G/SPS/N/COL/313  
9 September  2019 
(19-5756) 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) : 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 "Por medio de la cual se 
establecen las Buenas Prácticas de Manufactura en las Empresas productoras, 
productoras por contrato y/o semielaboradoras de productos farmacéuticos, 
ectoparasiticidas y desinfectantes de uso veterinario" (Draft Resolution establishing good 
manufacturing practices for producers, contracted producers and/or semi -proces sors of 
pharmaceutical products, ectoparasiticides and disinfectants for veterinary use) 
Language(s) : Spanish Number of pages : 13 
Text available at:  
https://members.wto.org/crnattachments/2019/SPS/COL/19_4836_00_s.pdf  
6. Description of content : The notified draft Resolution establishes good manufacturing 
practices for p roducers, contracted producers and/or semi -processors of pharmaceutical 
products, ectoparasiticides and disinfectants for veterinary use.  
It is necessary to establish certification conditions regarding good manufacturing practices 
for natural or legal pers ons 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 phytosanitary status.  
7. Objective a nd rationale : [X] 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/313  
- 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 : 
Resoluciones ICA -1056 de 1996 y 3826 de 2003  (available in Spanish)  
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 circula tion of the 
notification and/or ( dd/mm/yy ): 8 November 2 019 
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 Trade, 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:  ngarcia@mincit.gov. co 
 mgonzalezs@mincit.gov.co  
Website: http://www.mincit.gov.co  
13. Text(s) available from : [X] National Notification Authority, [ ] National Enquiry 
Point . Address, fax number and email address (if available) of other body:  
Ministerio de Comercio, Industria y Turismo  (Ministry of Trade, 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:  ngarcia@mincit.gov.co  
 mgonzalezs@mincit.gov.co  
Website: http://www.mincit.gov.co  
Instituto Colombiano Agropecuario , ICA (Colombian Agricultural Institute)  
Subger encia de Regulación Sanitaria y Fitosanitaria (Sanitary and Phytosanitary 
Regulation Division)  
Dirección Técnica de Asuntos Internacionales  (Technical Division for International Affairs)  
Avenida Calle 26 N° 85B -09 
Bogotá - Colombia  
Tel.: (+57 1) 332 3700 - 288 48 00, Ext. 1510 - 1515 
Email:  asuntos.internacionales@ica.gov.co  
 margarita.lubo@ica.gov.co  
Website: http://www.ica.gov.co  
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