G/TBT/N/ECU/511/Add.1  
20 June 2022 
(22-4761) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 2 0 June 2 022, is being circulated at the request of the 
delegation of Ecuador . 
 
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Title: Proyecto de Normativa Técnica Sanitaria para la aprobación de ensayos clínicos y la 
certificación de productos de uso y consumo humano y sus establecimientos, durante emergencias 
sanitarias o situaciones de emergencia, nacionales o internacionales  (Draft Sanitary Technical 
Regulation for the approval of clinical trials and t he certification of products for human use and 
consumption and their establishments, during health emergencies or national or international 
emergency situations).  
 
Reason for Addendum:  
[ ] Comment period changed - date:  
[ ] Notified measure adopted - date:  
[ ] Notified measure published - date:  
[X] Notified measure enters into force - date: 30 May 2 022 
[ ] Text of final measure available from1: 
[ ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:  
[ ] Content or scope of notified measure changed and text available from1: 
New deadline for comments (if applicable):  
[ ] Interpretive guidance issued and text available from1: 
[X] Other:  
Draft Sanitary Technical Regulation for the approval of clinical trials and the certification 
of products for human use and consumption and their establishments, during health 
emergencies or national or international emergency situations.  
https://members.wto.org/crnattachments/2022/TBT/ECU/22_4175_00_s.pdf  
 
 
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/511/Add.1  
- 2 - 
  Description : Draft Sanitary Technical Regulation for  the approval of clinical trials and the 
certification of products for human use and consumption and their establishments, during health 
emergencies or national or international emergency situations.  
By means of this Addendum No. 1, the Republic of Ecuador  advises that the Sanitary Technical 
Regulation for the approval of clinical trials and the certification of products for human use and 
consumption and their establishments, during health emergencies or national or international 
emergence situations, has b een issued pursuant to Resolution ARCSA -DE-2022-008-AKRG of 1 0 May 
2022 by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor 
Leopoldo Izquieta Pérez), in order to facilitate trade . The notified measure will enter into eff ect on 
the date of its publication in the Official Journal (3 0 May 2 022).  
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  
PuntocontactoOTCECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@prod uccion.gob.ec  
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