. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/COL/125 
27 February 2009 
 (09-1021) 
Committee on Technical Barriers to Trade Original:   Spanish 
 
 
 
NOTIFICATION 
 
The following notification is being circulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:  COLOMBIA  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:   Ministerio de la Protección Social  (Ministry of Social Welfare)  
Name and address (including telephone 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 
Comercio, Industria y Turismo  (Ministry of Commerce, Industry and Tourism) 
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):  Medical gases 
5. Title, number of pages and lang uage(s) of the notified document:  Proyecto de "Manual 
de Buenas Prácticas de Manufac tura de los Gases Medicinales" (Draft Handbook of good 
manufacturing practices for medical gases) (51 pages, in Spanish). 
6. Description of content:   Glossary;  General considerations;  Quality assurance;  Good 
manufacturing practices f or medical gases;  Qua lity control;  Sanitation and hygiene;  
Validation;  Complaints;  Product withdrawal;  Production and analysis on a contract basis;  
Self-inspection and quali ty audits;  Staff;   F acilities;  Equipment;  Materials;  
Documentation;  Good production practices;  Good quality control practices;  Distribution;  
Production of medical oxygen in situ by the molecular sieve process;  Production of 
medical air in situ using a compressor;  Other provisions. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human life and health. 
8. Relevant documents:   National Fire Production A ssoci ation (NFPA) Standard No. 99;  
International Organization for Standard ization (ISO) Standard 1008 3:1992:  Oxygen 
concentrators for use with medical gas pipeline systems ;  Report No. 32 of the 
World Health Organization;  Resoluti on No. 1672 of 28  May 2004 and Resolution 
No. 3862 of 2005 of the Colombian Ministry of Social Welfare. 
9. Proposed date of adoption: 
Proposed date of entry into force:  Date on which the Resolution is signed. 
Twelve (12) months after the date of publication in the Official Journal. G/TBT/N/COL/125 
Page 2  
 
  10. Final date for comments:   20 May 2009 
11. Texts available from:  National enquiry point [ X] or address, telephone and fax 
numbers, E-mail and website addresses,  if available, of other body:  
Enquiry Point : 
Contact person:  Daniel Héctor Rico R. 
Tel.: (+571) 606-7676, ext. 1690 Fax: (+571) 241-0480 E-mail: drico@mincomercio.gov.co
 
 
Ministerio de Comercio, Industria y Turismo 
Dirección de Regulación Calle 28 No. 13A-15, tercer piso Bogotá, D.C., Colombia Tel.: (+571) 241-0478 
Website: http://secgen.comunidadandina.org/sirt
 
 
Ministerio de la Protección Social Dirección General de Calidad de Servicios Grupo de Medicamentos e Insumos Carrera 13 No. 32-76 
Bogotá, D.C., Colombia 
Tel.: +(571) 330-5000, exts. 1860 to 1865 Fax: +(571) 336-0182 E-mail: lpino@minproteccionsocial.gov.co
 
Website: http://www.minproteccionsocial.gov.co