G/SPS/N/ECU/225  
19 September  2019 
(19-6019) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original:  Spanish  
 
  NOTIFICATION  
1. Notifying Member : ECUADOR  
If applicable, name of local government involved:  
2. Agency responsible : Agencia Nacional de Regulacion, Control y Vigilancia Sanitaria,  
ARCSA  (National Agency for Sanitary Regulation, Control and Surveillance)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO ; ICS numbers should be provided in addition, 
where applicable) : Natural proce ssed products for medicinal use  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document : Proyecto de Normativa técnica  sanitaria sustitutiva de 
registro sanitario de productos naturales procesados de uso medicinal, y de buenas 
prácticas de manufactura para laboratorios farmacéuticos de productos naturales 
procesados de uso medicinal  (Draft Substitute Sanitary Technical Re gulation on the 
sanitary registration of natural processed products for medicinal use, and good 
manufacturing practices for pharmaceutical laboratories working with natural processed 
products for medicinal use) Language(s) : Spanish Number of pages : 41 
Text available at:  
https://members.wto.org/crnattachments/2019/SPS/ECU/19_5034_00_s.pdf  
6. Description of content : Purpose:  
The notified Sanitary Technical Regulation see ks to establish quality, safety and efficacy 
parameters for the sanitary registration of natural processed products for medicinal use, 
and criteria for the promotion, control and monitoring of such products and the penalties 
relating to them.  
It establishe s the parameters for the operation, control and monitoring of, and penalties 
for, establishments that manufacture, store, distribute or market natural processed 
products for medicinal use.  
It also seeks to establish requirements and guidelines for delivery  of certificates of good 
manufacturing practices to domestic pharmaceutical laboratories that manufacture, 
process, package, store, distribute and transport natural processed products for medicinal 
use. 
Scope of application:  
The notified Regulation is binding on all natural or legal persons, whether domestic or 
foreign, who are required to register natural processed products for medicinal use for 
marketing in Ecuador, as well as natural or legal persons, whether domestic or foreign, 
who ar e responsible for manufacturing, importing, packaging or packing, transporting, 
storing, distributing or marketing natural processed products for medicinal use throughout 
the national territory.  G/SPS/N/ECU/225  
- 2 - 
  7. Objective and rationale : [X] food safety , [ ] animal heal th, [ ] plant protection , [ ] 
protect humans from animal/plant pest or disease, [ ] protect territory from 
other damage from pests.  
8. Is there a relevant international standard ? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial number of Codex 
standard or related text) : 
[ ] World Organisation for Animal Health (OIE) (e.g. T errestrial or Aquatic 
Animal Health Code, chapter number) : 
[ ] International Plant Protection Convention ( e.g. ISPM No. ): 
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes [ ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:  
9. Other relevant documents and language(s) in which these are available:  
10. Proposed date of adoption (dd/mm/yy) : 13 November 2 019 
Proposed date of publication (dd/mm/yy) : 13 November 2 019 
11. Proposed date of entry into force : [ ] Six months from date of publication, and/or 
(dd/mm/y y): Upon publication in the Official Journal  
[ ] Trade facilitating measure  
12. Final date for comments : [X] Sixty days from the date of circulation of the 
notification and/or ( dd/mm/yy ): 18 November 2 019 
Agency or authority designated to handle comments : [ ] National Notification 
Authority, [ ] National Enquiry Point . Address, fax number and email address (if 
available) of other body:  
Agencia Nacional de Regulacion, Control y Vigilancia Sanitaria,  ARCSA (National Agency for 
Sanitary Regulation, C ontrol and Surveillance)  
Ciudadela Samanes, Av . Francisco de Orellana y Av . Paseo del Parque, Bloque 5  
Guayaquil - Ecuador  
Tel.: (+593 04) 3727 440  
Website: https://www.controlsanitario.gob.e c/ 
13. Text(s) available from : [ ] National Notification Authority, [ ] National Enquiry 
Point . Address, fax number and email address (if available) of other body:  
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) 3948 760, Ext. 2254 - 2272 
Email:  puntocontactoOTCECU@produccion.gob.ec   
 puntocontactoOTCECU@gmail.com   
 aramon@produccion.gob.ec   
 cyepez@produccion.gob.ec   
 jsanchez@produccion.gob.ec   
Website: https://www.controlsanitario.gob.ec