  
  
G/TBT/N/ECU/498/Add.2  
16 July 2021 
(21-5640) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 1 6 July 2 021, is being circulated at the request of the delegation 
of Ecuador . 
 
_______________  
 
 
Title: Substitute Sanitary Technical Regulation establishing guidelines for control of the traceability 
of medicines, biological products and medical devices  
 
Reason for Addendum:  
[ ] Comment period changed - date:  
[ ] Notified measure adopted - date:  
[ ] Notified measure published - date:  
[X] Notified measure enters into force - date: 21 June 2 021 
[X] Text of final measure available from1: 
www.controlsanitario.gob.ec/  
https://members.wto.org/crnattachments/2021/TBT/ECU/final_measure/21_4732_00
_s.pdf  
[ ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measur e 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: 
[ ] Other:  
 
Description : Partial amendment to the Sanitary Technical Regulation establishing guidelines for 
control of the traceability of medicines, biological products and medical devices, published in the 
Second Supplement to Official Journal No. 338 of 2 6 November 2 020 
The Repu blic of Ecuador refers to Addendum No. 1 corresponding to the partial amendment to the 
Sanitary Technical Regulation establishing guidelines for control of the traceability of medicines, 
 
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/498/Add.2  
- 2 - 
  biological products and medical devices, published in the Second Supp lement to Official Journal No. 
338 of 2 6 November 2 020. 
The partial amendment to the Sanitary Technical Regulation establishing guidelines for control of 
the traceability of medicines, biological products and medical devices has been issued pursuant to 
Resolution No. A RCSA -DE-003-2021-AKRG of 2 1 June 2 021 by the National Agency for Sanitary 
Regulation, Control and Surveillance (ARCSA) . This partial amendment will enter into force on 2 1 
June 2 021. 
Text available from : Ministerio de Producción, Comercio Exter ior, 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  
jsanchezc@produccion.gob.ec  
__________  