G/TBT/N/ECU/501/Add.2  
23 February  2022 
(22-1754) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 2 3 February 2 022, is being circulated at the request of the 
delegation of Ecuador . 
 
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Title: RESOLUCIÓN Nro . ARCSA -DE-2022-005-AKRG REFORMA PARCIAL A LA RESOLUCIÓN ARCSA -
DE-2021-006-AKRG MEDIANTE LA CUAL SE EXPIDE LA NORMATIVA TÉCNICA SANITARIA PARA LA 
REGULACIÓN Y CONTROL DE MEDICAMENTOS QUE CONTENGAN SUSTANCIAS CATALOGADAS 
SUJETAS A FISCALIZACIÓN  (Resolution ARCSA -DE-2022-005-AKRG : Partial Amendment to 
Resolution ARCSA -DE-2021-006-AKRG issuing the Sanitary Technical Regulation for the regulation 
and control of medicines containing controlled substances)  
 
Reason for Addendum:  
[ ] Comment period changed - date:  
[ ] Notified measure adopted - date:  
[ ] Notified measure published - date:  
[ ] Notified measure enters into force - date:  
[ ] 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[ ] Notified measure withdrawn or revoked - date:  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 
[X] Other: www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2022/TBT/ECU/22_1757_00_s.pdf  
 
Description : Resolution ARCSA -DE-2022-005-AKRG 
Partial Amendment to Resolution ARCSA -DE-2021-006-AKRG issuing the Sanitary Technical 
Regulation for the regulation and control of medicines containing controlled substances  
 
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/501/Add.2  
- 2 - 
  By means of this Addendum No. 2, the Republic of Ecuador advises that the Sanitary Technical 
Regulation for the regulation and control of medicines containing controlled substances has been 
issued pursuant to Resolution ARCSA -DE-2022-005-AKRG  of 10 February 2022 , the main purpose 
of which is to extend th e time frames established in the Regulation in order to facilitate trade , by 
the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo 
Izquieta Pérez) . The regulation will enter into force on the date of its signature, without prejudice to 
its 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  (Unde r-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@gma il.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
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