G/TBT/N/ECU/511  
10 February  2022 
(22-1188) Page: 1/3 
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: 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 no tification 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:  
puntocontacto -OTCECU@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 applicable) : The 
purpose of this sanitary technical regulation is to establish guidelines for the process of 
approval of clinical trials for products in research and the certification of products for 
human use and consumption and of establishments subject to sanitary control and 
surveillance that come within the competence of ARCSA., during health emergencies or 
national or international emerg ency situations ; as well as the criteria for the sanitary 
control and surveillance thereof . This sanitary technical regulation is binding on all natural 
or legal persons, whether domestic or foreign, governed by public or private law, that 
request the appr oval of a clinical trial for a product in research or undertake the 
registration, re -registration or amendment of the sanitary certificate for products for 
human use and consumption ; and those that request the certification, extension, G/TBT/N/ECU/511  
- 2 - 
  amendment or renewal  of the certificate of good practices for establishments subject to 
sanitary control and surveillance that come within the competence of ARCSA, during 
health emergencies or national or international emergency situations.  
5. Title, number of pages and lang uage(s) of the notified document : Proyecto de 
Normativa Técnica Sanitaria para la aprobación de ensayos clínicos y la certificación de 
productos de uso y consumo humano y sus establecimientos, durante emergencias 
sanitarias o situaciones de emergencia, nac ionales o internacionales  (Draft Sanitary 
Technical Regulation for the approval of clinical trials and the certification of products for 
human use and consumption and their establishments, during health emergencies or 
national or international emergency si tuations ). (15 pages, in Spanish)  
6. Description of content : The purpose of this sanitary technical regulation is to establish 
guidelines for the process of approval of clinical trials for products in research and the 
certification of products for human u se and consumption and of establishments subject 
to sanitary control and surveillance that come within the competence of ARCSA., during 
health emergencies or national or international emergency situations ; as well as the 
criteria for the sanitary control a nd surveillance thereof.  
This sanitary technical regulation is binding on all natural or legal persons, whether 
domestic or foreign, governed by public or private law, that request the approval of a 
clinical trial for a product in research or undertake the  registration, re -registration or 
amendment of the sanitary certificate for products for human use and consumption ; and 
those that request the certification, extension, amendment or renewal of the certificate 
of good practices for establishments subject to  sanitary control and surveillance that come 
within the competence of ARCSA, during health emergencies or national or international 
emergency situations.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Consumer inform ation, labelling ; Prevention of deceptive practices and 
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  G/TBT/N/ECU/511  
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  11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
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:  
puntocontacto -otcecu@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_1543_00_s.pdf