G/SPS/N/COL/299  
23 October  2018 
(18-6635) Page: 1/2 
Committee on Sanitary and Phytosanitary 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) : Foot-and-mouth disease vaccines  
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 del Instituto Colombiano 
Agropecuario - ICA "Por medio de la cual se establecen los req uisitos y el procedimiento 
para el registro y la verificación de calidad de la vacuna contra la fiebre aftosa " (Draft 
Resolution of the Colombian Agricultural Institute (ICA) establishing registration and 
quality control requirements and procedures for foo t-and-mouth disease vaccines) . 
Language(s) : Spanish Number of pages : 24 
https://members.wto.org/crnattachments/2018/SPS/COL/18_5563_00_s.pdf  
6. Description of  content : Registration and quality control requirements and procedures 
are established for foot -and-mouth disease (FMD) vaccines.  
The draft resolution covers the following : purpose, scope, definitions, FMD vaccines, 
registration of FMD vaccines, requiremen ts for registration of FMD vaccines, labelling and 
inserts, review of registration requests, procedure for issuing registration certificates, 
assessment of registration request documents, vaccine quality control, quality control 
testing, bovine animals use d for vaccine check tests, potency, purity, issuance of 
registration certificates, changes to registration, obligations, prohibitions, cancellation of 
registration, other provisions, official control, penalties, transitional provision.  
7. Objective and ra tionale : [ ] food safety , [X] animal health , [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from 
other damage from pests.  
8. Is there 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) : 
[ ] International Plant Protection Convention ( e.g. I SPM No. ): G/SPS/N/COL/299  
- 2 - 
  [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 the 
international standard:   
9. Other relevant documents and language(s)  in which these are available : Decree 
No. 1071 of 2015 - Current good clinical practices established by VICH, the International 
Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products, in its guide "Good Cli nical Practice " 
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 Official Journal.  
11. Proposed date of entry into force : [ ] Six months from date of publication, and/or 
(dd/mm/yy ): Upon publication in the Official Journal.  
[ ] Trade facilitating measure  
12. Final date for comments : [X] Sixty days from the date of circulation of the 
notification and/o r (dd/mm/yy ): 22 December 2018 
Agency or authority designated to handle comments : [X] National Notification 
Authority, [X]  National Enquiry Point . Address, fax number and email address 
(if available) of other body:  
Ministerio de Comercio, Industria y Turismo  (Ministry of Commerce, Industry and 
Tourism)  
Dirección de Regulación  (Regulation Department)  
Calle 28 N° 13A - 15, tercer piso  
Bogotá, D.C., Colombia  
Tel.: (+571) 606 7676, Ext. 1690 - 1340 
Email : mortizb@mincit.gov.co  
mgonzalezs@mincit.gov.co  
Website: http://www.mincit.gov.co  
Instituto Colombiano Agropecuario , ICA (Colombian Agricultural Institute)  
Subgerencia de Regulación Sanitaria y Fitosanitaria (Sanitary and Phytosanitary 
Regulation Division)  
Dirección Técnica de Asuntos Internacionales  (Technical Di vision for International Affairs)  
Avenida Calle 26 N° 85B -09 
Bogotá - Colombia  
Tel.: (+571) 332 3700 - 288 4800, Ext. 1510 - 1515 
Email : asuntos.internacionales@ica.gov.co  
Website: http://www.ica.gov.co  
13. Text(s) available from : [X] National Notification Authority, [X]  National 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 poi nt: 
Email : mortizb@mincit.gov.co  
Tel.: (+571) 606 7676, Ext. 1690  
Website: http://www.mincit.gov.co