G/TBT/N/CHL/673  
13 February  2024 
(24-1260) 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 : CHILE 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Ministerio de Salud , MINSAL (Ministry of Health)  
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 Relaciones Económicas Internacionales, SUBREI (Under -Secretariat for 
International Economic Relations)  - Ministerio de Relaciones Exteriores de Chile  (Ministry 
of Foreign Affairs of Chile)  
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) : Finished 
pharmace utical products  
5. Title, number of pages and language(s) of the notified document : Norma técnica : 
Guía de especificaciones de producto farmacéutico terminado  (Technical Standard : Guide 
to specifications for finished pharmaceutical products) (37 pages, in  Spanish)  
6. Description of content : The notified guide seeks to contribute to establishing a set of 
comprehensive specifications for pharmaceutical products . It provides guidance on 
establishing and justifying acceptance criteria, and selecting analytica l testing procedures 
for pharmaceutical products produced from active substances of synthetic or biological 
origin.  
Pursuant to Ministry of Health Supreme Decree  No. 3 of 2010, approving the Regulations 
of the National Control System for Products for Human  Use, the specifications are set out 
in a technical document that defines the attributes of a raw material, material, product, 
service or other, and determines which of their variables must be evaluated, describing 
all the tests, trials and analyses used t o determine and establish the acceptance or 
rejection criteria (Article  5(29)).  
As such, the specifications are critical quality standards that are proposed and justified 
by the manufacturer/registration holder, and approved by the Chilean Public Health 
Institute as compliance conditions.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health or safety ; Quality requirements  G/TBT/N/CHL/673  
- 2 - 
  8. Relevant documents:  
Decreto Supremo Nº 3 de 2010 del Ministerio de Salud, que Aprueba el Reglamento del 
Sistema Nacional de Control de Productos de Uso Humano.  
9. Proposed date of adoption : - 
Proposed date of entry into force : - 
10. Final date for comments : 60 days from notification  
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Subsecretaría de Relaciones Económicas Internacionales, SUBREI - Ministerio de 
Relaciones Exteriores de Chile  
Teatinos 180, piso 11  
Tel.: (+56) 2 2827 5250  
Email: tbt_chile@subrei.gob.cl  
https://www.minsal.cl/wp -content/uploads/2021/11/GUIA -EPT-Segunda -Edicion -Final-
V-29012024.pdf  
https://members.wto.org/crnattachments/2024/TBT/CHL/24_01445_00_s.pdf