G/TBT/N/COL/197  
2 August 2013  
(13-4164)  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: COLOMBIA 
If applicable, name of local governme nt involved (Articles 3.2 and 7.2):   
2. Agency responsible: Ministerio de Salud y Protección Social (Ministry of Health 
and Social Welfare) 
Name and address (including telephon e and fax numbers, 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 
Comercio, Industria y Turismo (Ministry of Commerce, Industry and Tourism) 
3. Notified under Article 2.9.2 [ ], 2. 10.1 [ ], 5.6.2 [X], 5.7.1 [ ], other:   
4. Products covered (HS or CCCN wher e applicable, otherwise national tariff 
heading. ICS numbers may be provided  in addition, where applicable): Vaccines 
5. Title, number of pages and language(s) of the notified document: Proyecto de 
Resolución del Ministerio de Salud y Protección Social "Por la cual se establecen unas 
disposiciones relacionadas con las vacunas que se comercialicen en el país"  
(Draft Ministry of Health and Social Welfare Resolution "Establishing provisions governing 
vaccines marketed in Colombia") (14 pages, in Spanish) 
6. Description of content: Technical information required for the control of vaccines; 
General information; Submission of summaries; Technical information (production 
and quality); Information on pre-clinical studies; Information on clinical studies on vaccines; Information to be included on labels and in notices; Information on vaccine 
batch release; Environmental aspects; and Inspection, monitoring and control. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human life and health. 
8. Relevant documents: Law ( Ley) No. 09 of 24 January 1979, Decree-Law ( Decreto ley ) 
No. 019 of 10 January 2012, Decree ( Decreto ) No. 677 of 26 April 1995 and Resolution 
(Resolución ) No. 1229 of 2013 of the Ministry of Health and Social Welfare. 
9. Proposed date of adoption: 
Proposed date of entry into force:   Date on which the Resolution is signed. 
Six (6) months as from the date 
of publication in the Official Journal. 
10. Final date for comments: 1 November 2013 G/TBT/N/COL/197 
- 2 - 
  11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers, e-mail and website addresses,  if available of the other body: 
 
Enquiry Point: 
 Contact person: Daniel Héctor Rico R. 
E-mail: drico@mincit.gov.co  
 puntocontacto@mincit.gov.co  
Tel.: (+57) 1 606-7676, Ext. 1690 
Fax: (+57) 1 606-4777 
 Ministerio de Comercio, Industria y Turismo 
Dirección de Regulación 
Calle 28 Nº 13A - 15, tercer piso Bogotá, D.C., Colombia Tel.:  (+57) 1 606-4775 
 
Ministerio de Salud y Protección Social Dirección de Medicamentos y Tecnología en Salud 
Carrera 13 N° 32 - 76 
Bogotá, D.C., Colombia Tel.: (+57) 1 330-5000, Ext. 1251 
Fax: (+57) 1 330-5050, Ext. 1250 
E-mail: bolarte@minsalud.gov.co  
 nhuertas@minsalud.gov.co 
Website: http://www.minproteccionsocial.gov.co  
 
Text also available at: http://members.wto.org/crnattachments/2013/tbt/COL/13_3064_00_s.pdf