G/TBT/N/ECU/522  
12 December 2023  
(23-8505) 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 a uthority 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 or 2272  
Email:  
puntocontactoOTCECU@produccion.gob.ec ; 
puntocontactoECU@gmail.com ; 
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 
Sanitary Technical Regulations to grant exclusi vity for test data for pharmaceutical 
products containing new chemical entities.  
The notified draft Regulations establish the procedure by which the ARCSA grants a period 
of exclusivity for test data or other undisclosed information on safety and efficacy,  which 
require considerable effort to obtain, for pharmaceutical products containing new 
chemical entities, in accordance with the provisions of the Organic Code of the Social 
Economy of Knowledge, Creativity and Innovation (COESCI).  
5. Title, number of p ages and language(s) of the notified document : Proyecto de 
Normativa Técnica Sanitaria para otorgar exclusividad de datos de prueba de Productos 
Farmacéuticos que contengan nuevas entidades químicas  (Draft Sanitary Technical 
Regulations to grant exclusivity for test data for pharmaceutical products containing new 
chemical entities) (11 pages, in Spanish)  G/TBT/N/ECU/522  
- 2 - 
  6. Description of content : The notified draft Regulations establish the procedure by which 
the ARCSA grants a period of exclusivity for test data or other undisclosed information on 
safety and efficacy, which require considerable effort to obtain, for pharmaceutical 
products containi ng new chemical entities, in accordance with the provisions of the 
Organic Code of the Social Economy of Knowledge, Creativity and Innovation (COESCI).  
The notified Sanitary Draft Regulations are applicable to and binding on all natural and 
legal persons, whether domestic or foreign, governed by public or private law, that 
request a period of exclusivity for test data or other undisclosed information on safety 
and efficacy requiring, which require considerable effort to obtain, for pharmaceutical 
products c ontaining new chemical entities, as well as on all sanitary registration applicants 
requiring registration of a medicine containing a chemical entity within the previously 
mentioned period of exclusivity.  
7. Objective and rationale, including the nature o f 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 : To be determined  
Proposed date of entry into force : Six months afte r 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  
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 or 2272 
Email:  
puntocontactoOTCECU@produccion.gob.ec ; 
puntocontactoECU@gmail.com ; 
cyepez@produccion.gob.ec ; 
www.controlsanitario.gob.ec  
https://me mbers.wto.org/crnattachments/2023/TBT/ECU/23_14486_00_s.pdf