G/TBT/N/ECU/498  
11 January  2021 
(21-0359) 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: 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 Ex terior, 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  
puntocontactoOTCECU@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 
Sanitary Technical Regulation i s binding for all natural or legal persons, domestic or 
foreign, governed by public or private law, involved in the distribution chain for medicines, 
biological products or medical devices from their production or importation to their 
dispensation or deliv ery to the patient in pharmacies of the integrated public health 
network (RPIS), the complementary private health network (RPC) and private 
pharmacies . The Technical Regulation applies to all medicines, biological products or 
medical devices, whether domes tic or imported, marketed in the national territory that 
have undergone sanitary registration in Ecuador.  G/TBT/N/ECU/498  
- 2 - 
  5. Title, number of pages and language(s) of the notified document : Normativa 
Técnica Sanitaria sustitutiva que establece los lineamientos para el control de la 
trazabilidad de medicamentos, productos biológicos y dispositivos médicos  (Substitute 
Sanitary Technical Regulation establishing guidelines for control of the traceability of 
medicines, biological products and medical dev ices) (23 pages, in Spanish)  
6. Description of content : The purpose of this Sanitary Technical Regulation is to establish 
guidelines for the implementation, monitoring and control of the traceability of medicines, 
biological products and medical devices i n the country.  
The Sanitary Technical Regulation is binding for all natural or legal persons, domestic or 
foreign, governed by public or private law, involved in the distribution chain for medicines, 
biological products or medical devices from their produc tion or importation to their 
dispensation or delivery to the patient in pharmacies of the integrated public health 
network (RPIS), the complementary private health network (RPC) and private 
pharmacies.  
The Technical Regulation applies to all medicines, bio logical products or medical devices, 
whether domestic or imported, marketed in the national territory that have undergone 
sanitary registration in Ecuador.  
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 : 26 November 2 020 
Proposed date of entry into force : 25 May 2 021; 180 da ys after publication in the 
Official Journal.  
10. Final date for comments : The Regulation has been issued pursuant to Resolution No. 
ARCSA -DE-030-2020-MAFG of 1 7 November 2 020 by the National Agency for Sanitary 
Regulation, Control and Surveillance (ARCSA), and published in the Second Supplement 
to Official Journal No. 338 of 2 6 November 2 020. The authority responsible for this 
Regulation is the National Agency for Sanitary Regulation, Control and Surveillance 
(ARCSA).  
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:  
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 
www.controlsanitario.gob.ec  
 
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoOTCECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
https://members.wto. org/crnattachments/2021/TBT/ECU/21_0337_00_s.pdf