G/TBT/N/ECU/500  
18 February  2021 
(21-1392) 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 
regardi ng 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 Fisheri es) 
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 ; puntocontactoECU@gmail.com ; 
jmarino@produccion.gob.ec ; cyepez@produccion.gob.ec ; jsanchezc@produccion.gob.ec  
Website: www.produccion.gob.ec  
3. Notified under Article 2.9.2 [ ], 2.10.1 [X], 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 
purpose of the notified Sanitary T echnical Regulation is to regulate and control finished 
products, the formulas of which contain non -psychoactive cannabis or hemp for human 
use and consumption, or derivatives thereof, used as raw materials in the production of 
pharmaceutical products . The provisions laid down in the notified Sanitary Technical 
Regulation are applicable to all national or foreign natural or legal persons based in 
Ecuador that prepare, package, pack, import, export, store, market, distribute, dispense 
and/or sell finished pr oducts, the formulas of which contain non -psychoactive cannabis or 
hemp for human use and consumption, or derivatives thereof, used as raw materials in 
the production of pharmaceutical products.  
5. Title, number of pages and language(s) of the notified do cument : Normativa 
Técnica Sanitaria para la regulación y control de productos terminados de uso y consumo 
humano que contengan cannabis no psicoactivo o cáñamo, o derivados de cannabis no 
psicoactivo o cáñamo  (Technical Sanitary Regulation for the regulation and control of G/TBT/N/ECU/500  
- 2 - 
  finished products for human use and consumption containing non -psychoactive cannabis 
or hemp, or derivatives thereof) (24 pages, in Spanish)  
6. Description of content : The purpose of the notified Sanitary Technical Regulation is to 
regulate and control finished products, the formulas of which contain non -psychoactive 
cannabis or hemp for human use and consumption, or derivatives thereof, used as raw 
materials in the production of pharmaceu tical products.  
The provisions laid down in the notified Sanitary Technical Regulation are applicable to all 
national or foreign natural or legal persons based in Ecuador that prepare, package, pack, 
import, export, store, market, distribute, dispense and/ or sell finished products, the 
formulas of which contain non -psychoactive cannabis or hemp for human use and 
consumption, or derivatives thereof, used as raw materials in the production of 
pharmaceutical products.  
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 10 February 2 021 
Proposed date of entry into force : 10 February 2 021: The notified Technical Sanitary 
Regulation will enter into force once approved by the highest authority of the Agency, 
without prejudice to its publication in the Official Journal . The Resolution was issued and 
approved on 1 0 February 2 021. 
10. Final date for comments : Ecuadorian legislation lacks a clear body of law exclusively 
dealing with the preparation, packaging or packing, importation, exportation, storage, 
marketing, distribution, dispensing and/or sale of products for human use and 
consumption containing non -psychoactive cannabis or hemp, or derivatives thereof, in 
their formulas . Since the entry into force of the Organic Law amending the Comprehensive 
Organic Penal Code, published in the Supplement  to Official Journal No. 107 of 2 4 
December 2 019, the Organic Law for the comprehensive prevention of the socio -economic 
phenomenon of drugs and the regulation and control of the use of designated controlled 
substances has excluded non -psychoactive cannabis or hemp, or derivatives thereof, from 
the list of controlled substances.  
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 - 2272 
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoECU@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_1227_00_s.pdf