G/TBT/N/ECU/498/Rev.1  
22 June 2021 
(21-5092) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
Revision  
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 Regulación, Control y Vigilancia Sanitaria , ARCSA (National Agency 
for Sanitary Regulation, Control and Surveillance), Doctor Leopoldo Izquieta Pérez  
Ciudadela Samanes, Av . Francisco de Orellana y Av . Paseo del Parque . Bloque 5, 
Guayaquil - Ecuador  
Tel.: (+593 -4) 3727440  
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 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  
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) : Partial 
Amendment to the Sanitary Technical Regulation establishing guidelines for control of the 
traceability of medicines, biological products and medical devices, published in the Second 
Supplement to Official Journal No. 338 of 2 6 November 2 020 G/TBT/N/ECU/498/Rev.1  
- 2 - 
  5. Title, number of pages and language(s) of the notified document : Reforma parcial 
a la Normativa Técnica Sanitaria que establece los lineamientos para el control de la 
trazabilidad de medicamentos, productos biológicos y dispositivos médicos, publicada en 
segun do suplemento de Registro Oficial No. 338 de 26 de noviembre de 2020  (Partial 
Amendment to the Sanitary Technical Regulation establishing guidelines for control of the 
traceability of medicines, biological products and medical devices, published in the Sec ond 
Supplement to Official Journal No. 338 of 2 6 November 2 020) (10 pages, in Spanish)  
6. Description of content : The notified text partially amend s the Sanitary Technical 
Regulation establishing guidelines for control of the traceability of medicines, biological 
products and medical devices, 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).  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Consumer information, labelling ; Prevention of deceptive practices and 
consumer protection  
8. Relevant documents:  
9. Proposed date of adoption 19 May 2 021; The notified Resolution shall enter into force 
on the date of its signature, without prejudice to its publication in the Official Journal . The 
authority responsible for this regulation  is the ARCSA.  
Proposed date of entry into force : 19 May 2 021; The notified Resolution shall enter 
into force on the date of its signature, without prejudice to its publication in the Official 
Journal . The authority responsible for this regulation  is the  ARCSA.  
10. Final date for comments : The notified Resolution shall enter into force on the date of 
its signature, without prejudice to its publication in the Official Journal . The authority 
responsible for this regulation is the 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:  
The authority responsible for this regulation is the ARCSA.  
 
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:  
puntocontacto -OTCECU@produccion.gob.ec  
puntocontactoOTCECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez @produccion.gob.ec  
jsanchezc@produccion.gob.ec  
 
www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2021/TBT/ECU/21_4265_00_s.pdf