products, homoeopathic products or medicines, processed natural products for medicinal use, medical devices for human use, products for the pharmaceutical industry, and active pharmaceutical ingredients; with the aim of conserving the properties and maintaining the quality, safety and effectiveness of these products.The provisions set forth in these Regulations are mandatory and apply to natural and legal persons, whether domestic or foreign, established within the national territory, who are owners or legal representatives of: distributors of medicinal gases, distributors of active pharmaceutical ingredients, pharmaceutical representative…
Draft Partial Amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/ECU/504/Add.6
Comment deadline: Open until 29 November 2026
Proyecto de Reforma Sustitutiva de la Resolución ARCSA-DE-002-2020-JCGO, a través de la cual se expide la 'Normativa Técnica Sanitaria de buenas prácticas de almacenamiento, distribución y/o transporte para establecimientos farmacéuticos y establecimientos de dispositivos médicos de uso humano' (Draft substitute amendment to Resolution ARCSA-DE-002-2020-JCGO issuing the Technical Sanitary Regulations on good practices for storage, distribution and/or transportation for pharmaceutical establishme
The notified draft substitute amendment to Resolution ARCSA-DE-002-2020-JCGO issuing the Technical Sanitary Regulations on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments for medical devices for human use, is intended to establish the requirements and guidelines for granting good storage, distribution and/or transportation practices certificates to pharmaceutical establishments and medical device 1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final/modified measure and/or interpretative guidance can be obtained.G/TBT/N/ECU/504/Add.6- 2 - establishments that store, distribute and transport medicinal products in general, medicinal gases, medicines containing controlled substances, biological products, homoeopathic products or medicines, processed natural products for medicinal use, medical devices for human use, products for the pharmaceutical industry, and active pharmaceutical ingredients; with the aim of conserving the properties and maintaining the quality, safety and effectiveness of these products.The provisions set forth in these Regulations are mandatory and apply to natural and legal persons, whether domestic or foreign, established within the national territory, who are owners or legal representatives of: distributors of medicinal gases, distributors of active pharmaceutical ingredients, pharmaceutical representative…
AddendumG/TBT/N/ECU/504/Add.5
Partial amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use
The Republic of Ecuador hereby notifies that the National Agency for Health Surveillance, Regulation and Control (ARCSA, Doctor Leopoldo Izquieta Pérez) has issued the partial amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use, which entered into force on 14 January 2026.Contact details of agency or authority designated to handle comments regarding the notification:Agency:Ministerio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP (Ministry of Production, Foreign Trade, Investment and Fisheries)Subsecretaría de la Calidad (Under-Secretariat for Quality)Primary enquiry point:Cristian Eduardo Yépez JaramilloPlataforma Gubernamental de Gestión FinancieraAv. Amazonas entre Unión Nacional de Periodistas y Alfonso PereiraPiso 8Bloque amarilloQuito EC170522Tel.: (+593 2) 3948760, Ext. 2254 or 2252Email: puntocontacto-otcecu@produccion.gob.ec; puntocontactoecu@gmail.com; cyepez@produccion.gob.ecWebsite:
AddendumG/TBT/N/ECU/504/Add.4
Partial amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use
Amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use 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/504/Add.4 - 2 - By means of this Addendum, the Republic of Ecuador advises that the Amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use has been issued pursuant to Resolution No. ARCSA-DE-2024-047-DASP of 12 December 2024 of the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez). The notified Sanitary Technical Regulation will enter into force six months after its signature, without prejudice to 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: Eduardo Yépez Plataforma Gubernamental de Gestión Financiera - Piso 8 Bloque amarillo Av. Amazonas entre Unión…
AddendumG/TBT/N/ECU/504/Add.3
Comment deadline: Closed on 3 November 2024
Draft partial amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use
Draft amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use. By means of this Addendum No. 3, the Republic of Ecuador advises on the corresponding comment period for the draft partial amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use, proposed by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez). 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/504/Add.3 - 2 - 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: Patricio Álvarez Plataforma Gubernamental de Gestión Financiera - Piso 8, Bloque amarillo, Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Quito, Ecuador Tel.: (+593) 2 3948760, Ext. 2252/2254 Email: Puntocontacto-OTCECU@produccion.gob.ec PuntocontactoOTCECU@gmail.com…
AddendumG/TBT/N/ECU/504/Add.2
Partial amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use
Partial amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use By means of this Addendum No. 2, the Republic of Ecuador advises that the partial amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use has been issued pursuant to Resolution ARCSA-DE-2021-010-AKRG of 10 September 2021 by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez). The Regulation will enter into force upon publication in the Official Journal (approximate date: 10 October 2021). 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 Periodistas y Alfonso Pereira Quito, Ecuador Tel.: (+593-2) 3948760, Ext. 2252/2254 Email: Puntocontacto-OTCECU@produccion.gob.ec PuntocontactoECU@gmail.com jmarino@produccion.gob.ec cyepez@produccion.gob.ec jsanchezc@produccion.gob.ec __________
AddendumG/TBT/N/ECU/504/Add.1
Partial amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use
Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use By means of this Addendum No. 1, the Republic of Ecuador advises that the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use has been issued pursuant to Resolution ARCSA-DE-2021-009-AKRG of 10 August 2021 by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez). The Regulation will enter into force six months after its signature, without prejudice to 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 Periodistas y Alfonso Pereira Quito, Ecuador Tel.: (+593-2) 3948760, Ext. 2252/2254 Email: Puntocontacto-OTCECU@produccion.gob.ec Puntocontactoecu@gmail.com jmarino@produccion.gob.ec cyepez@produccion.gob.ec jsanchezc@produccion.gob.ec __________
Regular notificationG/TBT/N/ECU/504
Comment deadline: Closed on 20 June 2021
Proyecto de reforma parcial a la Normativa Técnica Sanitaria de Buenas Prácticas de Almacenamiento, Distribución y/o Transporte para establecimientos farmacéuticos y establecimientos de dispositivos médicos de uso humano (Draft Partial Amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use) (22 pages, in Spanish)
Draft Partial Amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use.
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
Expodite matches each notification to the markets you export to and the HS codes of your products, and puts the ones that concern you in your Updates centre, with the date comments close.