G/TBT/N/ECU/494  
5 January  2021 
(21-0124) 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 Regulación, Control y Vigilancia Sanitaria  - ARCSA (National Agency 
for Sanitary Regulation, Control and Surveillance), Doctor Leopoldo Izquieta Pérez  
Ciudadela Samanes, Av . Francisco de Orellana y Av . Paseo del Parque, Bloque 5, 
Guayaquil - Ecuador  
Tel.: (+593 -4) 3727440  
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 ent re Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, 
Bloque amarillo  
Tel.: (+593 -2) 3948760, Ext. 2254 - 2272 
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoOTCECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produ ccion.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) : The 
provisions established in the present draft regulation are applicable to all national or 
foreign natural or legal persons based in Ecuador  that prepare, package, import, export, 
store, market, distribute, dispense and/or sell pharmaceutical products, medical devices, 
processed foods, food supplements and cosmetic products that contain in their 
formulation non -psychoactive cannabis or hemp, o r the derivatives thereof.  
5. Title, number of pages and language(s) of the notified document : PROYECTO DE 
NORMATIVA TÉCNICA SANITARIA PARA LA REGULACIÓN Y CONTROL DE PRODUCTOS DE 
USO Y CONSUMO HUMANO QUE CONTENGAN CANNABIS NO PSICOACTIVO O CÁÑAMO , 
O SUS DERIVADOS (Draft Sanitary Technical Regulation for the regulation and control of 
products for human use and consumption containing non -psychoactive cannabis or hemp, 
or the derivatives thereof) (18 pages, in Spanish)  G/TBT/N/ECU/494  
- 2 - 
  6. Description of content : The purpose of the notified Sanitary Technical Regulation is to 
regulate and control pharmaceutical products, medical devices, processed foods, food 
supplements and cosmetic products that contain in their formulation non -psychoactive 
cannabis or hemp, or the derivatives thereof.  
The provisions established in the present draft regulation are applicable to all national or 
foreign natural or legal persons based in Ecuador that prepare, package, import, export, 
store, market, distribute, dispense and/or sell pharm aceutical products, medical devices, 
processed foods, food supplements and cosmetic products that contain in their 
formulation non -psychoactive cannabis or hemp, or the derivatives thereof.  
7. Objective and rationale, including the nature of urgent proble ms 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 av ailable, 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 Fisherie s) 
Address : 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  
puntocontactoOTCECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2021/TBT/ECU/21_0084_00_s.pdf