  
  
G/TBT/N/CHL/479/Add.1  
6 November  2023 
(23-7475) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 6 November 2 023, is being circulated at the request of the 
delegation of Chile. 
 
_______________  
 
 
Title: Proyecto que sustituye la Norma Técnica "Guía para la realización y presentación de estudios 
de estabilidad de productos farmacéuticos" (D.S Ex . Nº29/2012 del MINSAL)  (Draft replacing the 
Technical Standard "Guide to conducting and submitting stability studies for pharmaceutical 
products" (Ministry of Health Exempt Supreme Decree No. 29/2012))  
 
Reason for Addendum:  
[ ] Comment period changed - date:  
[ ] Notified measure adopted - date:  
[X] Notified measure published - date: 3 November 2 023 
[X] Notified measure enters into force - date: 3 November 2 025; the update of the technical 
standard approved by this Decree will come into force 24 months after its publication in 
the Official Journal.  
[X] Text of final measure available from1: 
Decreto exento número 48, de 2023. - Aprueba actualización norma técnica N°129, Guía 
para la Realización y Presentación de Estudios de Estabilidad de Productos 
Farmacéuticos e n Chile, y deja sin efecto decreto N°33 exento, de 2023.  
https://www.diariooficial.interior.gob.cl/publicaciones/2023/11/03/43691/01/2398633
.pdf 
Norma técnica N°129, Guía para la Realización y Presentación de Estudios de Estabilidad 
de Productos Farmacéuticos en Chile  
https://dipol.minsal.cl/wp -content/uploads/2023/11/Decreto -N%C2%B048.pdf  
https://members.wto.org/crnattachments/2023/TBT/CHL/final_measure/23_13338_0
0_s.pdf  
[ ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:  
 
1 This information can be provided by including a website address, a PDF attachment, or other 
information on where the text of the final measure/change to the measure/interpretative guidance can be 
obtained.  G/TBT/N/CHL/479/Add.1  
- 2 - 
  [ ] Content or scope of notified measure changed and text available from1: 
New deadline for comments (if applicable):  
[ ] Interpretive guidance issued and text available from1: 
[ ] Other:  
 
Description : The Republic of Chile hereby advises that the draft replacing the Technical Standard 
"Guide to conducting and submitting stability studies for pharmaceutical products" (Ministry of 
Health Exempt Supreme Decree No. 29/2012), notified by the World Trade Organ ization on 2 6 June 
2019 in document G/TBT/N/CHL/479, was published in the Official Journal on 3 November 2 023. 
The update of the technical standard approved by this Decree will come into force 24 months after 
its publication in the Official Journal.  
______ ____  