G/TBT/N/ECU/515  
21 October  2022 
(22-7901) Page: 1/3 
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 
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, Invest ment and Fisheries)  
Address : Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, 
Bloque amarillo  
Tel.: (+593 -2) 3948760, Ext. 2254 or 2272  
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@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 [ ], 3.2 [ ], 7.2 [ ], 
other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : Draft 
Substitute Sanitary Technical Regulation on the sanitary certification of homeopathic 
products or medicines and good manufacturing practices for homeopathi c pharmaceutical 
laboratories, the purpose of which is to establish the quality, safety and efficiency 
parameters for granting sanitary certification to homeopathic products or medicines . The 
notified text also lays down the criteria for the promotion, adv ertising, control and 
monitoring of such products and the penalties relating to them.  
It establishes the parameters for the operation, control and monitoring of, and penalties 
for, establishments that manufacture, store, distribute or market homeopathic pr oducts 
or medicines.  
In addition, it seeks to establish requirements and guidelines for delivery of the certificate 
of good manufacturing practices to domestic pharmaceutical laboratories that 
manufacture, pack, store, distribute and transport homeopathic products or medicines.  G/TBT/N/ECU/515  
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  The notified Sanitary Technical Regulation is binding on all natural or legal persons, 
whether domestic o r foreign, that are required to register, re -register, modify or cancel 
homeopathic products or medicines for marketing in Ecuad or. It is also binding on natural 
or legal persons, whether domestic or foreign, that are responsible for manufacturing, 
importing, packing or packaging, transporting, storing, distributing or marketing 
homeopathic products or medicines in national territo ry. 
5. Title, number of pages and language(s) of the notified document : PROYECTO 
"NORMATIVA TÉCNICA SANITARIA SUSTITUTIVA DE NOTIFICACIÓN SANITARIA DE 
PRODUCTOS O MEDICAMENTOS HOMEOPÁTICOS, Y DE BUENAS PRÁCTICAS DE 
MANUFACTURA PARA LABORATORIOS FARMACÉUTICOS HOMEOPÁTICOS"  (Draft 
Substitute Sanitary Technical Regulation on the sanitary certification of homeopathic 
products or medicines and good manufacturing practices for homeopathic pharmaceutical 
laboratories) (34 pages, in Spanish)  
6. Description of content : Draft Substitute Sanitary Technical Regulation on the sanitary 
certification of homeopathic products or medicines and good manufacturing practices for 
homeopathic pharmaceutical laboratories, the purpose of which is to establis h the quality, 
safety and efficiency parameters for granting sanitary certification to homeopathic 
products or medicines . The notified text also lays down the criteria for the promotion, 
advertising, control and monitoring of such products and the penaltie s relating to them.  
It establishes the parameters for the operation, control and monitoring of, and penalties 
for, establishments that manufacture, store, distribute or market homeopathic products 
or medicines.  
In addition, it seeks to establish requiremen ts and guidelines for the delivery of the 
certificate of good manufacturing practices to domestic pharmaceutical laboratories that 
manufacture, pack, store, distribute and transport homeopathic products or medicines.  
The notified Sanitary Technical Regulat ion is binding on all natural or legal persons, 
whether domestic o r foreign, that are required to register, re -register, modify or cancel 
homeopathic products or medicines for marketing in Ecuador . It is also binding on natural 
or legal persons, whether domestic or foreign, that are responsible for manufacturing, 
importing, packing or packaging, transporting, storing, distributing or marketing 
homeopathic products or medicines in national territory.  
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 : 1 March 2 023; Six months after publication in the Official 
Journal  
Proposed date of entry into force : Six months after adoption  
10. Final date for comments : 60 days from notification  G/TBT/N/ECU/515  
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  11. Texts available from : National enquiry p oint [ ] 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 or 2272  
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2022/TBT/ECU/22_7124_00_s. pdf