G/TBT/N/ECU/525  
12 April 2024 
(24-3108) 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 abov e: 
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 or 2272  
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoOTCECU@gmail.com  
palvarezc@produccion.gob.ec  
cyepez@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) : Draft 
partial amendment t o "Resolution ARCSA -DE-001-2019-JCGO issuing the guidelines for 
notifying the Sanitary Registry of general medicines and biological products"  
5. Title, number of pages and language(s) of the notified document : Reforma parcial 
a la Resolución ARCSA -DE-001-2019-JCGO por medio de la cual se expiden las directrices 
para realizar notificaciones al registro sanitario de medicamentos en general y productos 
biológicos  (Partial amendment to Resolution ARCSA -DE-001-2019-JCGO issuing the 
guidelines for notifying the Sanitary Registry of general medicines and biological 
products) ; (6 pages, in Spanish)  
6. Description of content : Draft partial amendment to "Resolution ARCSA -DE-001-2019-
JCGO issuing the guidelines for notifying the Sanitary Registry of general medic ines and 
biological products"  G/TBT/N/ECU/525  
- 2 - 
  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. Releva nt documents:  
Regulatory references:  
1. ISO 2859 -1:1999/Amd 1:2011, Sampling procedures for inspection by attributes . 
Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot -by-
lot inspection.  
2. ISO 12543 -1:2011, Glass in building - Laminated glass and laminated safety glass 
- Part 1 : Definitions and description of component parts.  
3. ISO/IEC 17025 :2017, General requirements for the competence of testing and 
calibration laboratories.  
4. ISO/IEC 17050 -1:2004, Conf ormity assessment - Supplier's declaration of 
conformity - Part 1 : General requirements.  
5. ISO/IEC 17067 :2013, Conformity assessment - Fundamentals of product 
certification and guidelines for product certification schemes.  
6. ISO 21690 :2006, Glass in building - Glass blocks - Specification and test 
methods;  
7. Ecuadorian Technical Standard NTE I NEN 1720  (1R):2017, Vidrios . Terminología.  
8. Ecuado rian Technical Standard NTE I NEN 2066 :1996, Vidrios de seguridad para 
edificaciones . Métodos de ensayo . 
9. Ecuadorian Technical Standard NTE I NEN 2067 :1996, Vidrios de seguridad para 
edificaciones . Requisitos.  
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : To be determined  
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  (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 or 2272  
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoOTCECU@gmail.com  
palvarezc@produccion.gob.ec  
cyepez@produccion.gob.ec  
Website: www.produccion.gob.ec  
www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2024/TBT/ECU/24_02601_00_s.pdf