G/TBT/N/ECU/504  
21 April 2021 
(21-3421) 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:  
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 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 am arillo 
Tel.: (+593 -2) 3948760, Ext. 2254 - 2272 
Email:  
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) : Proyecto 
de reforma parcial a la Normativa Técnica Sanitaria de Buenas Prácticas de 
Almacenamiento, Distribución y/o Transporte para establecimientos farmacéuticos y 
establecimientos de dispositivos médicos de uso humano  (Draft  Partial Amendment to the 
Sanitary Technical Regulation on good practices for storage, distribution and/or 
transportation for pharmaceutical establishments and establishments manufacturing 
medical devices for human use)  G/TBT/N/ECU/504  
- 2 - 
  5. Title, number of pages and langu age(s) of the notified document : Proyecto de 
reforma parcial a la Normativa Técnica Sanitaria de Buenas Prácticas de Almacenamiento, 
Distribución y/o Transporte para establecimientos farmacéuticos y establecimientos de 
dispositivos médicos de uso humano  (Draft Partial Amendment to the Sanitary Technical 
Regulation on good practices for storage, distribution and/or transportation for 
pharmaceutical establishments and establishments manufacturing medical devices for 
human use) (22 pages, in Spanish)  
6. Descr iption of content : Draft Partial Amendment to the Sanitary Technical Regulation 
on good practices for storage, distribution and/or transportation for pharmaceutical 
establishments and establishments manufacturing medical devices for human use.  
7. Objectiv e 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 [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 
Email:  
puntocontacto -otcecu@produccion.gob.ec  
puntocontactoecu@gmail.com  
jmarino@produccion.go b.ec 
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2021/TBT/ECU/21_2899_00_s.pdf