G/TBT/N/ECU/509  
5 October  2021 
(21-7485) 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:  
puntocontacto -OTCECU@produccion.gob.ec  
puntocontactoECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
Website: www.industrias.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 Substitute Technical Regulation to auth orize the exceptional 
importation and importation for the purposes of donation of medicines, biological 
products, medical devices and biochemical and diagnostic reagents  
5. Title, number of pages and language(s) of the notified document:  Reforma Parcial 
a la Normativa Técnica Sustitutiva para autorizar la importación por excepción e 
importación por donación de Medicamentos, Productos Biológicos, Dispositivos Médicos y 
Reactivos Bioquímicos y de Diagnóstico  (Partial Amendment to the Substitute Tech nical 
Regulation to authorize the exceptional importation and importation for the purposes of 
donation of medicines, biological products, medical devices and biochemical and 
diagnostic reagents) (8 pages, in Spanish)  G/TBT/N/ECU/509  
- 2 - 
  6. Description of content: Partial Amendment to the Substitute Technical Regulation to 
authorize the exceptional importation and importation for the purposes of donation of 
medicines, biological products, medical devices and biochemical and diagnostic reagent s. 
Document for trade facilitation.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Prevention of deceptive practices and consumer protection; Protection of 
human health or safety  
8. Relevant documents:  
- 
9. Proposed date of adoption: 10 September 2021  
Proposed date of entry into force: 10 September 2021; The notified Resolution shall 
enter into force on the date of its signature, without prejudice to its publication in the 
Official Journal. Resolution ARCSA -DE-2021-013-AKRG was issued and signed on 10 
September 2021.  
10. Final date for comments: Not applicable  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other bod y: 
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  
puntocontactoECU@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_6334_00_s.pdf