G/TBT/N/ECU/475/Rev.1  
23 October  2020 
(20-7368) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
Revision  
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) 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 
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, 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: puntoco ntacto -OTCECU@produccion.gob.ec ; puntocontactoOTCECU@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) : Laboratory 
medicine ( 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 pages, in Spanish)  G/TBT/N/ECU/475/Rev.1  
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  6. Description of content : Purpose : The notified Sanitary Technical Regulation seeks to 
establish quality, safety and efficacy parameters for the sanitary regis tration of natural 
processed products for medicinal use, and criteria 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 natural processed 
products for medicinal use.  
It also seeks to establish requirements and guidelines for delivery of certificates of good 
manufacturing practices to domestic pharmaceutical la boratories that manufacture, 
process, package, store, distribute and transport natural processed products for medicinal 
use. 
Scope of application : The notified Sanitary Technical Regulation is binding on all natural 
or legal persons, whether domestic or fo reign, who are required to register, re -register, 
modify or cancel natural processed products for medicinal use for marketing in Ecuador, 
as well as natural or legal persons, whether domestic or foreign, who are responsible for 
manufacturing, importing, pa ckaging or packing, transporting, storing, distributing or 
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 include natural products;  
3. Regulations : General Regulations of the United States Food and Drug 
Administration (FDA), World Health Organization (WHO) technical reports, 
International Confe rence on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH) guides, and others that the 
domestic sanitary authority deems necessary;  
4. 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;  
5. Current national pharmacological standards ; and 
6. WHO quality control standards for medicinal plants and national technical 
standards on quality control for natural products.  
Notification history : G/TBT/N/ECU/475  
9. Proposed date of adoption : 30 days from notification or thereafter  
Proposed date of entry into force : Six months from the date of adoption  
10. Final date for comments : 30 days from notification  G/TBT/N/ECU/475/Rev.1  
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  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 ; puntocontactoOTCECU@gmail.com ; 
jmarino@produccion.gob.ec ; cyepez@produccion.gob.ec ; jsanchezc@produccion.gob.ec  
www.normalizacion.gob.ec  
www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2020/TBT/ECU/20_6389_00_s.pdf