G/SPS/N/COL/285  
29 May 2018 
(18-3200) 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) : Homeopathic medicines 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 estab lecen los requisitos y el procedimiento 
para el registro ante el ICA de los medicamentos homeopáticos de uso veterinario y se 
dictan otras disposiciones"  (Draft Colombian Agricultural Institute (ICA) Resolution 
establishing the requirements and procedure f or the registration with the ICA of 
homeopathic medicines for veterinary use and adopting other provisions) Language(s) : 
Spanish Number of pages : 30 
https://members.wto.org/crnattachments/2018/SPS/COL/18_2729_00_s.pdf  
6. Description of content : The notified draft Resolution establishes the requirements and 
procedure for the registration with the ICA of homeopathic medicines for veterinary use.  
The dra ft text covers the following : Purpose ; Scope; Definitions ; Registration of 
homeopathic medicines for veterinary use ; Labelling ; Review of registration request ; 
Procedures for issuing registration certificates ; Issuance of registration certificates ; 
Amendme nts to registration ; Obligations ; Prohibitions ; Cancellation of registration ; 
Authorization to import raw materials for the manufacturing of homeopathic medicines for 
veterinary use exclusively for export ; Other provisions ; Official control ; Penalties ; 
Transitional provision ; 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 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/285  
- 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:  
Decreto 1071 de 2015 (Decree No. 1071 of 2015)  
Buenas Prácticas Clínicas establecidas por VICH  (Good clinical practices established 
by the International Cooperation on Harmonisation of Technical Requirements for 
Registration of Veterinary Medicinal Products - VICH)  
(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 ): 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 ): 28 July 2 018 
Agency or authority designated to handle comments : [X] National Notification 
Authority, [X]  National E nquiry Point . Address, fax number and email address (if 
available) of other body:  
Ministerio de Comercio, Industria y Turismo  
Dirección de Regulación  (Regulation Department)  
Calle 28, N° 13A - 15, tercer piso  
Bogotá, D.C . Colombia  
Tel.: (+57) 1 606 7676, E xt. 1566/1340  
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 Division for International Affairs)  
Carrera 41 # 17 - 81, Piso 2 (Zona Industrial - Puente Aranda)  
Bogotá, D.C., Colombia  
Tel.: (+57) 1 332 3700 Ext. 1510  
Fax: (+57) 1 288 4800  
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  (Regulation Department)  
Calle 28, N° 13A - 15, tercer piso  
Bogotá, D.C., Colombia  
Enquiry point:  
Tel.: (+57) 1 606 7676, Ext. 1690  
Email:  mortizb@mincit.gov.co  
Website : http://www.mincit.gov.co/