WTO notification · TBT
EcuadorIn force, according to its latest notice
Official title
Proyecto 'Normativa Técnica Sanitaria Sustitutiva para la obtención del registro sanitario, control y vigilancia de productos biológicos de uso humano' (Draft Substitute Sanitary Technical Regulation for the issuance of sanitary certificates for, and the control and surveillance of, biological products for human use) (100 pages, in Spanish)
Ecuador issued an addendum on 12 February 2026 to the earlier TBT notification G/TBT/N/ECU/547. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 17 September 2024. The comment period closed on 16 November 2024.
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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.
Published here:
Updated here:
The draft Substitute Sanitary Technical Regulation for the issuance of sanitary certificates for, and the control and surveillance of, biological products for human use will replace Ministerial Decision No. 00385-2019 issuing the Regulation for the issuance of sanitary certificates for, and the cont
Latest notice (G/TBT/N/ECU/547/Add.4, 12 February 2026)
The latest notice says the measure has entered into force.
Instructivo Externo IE-B.3.2.1-MB-02, versión 4, denominado 'Inscripción, reinscripción, modificación y cancelación del registro sanitario de productos biológicos de uso humano' (External Instruction IE-B.3.2.1-MB-02, version 4, entitled 'Registering, re-registering, and modifying and cancelling the health registration of biological products for human use')
External Instruction IE-B.3.2.1-MB-02, version 4, entitled 'Registering, re-registering, and modifying and cancelling the health registration of biological products for human use', in application of the guidelines laid down in Resolution ARCSA-DE-2024-049-DASP, issuing 'Substitute Technical Health Regulations on the health registration, control and surveillance of biological products for human use', published in Official Journal No. 726 of 21 January 2025.The Republic of Ecuador hereby notifies Resolution ARCSA-DE-2026-002-DASP through which the National Agency for Health Surveillance, Regulation and Control (ARCSA, Doctor Leopoldo Izquieta Pérez) issued version 4 of External Instruction IE-B.3.2.1-MB-02: Registering, re-registering, and 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/547/Add.4- 2 - modifying and cancelling the health registration of biological products for human use, which entered into force on 23 January 2026, superseding Resolution ARCSA-DE-2025-021-DASP.Contact details of agency or authority designated to handle comments regarding the notification:Agency:Agencia Nacional de Regulación, Control y Vigilancia Sanitaria - ARCSA (National Agency for Health Surveillance, Regulation and Control), Doctor Leopoldo Izquieta PérezMinisterio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP…
The purpose of the notified draft Substitute Sanitary Technical Regulation is to establish the legal and technical requirements that will ensure quality, safety and efficacy and under which sanitary certificates will be issued for biological products for human use, as well as the criteria for the control and surveillance of such products. The following products are not covered by the notified draft Regulation: a. Allergen products prepared on the basis of an individual prescription by a qualified and authorized medical professional; b. Advanced therapy products not industrially manufactured, prepared on occasion by a hospital facility under the exclusive professional responsibility of a trained physician to fulfil an optional individual prescription for a made-to-measure product for a single patient; and c. Research products, which are governed by Ministerial Decision No. 0075-2017 issuing the Regulation for the approval, development, surveillance and control of clinical trials, or any document that might replace it. The draft Substitute Sanitary Technical Regulation is binding on all natural or legal persons, whether domestic or foreign, governed by public or private law, that request sanitary certification, re-certification or an amendment thereto for biological products for human use in the country.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/ECU/547/Add.4
Instructivo Externo IE-B.3.2.1-MB-02, versión 4, denominado 'Inscripción, reinscripción, modificación y cancelación del registro sanitario de productos biológicos de uso humano' (External Instruction IE-B.3.2.1-MB-02, version 4, entitled 'Registering, re-registering, and modifying and cancelling the health registration of biological products for human use')
External Instruction IE-B.3.2.1-MB-02, version 4, entitled 'Registering, re-registering, and modifying and cancelling the health registration of biological products for human use', in application of the guidelines laid down in Resolution ARCSA-DE-2024-049-DASP, issuing 'Substitute Technical Health Regulations on the health registration, control and surveillance of biological products for human use', published in Official Journal No. 726 of 21 January 2025.The Republic of Ecuador hereby notifies Resolution ARCSA-DE-2026-002-DASP through which the National Agency for Health Surveillance, Regulation and Control (ARCSA, Doctor Leopoldo Izquieta Pérez) issued version 4 of External Instruction IE-B.3.2.1-MB-02: Registering, re-registering, and 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/547/Add.4- 2 - modifying and cancelling the health registration of biological products for human use, which entered into force on 23 January 2026, superseding Resolution ARCSA-DE-2025-021-DASP.Contact details of agency or authority designated to handle comments regarding the notification:Agency:Agencia Nacional de Regulación, Control y Vigilancia Sanitaria - ARCSA (National Agency for Health Surveillance, Regulation and Control), Doctor Leopoldo Izquieta PérezMinisterio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP…
AddendumG/TBT/N/ECU/547/Add.3
Instructivo Externo IE IE-B.3.2.1-MG-01, versión 4, denominado 'Inscripción, reinscripción, modificación y cancelación voluntaria del registro sanitario de medicamentos en general de uso humano' (External Instruction IE IE-B.3.2.1-MG-01, version 4, entitled 'Sanitary registration and re-registration, and modification and voluntary cancellation of sanitary registration, for medicines in general for human use')
The Republic of Ecuador hereby notifies Resolution No. ARCSA-DE-2025-034-DASP through which the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez) issued External Instruction IE-B.3.2.1-MG-01, version 4, entitled 'Sanitary 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/547/Add.3 - 2 - registration and re-registration, and modification and voluntary cancellation of sanitary registration, for medicines in general for human use', in application of the guidelines laid down in Resolution No. ARCSA-DE-2024-058-DASP, which issued the 'Substitute Sanitary Technical Regulations for the sanitary registration, control and surveillance of medicines in general for human use', published in Official Journal No. 731 of 28 January 2025 (notified via the ePing platform in document G/TBT/N/ECU/546). Notification Authority: Ministerio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP (Ministry of Production, Foreign Trade, Investment and Fisheries) Subsecretaría de Calidad (Under-Secretariat for Quality) Primary enquiry point: Cristian Eduardo Yépez Jaramillo Plataforma Gubernamental de Gestión Financiera Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Piso 8 Bloque amarillo Quito EC170522 Tel.: (+593 2) 3948760, Ext. 2254/2252 Email…
AddendumG/TBT/N/ECU/547/Add.2
Instructivo Externo IE-B.3.2.1-MB-02, versión 3, denominado 'Inscripción, reinscripción, modificación y cancelación del registro sanitario de productos biológicos de uso humano' (External Instruction IE-B.3.2.1-MB-02, version 3, entitled 'Registration, re-registration, modification and cancellation of the sanitary registration of biological products for human use')
The Republic of Ecuador hereby advises of External Instruction IE-B.3.2.1-MB-02, version 3, entitled 'Registration, re-registration, modification and cancellation of the sanitary registration of biological products for human use'.It should be noted that Ecuador has followed all the transparency and notification guidelines determined by the WTO. Thus, on 17 September 2024, in document G/TBT/N/ECU/547, the draft Substitute Sanitary Technical Regulation for the issuance of sanitary certificates for, and the control and surveillance of, biological products for human use was notified for 60 days for comments from member countries. The Substitute Sanitary Technical Regulation for the issuance of sanitary certificates for, and the control and surveillance of, biological products for human use was notified in document G/TBT/N/ECU/547/Add.1 of 14 January 2025.Ministerio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP (Ministry of Production, Foreign Trade, Investment and Fisheries)Subsecretaría de Calidad (Under-Secretariat for Quality)TBT Enquiry PointPrimary 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/ 2252Email: puntocontacto-otcecu@produccion.gob.ec; puntocontactoecu@gmail.com; cyepez@produccion.gob.ecWebsite:
AddendumG/TBT/N/ECU/547/Add.1
'Normativa Técnica Sanitaria Sustitutiva para la obtención del registro sanitario, control y vigilancia de productos biológicos de uso humano' (Substitute Sanitary Technical Regulation for the issuance of sanitary certificates for, and the control and surveillance of, biological products for human use)
Substitute Sanitary Technical Regulation for the issuance of sanitary certificates for, and the control and surveillance of, biological products 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/547/Add.1 - 2 - The Republic of Ecuador hereby advises that the Substitute Sanitary Technical Regulation for the issuance of sanitary certificates for, and the control and surveillance of, biological products for human use has been issued pursuant to Resolution No. ARCSA-DE-2024-049-DASP of 20 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 Nacional de Periodistas y Alfonso Pereira Quito, Ecuador Tel.: (+593) 2 3948760, Ext. 2252/2254 Email…
Regular notificationG/TBT/N/ECU/547
Comment deadline: Closed on 16 November 2024
Proyecto 'Normativa Técnica Sanitaria Sustitutiva para la obtención del registro sanitario, control y vigilancia de productos biológicos de uso humano' (Draft Substitute Sanitary Technical Regulation for the issuance of sanitary certificates for, and the control and surveillance of, biological products for human use) (100 pages, in Spanish)
The purpose of the notified draft Substitute Sanitary Technical Regulation is to establish the legal and technical requirements that will ensure quality, safety and efficacy and under which sanitary certificates will be issued for biological products for human use, as well as the criteria for the control and surveillance of such products. The following products are not covered by the notified draft Regulation: a. Allergen products prepared on the basis of an individual prescription by a qualified and authorized medical professional; b. Advanced therapy products not industrially manufactured, prepared on occasion by a hospital facility under the exclusive professional responsibility of a trained physician to fulfil an optional individual prescription for a made-to-measure product for a single patient; and c. Research products, which are governed by Ministerial Decision No. 0075-2017 issuing the Regulation for the approval, development, surveillance and control of clinical trials, or any document that might replace it. The draft Substitute Sanitary Technical Regulation is binding on all natural or legal persons, whether domestic or foreign, governed by public or private law, that request sanitary certification, re-certification or an amendment thereto for biological products for human use in the country.
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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