G/TBT/N/CHL/506  
30 October  2019 
(19-7248) 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 - Subsecretaría de Salud Pública 
(Ministry of Health - Undersecretariat for Public Health)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regardi ng the notification shall be indicated if different from above:  
Subsecretaría de Relaciones Económicas Internacionales, SUBREI - Ministerio de 
Relaciones Exteriores de Chile (Undersecretariat for International Economic Relations, 
Ministry of Foreign Affair s of Chile)  
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) : 
Radiopharmaceutical products  
5. Title, number of pages and language(s) of the notified document : Buenas Practicas 
de Manufacturas (BPM) de Productos Radiofarmacéuticos  (Good Manufacturing Practices 
(GMP) for Radiopharmaceutical Products) (20 pages, in Span ish) 
6. Description of content : The notified Technical Standard establishes guidelines, the main 
aim of which are to set out the basic specific requirements for the manufacturing of 
radiopharmaceutical products, and to supplement, in an Annex, the require ments 
established for sterile and non -sterile pharmaceutical products in Technical Standard No. 
127 of 2013 of the Ministry of Health (MINSAL) on Good Manufacturing Practices (GMP) for 
the pharmaceutical industry, published pursuant to MINSAL Exempt Decree  No. 159 of 1 1 
April 2 013, which updates Technical Standard No. 127 adopted in 2012.  
In view of the above, establishments manufacturing sterile radiopharmaceutical products 
must comply with the notified Standard, as well as with Annex No. 2 of Technical St andard 
No. 127, which updates and amends the Standard.  
This Technical Standard shall apply to the manufacturing procedures used by 
pharmaceutical laboratories producing radiopharmaceutical products and research 
institutions developing radiopharmaceuticals.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health or safety ; Quality requirements.  G/TBT/N/CHL/506  
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  8. Relevant documents:  
•  Norma Técnica Nº 127 de 2013 del Ministerio de Salud sobre Buenas Prácticas de 
Manufactura (BPM/GMP) para la Industria de Productos Farmacéuticos , published 
pursuant to Decreto Exento MINSAL Nº 159 of 11 April 2 013, which updates Norma 
Técnica Nº 127  adopted in 2012;  
•  Anexo Nº 2 de la Norma Técnica Nº 127 , which updates and amends the Standard;  
•  Reglamento del Sistema Nacional de Control de los Productos Farmacéuticos de 
Uso Humano (D.S Nº 3/2010) en el Código Sanitario.  
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  - Ministerio de Relaciones 
Exteriores  de Chile  (Undersecretariat for International Economic Relation s, Ministry of 
Foreign Affairs of Chile)  
Teatinos 180, piso 11  
Tel.: (+56)-2- 2827 5250  
Fax: (+56)-2- 2380 9494  
Email: Tbt_Chile@direcon.gob.cl  
https://www.minsal.cl/consultas -publicas -vigentes/  
https://members.wto.org/crnattachments/2019/TBT/CHL/19_6066_00_s.pdf