G/TBT/N/ECU/510/Add.1  
17 March  2022 
(22-2351) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 1 7 March 2 022, is being circulated at the request of the 
delegation of Ecuador . 
 
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Title: Normativa Técnica Sanitaria Sustitutiva para autorizar la comercialización bajo la modalidad 
de Pack y el agotamiento de existencias de envases, etiquetas, prospectos y del producto terminado 
de Medicamentos en general, productos Biológicos, productos Naturales Procesados de Uso Medicinal 
y de Productos Homeopáti cos (Substitute Sanitary Technical Regulation for authorizing the 
marketing in pack format of and the depletion of stocks of packaging, labels, package inserts and 
finished products for medicines in general, biological products, processed natural products for 
medicinal use and homeopathic products)  
 
Reason for Addendum:  
[ ] Comment period changed - date:  
[ ] Notified measure adopted - date:  
[ ] Notified measure published - date:  
[X] Notified measure enters into force - date: 24 February 2 022; By means of this 
Addendum No. 1, the Republic of Ecuador advises that the Substitute Sanitary Technical 
Regulation for authorizing the marketing in pack format of and the depletion of stocks 
of packaging, labels, package inserts and finished products for me dicines in general, 
biological products, processed natural products for medicinal use and homeopathic 
products has been issued pursuant to Resolution ARCSA -DE-2022-002-AKRG of 3 1 
January 2 022 by the National Agency for Sanitary Regulation, Control and Surv eillance 
(ARCSA, Doctor Leopoldo Izquieta Pérez), in order to facilitate trade . The notified 
Regulation will enter into effect on the date of its publication in the Official Journal.  
[ ] 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[ ] Notified measure withdrawn or revoked - date:  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 from:1 
 
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/510/Add.1  
- 2 - 
  [X] Other: www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2022/TBT/ECU/22_2291_00_s.pdf  
 
Description : Substitute Sanitary Technical Regulation for authorizing the marketing in pack format 
of and the depletion of stocks of packaging, labels, package inserts and finished products for 
medicines in general, biological products, processed natural products for medicinal use and 
homeopathic products  
By means of this Addendum No. 1, the Repu blic of Ecuador advises that the Substitute Sanitary 
Technical Regulation for authorizing the marketing in pack format of and the depletion of stocks of 
packaging, labels, package inserts and finished products for medicines in general, biological 
products,  processed natural products for medicinal use and homeopathic products has been issued 
pursuant to Resolution ARCSA -DE-2022-002-AKRG of 3 1 January 2 022 by the National Agency for 
Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquiet a Pérez), in order to 
facilitate trade . The notified Regulation will enter into effect on the date of its publication in the 
Official Journal.  
Text available from : Ministerio de Producción, Comercio Exterior, Inversiones y Pesca  (Ministry of 
Production, Fo reign 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  
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