WTO notification · TBT
EcuadorUpdated: check whether it is now adopted or in force
Draft Substitute Sanitary Technical Regulation for Good Manufacturing Practices for Medicinal Gases.
Proyecto de Normativa Técnica Sanitaria Sustitutiva para las Buenas Prácticas de Manufactura de Gases Medicinales.
Ecuador issued an addendum on 29 January 2026 to the earlier TBT notification G/TBT/N/ECU/556. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 21 October 2025. The comment period closed on 20 December 2025.
Expodite puts notifications like this one in your Updates centre, matched to the HS codes of your products and the markets you export to. Opens the requirements check for Ecuador in your Expodite account.
Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.
Published here:
Updated here:
Products applicable to good manufacturing practices of medicinal gases
Productos aplicables a buenas prácticas de manufactura de gases medicinales
The comment period closed on 20 December 2025. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/ECU/556/Add.1; it can take them up with Ecuador.
Find your country's enquiry point on WTO ePing (opens in a new tab)Latest notice (G/TBT/N/ECU/556/Add.1, 29 January 2026)
Substitute Sanitary Technical Regulations for good manufacturing practices for medicinal gases
The Republic of Ecuador hereby notifies Resolution ARCSA-DE-2025-053-DASP through which the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez) issued the Substitute Sanitary Technical Regulations for good 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/556/Add.1- 2 - manufacturing practices for medicinal gases. The notified Resolution establishes the requirements and guidelines for granting the certificate of good manufacturing practices to pharmaceutical laboratories where medicinal gases intended for marketing within Ecuadorian territory are produced.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:
The objective of the mentioned draft regulation is to establish the requirements and guidelines under which the Agency for Regulation, Control and Health Surveillance (Agencia de Regulación, Control y Vigilancia Sanitaria, ARCSA) shall grant the Good Manufacturing Practices certificate to pharmaceutical laboratories for medicinal gases, in order to guarantee the quality of the products used in patients. Once the Sanitary Technical Regulation is issued and in force, it shall be mandatory for all natural or legal persons who are owners, legal representatives, technical managers, or technical directors of pharmaceutical laboratories, whether national or foreign, in which medicinal gases intended for commercialization in the Ecuadorian territory are manufactured.
El objeto del proyecto normativo en mención, es establecer los requisitos y lineamientos bajo los cuales la ARCSA otorgará el certificado de Buenas Prácticas de Manufactura a los laboratorios farmacéuticos de gases medicinales, con la finalidad de garantizar la calidad de los productos utilizados en pacientes. Una vez emitida y en vigencia la Normativa Técnica Sanitaria, será de cumplimiento obligatorio para todas las personas naturales o jurídicas que sean propietarios, representantes legales, responsables técnicos, directores técnicos de los laboratorios farmacéuticos, nacionales o extranjeros, en los cuales se fabriquen gases medicinales destinados a su comercialización en el territorio ecuatoriano.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/ECU/556/Add.1
Substitute Sanitary Technical Regulations for good manufacturing practices for medicinal gases
The Republic of Ecuador hereby notifies Resolution ARCSA-DE-2025-053-DASP through which the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez) issued the Substitute Sanitary Technical Regulations for good 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/556/Add.1- 2 - manufacturing practices for medicinal gases. The notified Resolution establishes the requirements and guidelines for granting the certificate of good manufacturing practices to pharmaceutical laboratories where medicinal gases intended for marketing within Ecuadorian territory are produced.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:
Regular notificationG/TBT/N/ECU/556
Comment deadline: Closed on 20 December 2025
Draft Substitute Sanitary Technical Regulation for Good Manufacturing Practices for Medicinal Gases.
Proyecto de Normativa Técnica Sanitaria Sustitutiva para las Buenas Prácticas de Manufactura de Gases Medicinales.
The objective of the mentioned draft regulation is to establish the requirements and guidelines under which the Agency for Regulation, Control and Health Surveillance (Agencia de Regulación, Control y Vigilancia Sanitaria, ARCSA) shall grant the Good Manufacturing Practices certificate to pharmaceutical laboratories for medicinal gases, in order to guarantee the quality of the products used in patients. Once the Sanitary Technical Regulation is issued and in force, it shall be mandatory for all natural or legal persons who are owners, legal representatives, technical managers, or technical directors of pharmaceutical laboratories, whether national or foreign, in which medicinal gases intended for commercialization in the Ecuadorian territory are manufactured.
El objeto del proyecto normativo en mención, es establecer los requisitos y lineamientos bajo los cuales la ARCSA otorgará el certificado de Buenas Prácticas de Manufactura a los laboratorios farmacéuticos de gases medicinales, con la finalidad de garantizar la calidad de los productos utilizados en pacientes. Una vez emitida y en vigencia la Normativa Técnica Sanitaria, será de cumplimiento obligatorio para todas las personas naturales o jurídicas que sean propietarios, representantes legales, responsables técnicos, directores técnicos de los laboratorios farmacéuticos, nacionales o extranjeros, en los cuales se fabriquen gases medicinales destinados a su comercialización en el territorio ecuatoriano.
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.