G/SPS/N/COL/316  
3 June 2020 
(20-3916) Page: 1/3 
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) : Pharmaceutical products, ectoparasiticides and disinfectants 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 del Instituto Colombiano 
Agropecuario - ICA "Por medio de la cual se establecen la Buena s Prácticas de 
Manufactura en las Empresas productoras, productoras por contrato y/o 
semielaboradoras de productos farmacéuticos, ectoparasiticidas y desinfectantes de uso 
veterinario" (Draft Resolution of the Colombian Agricultural Institute establishing good 
manufacturing practices for producers, contracted producers and/or semi -processors of 
pharmaceutical products, ectoparasiticides and disinfectants for veterinary use) 
Language(s) : Spanish Number of pages : 13 
https://members.wto.org/crnattachments/2020/SPS/COL/20_3479_00_s.pdf  
6. Description of content : The notified draft Resolution of the Colombian Agricultural 
Institute establishes good manufacturing practices for producers, contracted producers 
and/or semi -processors of pharmaceutical products, ectoparasiticides and disinfectants 
for veterinary use.  
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 . The Colombian Agricultural Institute is responsible for 
regulating the production, quality control, marketing and import of vet erinary biologics 
and medicinal products . It determined the need to establish certification conditions 
regarding good manufacturing practices for natural or legal persons engaged in the 
production, contracted production or semi -processing of pharmaceutical  products, 
ectoparasiticides and disinfectants for veterinary use, with the aim of ensuring safety and 
safeguarding the country's sanitary status.  G/SPS/N/COL/316  
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  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. ISPM 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 the 
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 Official Journal  
11. Proposed date of entry into force : [ ] Six months from date of publication, and/or 
(dd/mm/yy ): Date of publication  
[ ] Trade facilitating measure  
12. Final date for comments : [X] Sixty days from the date of circulation of the 
notification and/or ( dd/mm/yy ): 2 August 2 020 
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 No. 13A - 15, tercer piso  
Bogotá, D.C., Colombia  
Tel.: (+571) 606 7676, Ext. 1690/1340  
Email: puntocontac to@mincit.gov.co  
mgonzalezs@mincit.gov.co  
amejiam@mincit.gov.co  
Website: http://www.mincit.gov.co  
 
Institu to Colombiano Agropecuario , ICA (Colombian Agricultural Institute)  
Subgerencia de Regulación Sanitaria y Fitosanitaria (Sanitary and Phytosanitary 
Regulation Division)  
Dirección Técnica de Asuntos Internacionales  (Technical Division for International Affai rs) 
Avenida Calle 26 No. 85B-09 
Bogotá, D.C., Colombia  
Tel.: (+571) 332 3700  
(+571) 288 4800, Ext. 1510/1515  
Email: asuntos.internacionales@ica.gov.co  
margarita.lubo@ica.gov.co  
Website: http://www.ica.gov.co  G/SPS/N/COL/316  
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  13. Text(s) available from : [ ] 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 No. 13A - 15, tercer piso  
Bogotá, D.C., Colombia  
Tel.: (+571) 606 7676, Ext. 1690/1340  
Email: puntocontacto@mincit.gov.co  
mgonzalezs@mincit.gov.co  
amejiam@mincit.gov.co  
Website: http://www.mincit.gov.co