G/TBT/N/ECU/475  
29 August  2019 
(19-5563) 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 Regulación, 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) 04 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 
regard ing 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 Fisher ies) 
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  
aramon@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchez@produccion.gob.ec  
Website: www.industrias.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) : 
(ICS: 11.100)  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Normativa técnica sanitaria sustitutiva de registro sanitario de productos naturales 
procesados de uso medicinal, y de buenas prácticas de manufactura para laboratorios 
farmacéuticos de productos naturales procesados de uso medicinal  (Draft Substitute 
Sanitary Technical Regulation on the sanitary registration of natural processed products 
for medicinal use and good manufacturing practices for pharmaceutical laboratories 
working with natural processed products for medicinal use). (41 p ages, in Spanish)  G/TBT/N/ECU/475  
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  6. Description of content:  
Purpose:  
The purpose of the notified Sanitary Technical Regulation is to establish quality, safety 
and efficacy parameters for the sanitary registration of natural processed products for 
medicinal use and crite ria for the promotion, 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 n atural processed 
products for medicinal use.  
It also seeks to establish requirements and guidelines for delivery of certificates of Good 
Manufacturing Practices to domestic pharmaceutical laboratories that manufacture, 
process, package, store, distribute a nd transport natural processed products for medicinal 
use. 
Scope:  
The notified regulation is binding on all natural or legal persons, whether domestic or 
foreign, who need to register natural processed products for medicinal use for marketing 
in Ecuador, a s well as natural or legal persons, whether domestic or foreign, who are 
responsible for manufacturing, importing, packaging or packing, transporting, storing, 
distributing and marketing natural processed products for medicinal use throughout the 
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 ; Quality requirements  
8. Relevant documents:  
Normative references:  
1. La Ley Orgánica de Salud y su Reglamento ; 
2. United States Pharmacopeia, National Formulary of the United States of America, 
British Pharmacopoeia, International Pharmacopoeia, European Pharmacopoeia,  
French Codex, Royal Spanish Pharmacopoeia, British Herbal Pharmacopoeia, 
Brazilian Pharmacopoeia, Pharmacopoeia of the People's Republic of China, 
TRAMIL Pharmacopoeia and others that the ARCSA deems necessary and that 
include natural products;  
3. Regulation s: General Regulations of the United States Food and Drug 
Administration (FDA), World Health Organization (WHO) technical reports, 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH) g uides, and others that the 
domestic sanitary authority deems necessary ; Monographs on safety and efficacy 
published by the WHO or by the European Scientific Cooperative on Phytotherapy 
(ESCOP), or others that the domestic sanitary authority deems relevant;  
4. Current national pharmacological standards ; and 
5. WHO quality control standards for medicinal plants and national technical 
standards on quality control for natural products.  
Notification history:  
1. G/TBT/N/ECU/326  
2. G/TBT/N/ECU/326/Add.1  
9. Proposed date of adoption : 60 days from notification or thereafter  
Proposed date of entry into force : Upon publication in the Official Journal.  G/TBT/N/ECU/475  
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  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:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoOTCECU@gmail.com  
aramon@produccion. gob.ec  
cyepez@produccion.gob.ec  
jsanchez@produccion.gob.ec  
https://www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2019/TBT/ECU/19_4769_00_s.pdf