WTO notification · TBT
EcuadorAdopted, according to its latest notice
Official title
Proyecto 'Normativa Técnica Sanitaria sustitutiva para la vigilancia y control de la publicidad y G/TBT/N/ECU/546 - 2 - promoción de medicamentos en general, productos naturales procesados de uso medicinal, productos o medicamentos homeopáticos y dispositivos médicos' (Draft Substitute Sanitary Technical Regulation on the monitoring and control of the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical dev
Ecuador issued an addendum on 24 August 2026 to the earlier TBT notification G/TBT/N/ECU/546. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 10 September 2024. The comment period closed on 9 November 2024.
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The aim of the draft Substitute Sanitary Technical Regulation on the monitoring and control of the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices is to regulate, control and monitor the advertisin
Latest notice (G/TBT/N/ECU/546/Add.3, 24 August 2026)
The latest notice says the measure was adopted or published.
Reforma parcial a la Normativa Técnica Sanitaria sustitutiva de registro sanitario de productos naturales procesados de uso medicinal, y de buenas prácticas de manufactura para laboratorios farmacéuticos de productos naturales procesados de uso medicinal, emitida mediante Resolución N.° ARCSA-DE-036-2020-MAFG, publicada en Registro Oficial N.° 362 el 04 de enero de 2021 (Partial Amendment to the Substitute Sanitary Technical Regulation on the sanitary registration of processed natural products f
By means of this Addendum No. 3, the Republic of Ecuador notifies the Partial Amendment to the Substitute Sanitary Technical Regulation on the sanitary registration of processed natural products for medicinal use, and good manufacturing practices for pharmaceutical 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/546/Add.3- 2 - laboratories working with processed natural products for medicinal use, issued pursuant to Resolution No. ARCSA-DE-036-2020-MAFG, published in Official Journal No. 362 on 4 January 2021.No comment period was provided for this notification, as the amendment falls within the principles of regulatory simplification: it does not introduce new obligations or additional costs or formalities for economic operators, and it responds exclusively to the need to harmonize national legislation with the applicable Andean Community legal framework.Official TBT agency of Ecuador:TBT enquiry point: Andrea SegoviaPlataforma Gubernamental de Gestión Financiera - Piso 1 Bloque amarillo Av. Amazonas entre Unión Nacional de Periodistas y Alfonso PereiraQuito, EcuadorTel.: (+593) 2 3948760, Ext. 2323Email:Puntocontacto-OTCECU@produccion.gob.ecPuntocontactoECU@gmail.comaesegovia@produccion.gob.ec__________
The aim of the draft Substitute Sanitary Technical Regulation on the monitoring and control of the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices is to regulate, control and monitor the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices, in accordance with the provisions of the Organic Law on Health, with a view to promoting and providing information on the rational use and proper handling of the above-mentioned products. Only products with a sanitary registration certificate classifying them as over-the-counter products may be advertised. The provisions set out in the notified draft Regulation are applicable and mandatory throughout the national territory for natural and legal persons, whether national or foreign, that are engaged in or disseminate advertising and/or promotion activities in establishments and through mass media; it concerns the products that are mentioned above and that have undergone the sanitary registration or notification in effect 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/546/Add.3
Reforma parcial a la Normativa Técnica Sanitaria sustitutiva de registro sanitario de productos naturales procesados de uso medicinal, y de buenas prácticas de manufactura para laboratorios farmacéuticos de productos naturales procesados de uso medicinal, emitida mediante Resolución N.° ARCSA-DE-036-2020-MAFG, publicada en Registro Oficial N.° 362 el 04 de enero de 2021 (Partial Amendment to the Substitute Sanitary Technical Regulation on the sanitary registration of processed natural products f
By means of this Addendum No. 3, the Republic of Ecuador notifies the Partial Amendment to the Substitute Sanitary Technical Regulation on the sanitary registration of processed natural products for medicinal use, and good manufacturing practices for pharmaceutical 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/546/Add.3- 2 - laboratories working with processed natural products for medicinal use, issued pursuant to Resolution No. ARCSA-DE-036-2020-MAFG, published in Official Journal No. 362 on 4 January 2021.No comment period was provided for this notification, as the amendment falls within the principles of regulatory simplification: it does not introduce new obligations or additional costs or formalities for economic operators, and it responds exclusively to the need to harmonize national legislation with the applicable Andean Community legal framework.Official TBT agency of Ecuador:TBT enquiry point: Andrea SegoviaPlataforma Gubernamental de Gestión Financiera - Piso 1 Bloque amarillo Av. Amazonas entre Unión Nacional de Periodistas y Alfonso PereiraQuito, EcuadorTel.: (+593) 2 3948760, Ext. 2323Email:Puntocontacto-OTCECU@produccion.gob.ecPuntocontactoECU@gmail.comaesegovia@produccion.gob.ec__________
AddendumG/TBT/N/ECU/546/Add.2
Proyecto 'Reforma parcial a la normativa técnica sanitaria sustitutiva de registro sanitario de productos naturales procesados de uso medicinal, y de Buenas Prácticas de Manufactura para laboratorios farmacéuticos de productos naturales procesados de uso medicinal (Draft Partial Amendment to the Substitute Sanitary Technical Regulation on the sanitary registration of processed natural products for medicinal use, and good manufacturing practices for pharmaceutical laboratories working with proces
The Republic of Ecuador hereby notifies the draft Partial Amendment to the Substitute Sanitary Technical Regulation on the sanitary registration of processed natural products for medicinal use, and good manufacturing practices for pharmaceutical laboratories working with processed natural products for medicinal use, issued pursuant to Resolution No. ARCSA-DE-036-2020-MAFG, published in Official Journal No. 362 on 4 January 2021. The aim of this draft amendment is to establish the quality, safety and efficacy parameters for granting sanitary registration to processed natural products for medicinal use. It also sets out the promotion, control, monitoring and penalty criteria applicable to such products and to the establishments engaged in their manufacture, storage, distribution and marketing. Moreover, it establishes requirements and guidelines for issuing good manufacturing practices certificates to national pharmaceutical laboratories that manufacture, process, package, store, distribute and transport processed natural products.Ministerio de Producción, Comercio Exterior e Inversiones (Ministry of Production, Foreign Trade and Investment)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…
AddendumG/TBT/N/ECU/546/Add.1
'Normativa Técnica Sanitaria sustitutiva para la vigilancia y control de la publicidad y promoción de medicamentos en general, productos naturales procesados de uso medicinal, productos o medicamentos homeopáticos y dispositivos médicos' (Substitute Sanitary Technical Regulation on the monitoring and control of the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices)
Draft Substitute Sanitary Technical Regulation on the monitoring and control of the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices By means of this Addendum, the Republic of Ecuador advises of the entry into force of the Substitute Sanitary Technical Regulation on the monitoring and control of the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices. It should be noted that, with respect to this Regulation, Ecuador has followed all the transparency and notification guidelines determined by the WTO. Thus, on 10 September 2024, in document G/TBT/N/ECU/546, the draft Substitute Sanitary Technical Regulation on the monitoring and control of the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices was notified for 60 days on the WTO ePing platform for comments. The Regulation has been issued pursuant to Resolution No. ARCSA-DE-2024-048-DASP of 13 December 2024 of the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez). The Technical Sanitary Regulation will enter into force six months after publication in the Official Journal. Text available from: Ministerio de Producción, Comercio Exterior, Inversiones y Pesca (Ministry of…
Regular notificationG/TBT/N/ECU/546
Comment deadline: Closed on 9 November 2024
Proyecto 'Normativa Técnica Sanitaria sustitutiva para la vigilancia y control de la publicidad y G/TBT/N/ECU/546 - 2 - promoción de medicamentos en general, productos naturales procesados de uso medicinal, productos o medicamentos homeopáticos y dispositivos médicos' (Draft Substitute Sanitary Technical Regulation on the monitoring and control of the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical dev
The aim of the draft Substitute Sanitary Technical Regulation on the monitoring and control of the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices is to regulate, control and monitor the advertising and promotion of medicines in general, processed natural products for medicinal use, homeopathic products or medicines and medical devices, in accordance with the provisions of the Organic Law on Health, with a view to promoting and providing information on the rational use and proper handling of the above-mentioned products. Only products with a sanitary registration certificate classifying them as over-the-counter products may be advertised. The provisions set out in the notified draft Regulation are applicable and mandatory throughout the national territory for natural and legal persons, whether national or foreign, that are engaged in or disseminate advertising and/or promotion activities in establishments and through mass media; it concerns the products that are mentioned above and that have undergone the sanitary registration or notification in effect 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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