G/SPS/N/COL/266  
14 March  2017 
(17-1463) Page: 1/2 
Committee on Sanitary and Phytos anitary Measures  Original:  Spanish  
 
  NOTIFICATION  
1. Notifying Member : COLOMBIA  
If applicable, name of local government involved:  
2. Agency responsible : Instituto Colombiano Agropecuario , ICA (Colombian Agricultural 
Institute)  
3. Products covered (provide tariff item number(s) as specified  in national 
schedules deposited with the WTO ; ICS numbers should be provided in addition, 
where applicable) : Medicines and biological products for veterinary use.  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document : Proyecto de resolución "Por medio de la cual se 
establece el Sistema Nacional de Farmacovigilancia para medicamentos y biológicos de uso 
veterinario"  (Draft Resolu tion establishing the national pharmacovigilance system for 
medicines and biological products for veterinary use) Language(s) : Spanish Number of 
pages : 24 
http://members.wto. org/crnattachments/2017/SPS/COL/17_1269_00_s.pdf  
6. Description of content : The notified draft Resolution establishes the national 
pharmacovigilance system for medicines and biological products for veterinary use.  
The text covers the following : Purpose ; Scope; Definitions ; General objective of the 
national pharmacovigilance system ; Specific objectives of the national pharmacovigilance 
system ; Components of the national pharmacovigilance system ; Entities participating in 
the national pharmacovigilance syst em; Obligations of the ICA as regulatory authority ; 
Obligations of veterinary medicine and biological product sales licence holders and 
importers ; O bligations of reporters ; Information sources for the national 
pharmacovigilance system ; Information flow ; Periodic safety report (IPS) ; Events to 
report ; Report criteria ; Causation analysis investigation ; Causation categories ; Criteria for 
inclusion in the various categories ; Corrective actions ; Post-registration studies ; 
Communication and dissemination ; Transit ional provision ; Penalties ; and Period of validity.  
7. Objective and rationale : [ ] food safety , [X] animal health , [ ] plant protection, [ ] 
protect humans from animal/plant pest or disease, [ ] protect territory from 
other damage from pests.  
8. Is the re a relevant international standard ? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial number of Codex 
standard or related text) : 
[ ] World Organisation for Animal Health (OIE) (e.g. T errestrial or Aquatic 
Animal Health  Code, chapter number) : G/SPS/N/COL/266  
- 2 - 
  [ ] International Plant Protection Convention ( e.g. I SPM No. ): 
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes [ ] No 
If no, describe, whenever possible, how and why it deviates from th e 
international standard:   
9. Other relevant documents and language(s) in which these are available:  
10. Proposed date of adoption (dd/mm/yy) : Date on which the Resolution is signed.  
Proposed date of publication (dd/mm/yy) : Date of publication in the Of ficial Journal.  
11. Proposed date of entry into force : [ ] Six months from date of publication, and/or 
(dd/mm/yy) : Six months from the date of publication in the Official Journal.  
[ ] Trade facilitating measure  
12. Final date for comments : [X] Sixty day s from the date of circulation of the 
notification and/or (dd/mm/yy) : 13 May 2 017 
Agency or authority designated to handle comments : [X] National Notification 
Authority, [X]  National Enquiry Point . Address, fax number and email address (if 
available) of ot her body:  
Ministerio de Comercio, Industria y Turismo  
Dirección de Regulación  
Calle 28, N° 13A - 15, tercer piso  
Bogotá, D.C . Colombia  
Tel.: (+57) 1 6067676, Ext. 1690 - 1340 
Email:  drico@mincit.gov.co  
mgonzalezs@mincit.gov.co  
 
Ministerio de Salud y Protec ción Social  
Carrera 13 N° 32 -76 Código Postal 1120311  
Bogotá, D.C., Colombia  
Tel.: (+57) 1 3305000  
Website: http://www.minsalud.gov.co/  
13. Text(s) available from : [X] National Notification Authority, [X]  Nationa l Enquiry 
Point . Address, fax number and email address (if available) of other body:  
Ministerio de Comercio, Industria y Turismo  
Dirección de Regulación  
Calle 28, N° 13A - 15, tercer piso  
Bogotá, D.C., Colombia  
 
Enquiry point:  
Contact person : Daniel Héctor  Rico R.  
Email:  drico@mincit.gov.co  
Tel.: (+57) 1 6067676, Ext. 1690  
Website: http://www.mincit.gov.co/publicaciones.php?id=33051