G/TBT/N/ECU/501/Add.3  
9 May 2023 
(23-3273) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 9 May 2 023, is being circulated at the request of the delegation 
of Ecuador . 
 
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Title: 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  (Partial Amendment to 
Resolution ARCSA -DE-2021-006-AKRG issuing the Sanitary Technical Regulation for the regula tion 
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[ ] Notified measure withdrawn or revoked - date:  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 from1: 
[X] Other:  
www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2023/TBT/ECU/23_09547_00_s.pdf  
 
Description : 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.3  
- 2 - 
  By means of this Addendum No. 3, the Republic of Ecuador advises that the Sanitary Technical 
Regulation for the regulation and control of medicines containin g controlled substances . The main 
purpose of Resolution ARCSA -DE-2023-008-AKRG is to exclude medicines that contain chemical 
precursors and specific chemical substances from certain control measures, based on the health risk 
and the risk of diversion for illicit uses of these medicines, in order to facilitate trade.  
The Regulation has been issued pursuant to Resolution No. A RCSA -DE-2023-008-AKRG of 1 1 April 
2023 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  (Ministr y 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 Gesti ón 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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