   
  
IP/N/1/CHL/19  
IP/N/1/CHL/U/3   
29 September 2023  
(23-6523) Page: 1/2 
Council for Trade -Related Aspects  
of Intellectual Property Rights  Original: Spanish  
 
  
NOTIFICATION OF LAWS AND REGULATIONS  
UNDER ARTICLE 63.2 OF THE TRIPS AGREEMENT  
CHILE: DECREE  NO. 3 APPROVING THE REGULATIONS FOR THE NATIONAL CONTROL  
SYSTEM FOR PHARMACEUTICAL S FOR HUMAN USE  
Notifying Member  CHILE 
 
Details of the notified legal text  
 
Title DECREE NO. 3 APPROVING THE REGULATIONS FOR THE NATIONAL 
CONTROL SYSTEM FOR PHARMACEUTICAL S FOR HUMAN USE  
Subject matter  Protection of undisclosed information  
Nature of 
notification  [  ] Main dedicated intellectual property law or regulation  
[X] Other law or regulation  
Link to legal text* https://ip -documents.info/2023/IP/CHL/23_12416_00_s.pdf  
Notification status  [  ] First notification  
[X] Amendment or revision to notified legal text  
[  ] Replacement or consolidation of notified legal text(s)  
Previous 
notification(s) 
referred to  IP/N/1/CHL/U/1   
Brief description of the notified legal text  
 
The Decree governs the requirements, control, and quality oversight of pharmaceutical products, 
as well as the authorization requirements for laboratories, and sanitary registration procedures, 
among others.   
 
Language(s) of 
notified legal text  Spanish  
Entry into force  25 June 2011  
Other date  Enactment: 25 January 2010  
 
Notification details  
 
Submission date 
of notification  2 June 2023  IP/N/1/CHL/19 • IP/N/1/CHL/U/3  
 
- 2 - 
 
  Other information    
Agency or 
authority 
responsible  Ministry of Health - Undersecretariat for Public Health  
 
 
*Links are provided to texts of laws and regulations notified under the TRIPS Agreement in the form 
supplied by the Member concerned; the WTO Secretariat does not endorse or revise their content.  