G/TBT/N/ECU/326  
3 May 2016  
(16-2487)  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 governme nt involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Agencia Nacional de Regulacion, Control y Vigilancia Sanitario , ARCSA (National Sanitary 
Regulation, Control and Surveillance Agency) Ciudadela Samanes, Av. Francisco de Ore llana y Av. Paseo del Parque. Bloque 5 
Tel./Fax: (+593-4) 3727 440 
Email: PuntocontactoOTCECU@mipro.gob.ec  
Website: http://www.normalizacion.gob.ec/  
Name and address (including telephon e 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 la Calidad (Under-Secretariat for Quality) 
Ministerio de Industrias y Productividad , MIPRO (Ministry of Industry and Productivity) 
Address: Yánez Pinzón N26-12, entre Av. Colón y La Niña Quito, Ecuador Tel.: (+593-2) 3948 760, Ext. 2358 or 2253 
Email: PuntocontactoOTCECU@mipro.gob.ec , mmartinez@mipro.gob.ec  
Website: http://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): 
3006700000 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
normativa técnica sanitaria sustitutiva para la obtención del registro sanitario y control de 
productos naturales procesados de uso medicina l, y de los establecimientos en donde se 
fabrican, almacenan, distribuyen y comercializan  (Draft Substitute Sanitary Technical 
Regulation on the sanitary registration and control of natural processed products for 
medicinal use, and of establishments that ma nufacture, store, distribute or market such 
products) (25 pages, in Spanish)  
6. Description of content: The draft notified Technical Regu lation covers the following: 
Purpose and scope; Definitions and abbreviations; Sanitary registration; Obtaining sanitary registration; Evaluation of therapeutic indi cations; Packaging, labelling and package 
inserts; Re-registration and changes to sanitary registration; Other authorizations; 
Importation; Marketing and promotion; Operating permits for pharmaceutical establishments relating to natural processed products for medicinal use; Monitoring and control; and Penalties. G/TBT/N/ECU/326 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable: The notified Sanitary Technical Regulation establishes the parameters of 
quality, safety and effectiveness for the sanita ry registration of natural processed products 
for medicinal use, and the criteria for the promotion, control and monitoring of such products. 
It also 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. 
The application of the notified Sanitary Technical Regulation is mandatory for natural and 
legal persons, whether domestic or foreign, who are responsible for manufacturing, 
importing, storing, distributing or marketin g natural processed products for medicinal use 
throughout the national territory.  
8. Relevant documents:  
1. Publication where notice appears: http://www.industrias.gob.ec// , 
http://www.controlsanitario.gob.ec/  
2. Proposal and basic document: Proyecto de normativa técnica sanitaria sustitutiva 
para la obtención del registro sanitario y control de productos naturales procesados 
de uso medicinal, y de los establecimientos en donde se fabrican, almacenan, 
distribuyen y comercializan  (Draft Substitute Sanitary Technical Regulation on the 
sanitary registration and control of natural processed products for medicinal use, and of establishments that manufacture, store, distribute or market such products) 
3. Publication in which Technical Regulation will be published when adopted: Registro 
Oficial  (Official Journal). 
9. Proposed date of adoption: 90 days from 29 April 2016. 
Proposed date of entry into force: 180 days from date of adoption.  
10. Final date for comments: 28 July 2016 
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresse s, if available, of other body:  
Contact and/or National Enquiry Point: 
Marlon Martínez 
Subsecretaría de la Calidad Ministerio de Industrias y Productividad, MIPRO 
Address: Yánez Pinzón N26-12, entre Av. Colón y La Niña 
Quito, Ecuador Tel.: (+593-2) 3948 760, Ext. 2358 or 2253 Email: PuntocontactoOTCECU@mipro.gob.ec , mmartinez@mipro.gob.ec  
Website: http://www.industrias.gob.ec/