G/TBT/N/COL/196  
19 July 2013  
(13-3871)  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 telephone and fax numbers and e-mail and website addresses, if availa ble) of agency or author ity 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 where applicable, otherwise national tariff 
heading. ICS numbers may be provided  in addition, where applicable): Biological 
medicines 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
Decreto del Ministerio de Salud y Protección Social "Por el cual se reglamenta, para 
propósitos del registro sanitario, el procedimiento de evaluación de calidad, seguridad y 
eficacia de los medicamentos biológicos y se dictan otras disposiciones" (Draft Ministry of 
Health and Social Welfare Decree "Regulating the procedure to assess the quality, safety 
and efficacy of biological medicines for sanitary registration purposes , and adopting other 
provisions") (10 pages, in Spanish).  
6. Description of content: Purpose; Definitions; Pharmacological evaluation; Pathways for 
the submission of information for pharmacological evaluation; Full dossier pathway; Comparability pathway; Abbreviated pathway; Information common to all three 
pathways; Evaluation of information submitted; Evaluation criteria; Approval of 
indications; Information required for the pharmacological evaluation of biological 
medicines; Good manufacturing practices (GMPs) for biological medicines; Batch release; Pharmacological evaluation procedure; Sanitary registration; Prerequisite for sanitary 
registration; Sanitary registration procedure; Period of validity of sanitary registration; 
Renewal of sanitary registration for biological medicines; Changes to the sanitary registration of biological medicines; Nomenclature for sanitary registration; Unregulated 
aspects; Adoption of guidelines; Development of guidelines; General criteria for the 
adoption and development of guidelines; Institutional aspects; and Pharmacovigilance. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: To protect human life and health 
8. Relevant documents: Law ( Ley) No. 100 of 23 December 1993 and Law No. 1438 of 19 
January 2011; Decree ( Decreto ) No. 677 of 26 April 1995; Ministry of Health Decree No. 
549 of 29 March 2001  (notified in document G/TBT/N/COL/4); and Decree No. 162 of 22 
January 2004.  G/TBT/N/COL/196 
- 2 - 
  9. Proposed date of adoption: 
Proposed date of entry into force:   Date on which the Decree is signed 
Upon issuance of the guidelines on 
immunogenicity and stability 
10. Final date for comments: 9 October 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:  
Enquiry Point 
Contact person: Daniel Héctor Rico R. E-mail: drico@mincomercio.gov.co ; puntocontacto@mincomercio.gov.co  
Tel.: +(57-1) 606-7676, Ext. 1690 
Fax: +(57-1) 606-4777 Ministerio de Comercio, Industria y Turismo 
Dirección de Regulación 
Tel.: +(57-1) 606-4775 Calle 28 No. 13A - 15, tercer piso Bogotá, D.C., Colombia 
 
Ministerio de Salud y Protección Social  (Ministry of Health and Social Welfare) 
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.minpro teccionsocial.gov.co/ 
Also available at: 
http://members.wto.org/crnattachments/2013/tbt/COL/13_2718_00_s.pdf