G/TBT/N/ECU/513  
5 May 2022 
(22-3513) 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, Invest ment 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 [ ], 3.2 [ ], 7.2 [ ], 
other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : The 
notified regulations are the draft "Substitute Sanitary Technical Regulations for the 
Substitute Regulation s on Sanitary Registration for Medicines in General", which will 
replace the "Substitute Regulation s on Sanitary Reg istration for Medicines in General ", 
issued by Ministerial Decision No. 586. 
5. Title, number of pages and language(s) of the notified document : Proyecto 
Normativa Técnica Sanitaria Sustitutiva del Reglamento Sustitutivo de Registro Sanitario 
para Medicamentos en General  (Draft Substitute Sanitary Technical Regulations for the 
Substitute Regulations on Sanitary Registration for Medicines in General) (39 pages, in 
Spanish)  G/TBT/N/ECU/513  
- 2 - 
  6. Description of content : Draft Substitute Sanitary Technical Regulations fo r the 
Substitute Regulation s on Sanitary Registration for Medicines in General  
The notified regulations are the draft "Substitute Sanitary Technical Regulations for the 
Substitute Regulation s on Sanitary Registration for Medicines in General", which will 
replace the "Substitute Regulation s on Sanitary Registration for Medicines in General ", 
issued by Ministerial Decision No. 586. The purpose of these Technical Regulations is to 
establish the legal and technical requirements that ensure quality, safety and efficacy, 
under which the Sanitary Registration Certificate will be granted to medicines in general 
for human use and consumption , as well as  the criteria for the control and surveillance of  
such medicines.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Consumer information, 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  
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Contact and/or national enquiry point:  
Subsecretaría 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_3231_00_s.pdf