  
  
G/TBT/N/ECU/514/Add.1  
5 January  2023 
(23-0109) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 4 January 2 023, is being circulated at the request of the 
delegation of Ecuador . 
 
_______________  
 
 
Title: REFORMA PARCIAL A LA NORMATIVA TÉCNICA SANITARIA SUSTITUTIVA DE BUENAS 
PRÁCTICAS DE MANUFACTURA PARA LABORATORIOS FARMACÉUTICOS  (Partial amendment to the 
Substitute Sanitary Technical Regulations on good manufacturing practices for pharmaceutical 
laboratories)  
 
Reason for Addendum:  
[ ] Comment period changed - date:  
[ ] Notified measure adopted - date:  
[ ] Notified measure published - date:  
[X] Notified measure enters into force - date: 5 June 2 023 
[ ] 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[ ] Notified measure withdrawn or revoked - date:  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:  
Partial amendment to the Substitute Sanitary Technical Regulations on good 
manufacturing practices for pharmaceutical laboratories  
https://members.wto.org/crnattachments/2023/TBT/ECU/23_0155_00_s.pdf  
 
Description : Partial amendment to the Substitute Sanitary Technical Regulations on good 
manufacturing practices for pharmaceutical laboratories  
 
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/514/Add.1  
- 2 - 
  By means of this Addendum No. 1, the Republic of Ecuador advises that the Partial amendment to 
the Substitute Sanitary Technical Regulations on good manufacturing practices for pharmaceutical 
laboratories has been issued pursuant to Resolution No. A RCSA -DE-2022-018-AKRG of 5 December 
2022 by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor 
Leopoldo Izquieta Pérez), in order to facilitate trade . The notified Sani tary Technical Regulations will 
enter into force six months after their signature, without prejudice to their 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  
PuntocontactoOTCECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
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