G/TBT/N/ECU/501  
31 March  2021 
(21-2699) 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:  
Ciudadela Samanes, Av . Francisco de Orellana y Av . Paseo del Parque, Bloque 5  
Guayaquil - Ecuador  
Tel.: (+593 -4) 3727 440  
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 Producció n, 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 - 2272 
Email:  
puntocontacto -otcecu@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 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:  
4. Products covered (HS or CCCN where applicable, othe rwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : The 
purpose of the notified Sanitary Technical Regulation is to regulate and control medicines 
containing controlled substances (narcotics, psychotropics, chemical p recursors and 
specific chemical substances) . 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 produce, import, export, store, market, distribute  and dispense medicines 
containing controlled substances (narcotics, psychotropics, chemical precursors and 
specific chemical substances) ; with the exception of the dispensing, destruction, transfer, 
donation an d notification of claims of such medicines in  pharmacies operating in public 
and private health services . The notified Sanitary Technical Regulation does not apply to 
products for human use and consumption that contain in their formulation non -
psychoactive cannabis or hemp, or the derivatives thereof , which shall be regulated in 
accordance with the regulations for products for human use and consumption containing 
non-psychoactive cannabis or hemp that the Agency may establish for such purpose.  G/TBT/N/ECU/501  
- 2 - 
  5. Title, number of pages and language(s) of the notified document : PROYECTO DE 
NORMATIVA TÉCNICA SANITARIA PARA LA REGULACIÓN Y CONTROL DE MEDICAMENTOS 
QUE CONTENGAN SUSTANCIAS CATALOGADAS SUJETAS A FISCALIZACIÓN  (Draft 
Sanitary Technical Regulation for the regulation and control of medicines containing  
controlled substances) (48 pages, in Spanish)  
6. Description of content : The purpose of the notified Sanitary Technical Regulation is to 
regulate and control medicines containing controlled substances (narcotics, 
psychotropics, chemical precursors and sp ecific chemical substances).  
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 produce, import, 
export, store, market, distribute and dispense me dicines containing controlled substances 
(narcotics, psychotropics, chemical precursors and specific chemical substances) ; with 
the exception of the dispensing, destruction, transfer, donation an d notification of claims 
of such medicines in pharmacies oper ating in public and private health services.  
The notified Sanitary Technical Regulation does not apply to products for human use and 
consumption that contain in their formulation non -psychoactive cannabis or hemp, or the 
derivatives thereof, which shall be  regulated in accordance with the regulations for 
products for human use and consumption containing non -psychoactive cannabis or hemp 
that the Agency may establish for such purpose.  
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 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 available, 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 Fisheries)  
Address : Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, 
Bloque amarillo  
Tel.: (+593 -2) 3948760, Ext. 2254 - 2272 
Email:  
puntocontacto -otcecu@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/T BT/ECU/21_2404_00_s.pdf