G/TBT/N/ECU/510  
12 November  2021 
(21-8566) 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: 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 n otification 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 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, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : The 
purpose of the notified Sanitary Technical Regulation is to establish the procedure and 
requirements for authorizing the marketing in pack format of medicines in general, 
biological products, processed natural products for medicinal use and homeopathic 
products . It also lays down the procedure and requirements for authorizing the depletion 
of stocks of packaging, labels, package inserts and the finished product for medicines in 
general, biological products, processed natural products for medicinal use an d 
homeopathic products . The notifie d Sanitary Technical Regulation is binding for  holders  
of sanitary registration for medicines in general, biological products  and processed  natural  
products for medicinal use and for holders of sanitary notification for h omeopathic 
products who wish to market their products in pack format or need to deplete the stocks 
of their packaging, labels, package inserts or finished produ ct. G/TBT/N/ECU/510  
- 2 - 
  5. Title, number of pages and language(s) of the notified document : Proyecto de 
Normativa T écnica Sanitaria Sustitutiva para autorizar la comercialización bajo la 
modalidad de Pack y el agotamiento de existencias de envases, etiquetas, prospectos y 
del producto terminado de Medicamentos en general, productos Biológicos, productos 
Naturales Proce sados de Uso Medicinal y de Productos Homeopáticos  (Draft Substitute 
Sanitary Technical Regulation for authorizing the marketing in pack format of and the 
depletion of stocks of packaging, labels, package inserts and finished products for 
medicines in gene ral, biological products, processed natural products for medicinal use 
and homeopathic products) (15 pages, in Spanish)  
6. Description of content:  
The purpose of the notified Sanitary Technical Regulation is to establish the procedure 
and requirements for authorizing the marketing in pack format of medicines in general, 
biological products, processed natural products for medicinal use and homeopathic 
products. It also lays down the procedure and requirements for authorizing the depletion 
of stocks of packaging, labels, package inserts and the finished product for medicines in 
general, biological products, processed natural products for medicinal use and 
homeopathic products . 
The notifie d Sanitary Technical Regulation is binding for holders  of sanitary registration 
for medicines in general, biological products  and processed natural products for medicinal 
use and for holders of sanitary notification for homeopathic products who wish to market 
their products in pack format or need to deplete the  stocks of their packaging, labels, 
package inserts or finished produ ct. 
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 : 8 February 2 022 
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  
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:  
puntocontacto -otcecu@produccion.gob.ec  
puntocontactoecu@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produ ccion.gob.ec  
jsanchezc@produccion.gob.ec  
 
www.controlsanitario.gob.ec  
 
https://members.wto.org/crnattachments/2021/TBT/ECU/21_7116_00_s.pdf