G/TBT/N/ECU/498/Add.1  
18 February  2021 
(21-1390) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 1 8 February 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: 22 December 2 020 
[ ] 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[ ] Notified measure withdrawn or revoked - date:  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:  
https://members.wto.org/crnattachments/2021/TBT/ECU/21_1226_00_s.pdf  
 
Description : List of medicines, biological products and medical devices subject to traceability 
control, established by the Ministry of Public Health  
This Addendum No. 1 concerns the first transitional provision of Resolution ARCSA -DE-030-2020-
MAFG, published in the Second Supplement to Official Journal No. 338 of 26 November 2020. The 
Republic of Ecuador hereby advises that the list established by the national health authority in line 
with Official Circular MSP -SNPSI -2020-0262-O, approved by the National Under -Secretary for Health 
Promotion and Equality of the Ministry of Public Health, has been published . 
 
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.1  
- 2 - 
  The list of medicines, biological products and medical devices subject to traceability control, 
established by the Ministry of Public Health, has been issued pursuant to Resolution ARCSA -DE-033-
2020-MAFG of 1 December 2 020 by the Nation al Agency for Sanitary Regulation, Control and 
Surveillance (ARCSA)  and published in the Supplement to Official Journal No. 355 of 2 2 December 
2020. The notified Resolution enter ed into effect on the date of its publication in the Official Journal.  
The aut hority responsible for this Re gulation  is the National Agency for Sanitary Regulation, Control 
and Surveillance (ARCSA).  
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  
PuntocontactoECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
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