G/TBT/N/ECU/512  
17 March  2022 
(22-2350) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member: ECUADOR  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Agencia  Nacional de Regulacion, Control y Vigilancia Sanitaria,  ARCSA (National Agency 
for Sanitary Regulation, Control and Surveillance)  
Ciudadela Samanes, Av. Francisco de Orellana y Av. Paseo del Parque. Bloque 5, 
Guayaquil - Ecuador  
Tel.: (+593 -4) 3727 440  
Website: https://www.controlsanitario.gob.ec  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding  the notification shall be indicated if different from above:  
Subsecretaría de Calidad  (Under -Secretariat for Quality)  
Ministerio de Producción, Comercio Exterior, Inversiones y Pesca , MPCEIP (Ministry of 
Production, Foreign Trade, Investment and Fisheries ) 
Address: Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, 
Bloque amarillo  
Tel.: (+593 -2) 3948760, Ext. 2254 - 2272 
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
Website: www.produccion.gob.ec  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading.  ICS numbers may be provided in addition, where applic able): The 
notified regulation is the draft Amendment to the Sanitary Technical Regulation 
establishing the criteria and requirements for demonstrating bioequivalence and 
bioavailability in medicines for human use and consumption (Resolution ARCSA -DE-015-
2018-JCGO).  
5. Title, number of pages and language(s) of the notified document:  PROYECTO DE 
REFORMA A LA NORMATIVA TÉCNICA SANITARIA QUE ESTABLECE LOS CRITERIOS Y 
REQUISITOS PARA DEMOSTRAR BIOEQUIVALENCIA Y BIODISPONIBILIDAD, EN LOS 
MEDICAMENTOS DE USO Y CONSUMO HUMANO, RESOLUCIÓN ARCSA -DE-015-2018-
JCGO  (Draft Amendment to the Sanitary Technical Regulation establishing the criteria and 
requirements for demonstrating bioequivalence and bioavailability in medicines for human 
use and con sumption (Resolution ARCSA -DE-015-2018-JCGO)) (10 pages, in Spanish)  G/TBT/N/ECU/512  
- 2 - 
  6. Description of content: The notified regulation is the draft Amendment to the Sanitary 
Technical Regulation establishing the criteria and requirements for demonstrating 
bioequivalence  and bioavailability in medicines for human use and consumption 
(Resolution ARCSA -DE-015-2018-JCGO).  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Consumer information, labelling; Prevention of deceptive practices a nd 
consumer protection; Protection of human health or safety  
8. Relevant documents:  
- 
9. Proposed date of adoption: 60 days from notification or thereafter  
Proposed date of entry into force: 180 days from the date of adoption  
10. Final date for comments: 60 days from notification  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Contact and/or national enquiry point:  
Subsecretarí a de Calidad  
Ministerio de Producción, Comercio Exterior, Inversiones y Pesca (MPCEIP)  
 
Address: Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, 
Bloque amarillo  
 
Tel.: (+593 -2) 3948760, Ext. 2254 - 2272 
 
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
 
www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2022/TBT/ECU/22_2289_00_s.pdf  
https://members.wto.org/crnattachments/2022/TBT /ECU/22_2289_01_s.pdf