G/TBT/N/CHL/246  
8 October 2013  
(13-5452)  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 , MINSAL (Ministry of Health) 
Name and address (including teleph one and fax numbers and e-mail 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 Arti cle 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 provid ed in addition, where applicable):  
Biotechnology products obtained using recombinant DNA techniques 
5. Title, number of pages and lang uage(s) of the notified document:  Norma Técnica 
de Registro Sanitario de Productos Biotecnológicos Derivados de Técnicas de ADN 
Recombinante (Technical Standard on the sanitary registration of biotechnology products 
obtained using recombinant DNA techniques) (27 pages, in Spanish). 
6. Description of content:  The notified draft Technical Standard establishes sanitary 
registration requirements and defines the active ingredients and pharmaceutical forms for 
which a shortened application may be submitted in respect of the scientific evidence 
provided in support of the sanitary registra tion process and the reference products used 
in comparability studies. 
This Technical Standard will apply in the context of the sanitary registration 
of biotechnology medicines to clarify the provisions of Ministry of Health Supreme Decree No. 3/10 and establish the rules on sanitary registration referred to in Article 42(i) 
thereof. An application for the registration of a bio-comparable product based on 
a reference biotechnology product may only be submitted for biotechnology products containing a clearly identified active substa nce and obtained using modern biotechnology 
methods, such as recombinant DNA techniques. 
This Standard does not apply to vaccines or plasma derivatives. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  - 
8. Relevant documents:  Norma Técnica de Registro Sanitario de Productos Biotecnológicos 
Derivados de Técnicas de ADN Recombinante  (Technical Standard on the sanitary 
registration of biotechnology products obtained using recombinant DNA techniques). 
9. Proposed date of adoption: 
Proposed date of entry into force:   - -  G/TBT/N/CHL/246 
- 2 - 
  10. Final date for comments:  1 December 2013 
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and e-mail 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 E-mail: tbt_chile@direcon.gob.cl  
Text available online at: 
http://www.minsal.cl/portal/url /page/minsalcl/g_varios/cons ultas_publicas/cp_home.html  
http://members.wto.org/crnattachments/2013/tbt/CHL/13_3966_00_s.pdf