G/TBT/N/CHL/286  
1 September 2014  
(14-4974)  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 governme nt involved (Articles 3.2 and 7.2):   
2. Agency responsible: Ministerio de Salud  (Ministry of Health) 
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: Ministerio de 
Relaciones Exteriores  (Ministry of Foreign Affairs) 
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): 
Pharmaceutical products 
5. Title, number of pages and lang uage(s) of the notified document: Modificación del 
Decreto Supremo N° 3 del Ministerio de Salud, que regula el Sistema Nacional de Control 
de los Productos Farmacéuticos de Uso Humano (Amendment to Ministry of Health 
Supreme Decree No. 3 regulating the National Sy stem for the Monitoring of Pharmaceutical 
Products for Human Use) 
6. Description of content: It has been decided that the following amendments are to be 
made to Supreme Decree No. 3 regulating the National System for the Monitoring of 
Pharmaceutical Products for Human Use: 
"Article 3 - Ministry of Health Supreme De cree No. 3 of 2010 approving the regulations of 
the National System for the Monitoring of Pharmaceutical Products for Human Use, 
published in the Official Journal of 25 June 2011, is hereby amended as follows: 
Replace Article 75 with the following text: 
Article 75 - Primary packaging must be printed with, at the very least, the information 
referred to in points 1, 2, 7, 9, 10 and 11 of Article 74. For medicines in packages that may be divided up under the respective regulati ons, this information, with the exception of 
points 7 and 11, must be displayed on the back  of each of the dosage units contained in 
the primary package; systems to assist in di viding up the package, such as perforation 
lines, must be used. 
Article 4 - Producers and importers of pharmaceutical products may distribute their 
products to pharmacies in carton-type packages to be divided up in accordance with 
existing regulations. 
Transitional Article - The provisions correspondi ng to the obligations under Article 3 of this 
decree, relating to the amendment of Supreme Decree No. 3 of 2010 and referring to the 
changes that medicine producers are to make to primary packages of pharmaceutical products that are required to be divided up, must be complied with within 60 months of the date of publication of the present amendment in the Official Journal". G/TBT/N/CHL/286 
- 2 - 
  7. Objective and rationale, including the nature of urgent problems where 
applicable: Human safety 
8. Relevant documents: Supreme Decree No. 3 of the Ministry of Health: 
http://www.ispch.cl/sites/default/fil es/u7/Decreto Supremo 3 Productos 
Farmac%C3%A9uticos de Uso Humano.pdf   
9. Proposed date of adoption: - 
Proposed date of entry into force: - 
10. Final date for comments: 60 days from the date of notification 
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:  
Departamento Regulatorio 
Dirección General de Relaciones Económicas Internacionales 
Ministerio de Relaciones Exteriores 
Teatinos 180, piso 11, Santiago Tel.: (+56) 2 827-5491 Fax: (+56) 2 380-9494 
Email: tbt_chile@direcon.gob.cl