G/TBT/N/ECU/514  
6 July 2022 
(22-5190) 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, Invest ment and Fisheries)  
Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, Bloque 
amarillo  
Tel.: (+593 -2) 3948760, Ext. 2254 - 2272 
Email:  
puntocontactoOTCECU@produccion.gob.ec ; 
puntocontactoECU@gmail.com  
jmarino@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 to the Substitute Sanitary Technical Regulations on good 
manufacturing practices for pharm aceutical laboratories, which seek to establish the 
requirements and guidelines for granting the certificate of good manufacturing practices 
to domestic and foreign pharmaceutical laboratories applying for sanitary registration in 
Ecuador that manufacture,  process, package, store, distribute and transport medicines in 
general, medicines containing controlled substances, biological products, 
radiopharmaceuticals, active pharmaceutical ingredients and products undergoing 
research.  
5. Title, number of pages a nd language(s) of the notified document : Proyecto de 
reforma parcial a la Normativa Técnica Sanitaria sustitutiva de Buenas Prácticas de 
Manufactura para laboratorios farmacéuticos  (Draft partial amendment to the Substitute G/TBT/N/ECU/514  
- 2 - 
  Sanitary Technical Regulations o n good manufacturing practices for pharmaceutical 
laboratories) (36 pages, in Spanish)  
6. Description of content : Draft partial amendment to the Substitute Sanitary Technical 
Regulations on good manufacturing practices for pharmaceutical laboratories, which seek 
to establish the requirements and guidelines for granting the certificate of good 
manufacturing practices to domestic and foreign pharmaceutical laboratories applying for 
sanitary registration in Ecuador that manufacture, process, package, store, distribute and 
transport medicines in general, medicines containing controlled substances, biological 
products, radiopharmaceuticals, active pharmaceutical ingredients and products 
undergoing research.  
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. Relevant documents:  
- 
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : The notified Sanitary Technical Regulations will 
enter into force six months after their signature, without prejudice to their publication in 
the Official Journal.  
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 Qu ality) 
Ministerio de Producción, Comercio Exterior, Inversiones y Pesca , MPCEIP (Ministry of 
Production, Foreign Trade, Investment and Fisheries)  
Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, Bloque 
amarillo  
Tel.: (+593 -2) 394 8760, Ext. 2254 - 2272 
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2022/TBT/ECU/22_4509_00_s.pdf