WORLD TRADE  
ORGANIZATION  G/SPS/N/COL/200 
10 August 2010 
 (10-4260) 
Committee on Sanitary a nd 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 numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Medicines, biologics, bases for magistral preparations, cosmetics, pesticides, 
miscellaneous veterinary products and diagnostic kits and reagents 
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 requisitos para el registro de 
productor, semielaborador, almacenador e im portador de medicamentos, biológicos, 
drogas blancas, cosméticos, plagui cidas, productos varios veteri narios, kit y reactivos de 
diagnóstico, y se establecen otras disposiciones" (Draft Resolution of the Colombian 
Agricultural Institute "Laying down the re quirements governing the registration of 
producers, semi-manufacturers, storage provide rs and importers of medicines, biologics, 
bases for magistral preparations, cosmetics, p esticides, miscellaneous veterinary products 
and diagnostic kits and reagents, and establishing other provisions") Language:  Spanish 
Number of pages:  42 
Text available online at: 
http://members.wto.org/crnattach ments/2010/sps/COL/10_3101_00_s.pdf  
6. Description of content:  The notified draft Resolution estab lishes the requirements for the 
registration and control of natu ral and legal persons  engaged in the production, contract 
production, semi-manufacturing, importation and storage of medicines, biologics, bases for magistral preparations, cosmetics, pesticid es, miscellaneous veterinary products and 
diagnostic kits and reagents.  The Resolution covers the following:  Purpose;  Scope;  
Definitions;  Registration;  Registration procedur es;  Technical visit;  Issue of registration;  
Technical tests;  Product registration;  Pro cedures for and issue of product registration;  
Labelling;  Amendment or cancellation of regi stration;  Research and experimentation;  
Obligations;  Prohibitions;  Certification of good practices;  Official control;  Documentation;  Penalties;  and Period of validity. G/SPS/N/COL/200 
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  7. Objective and rationale:  [ ] food safety, [X] animal health, [ ] plant protection, 
[X] protect humans from animal/plant pest or disease, [X] protect territory from other damage from pests.  
8. Is there a relevant international stan dard?  If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial number of Codex standard 
or related text)  
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)  
[ ] International Plant Protection Convention (e.g. ISPM number)  
[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:  Andean 
Community Decision No. 483 of 8 June 2000;  Decree No. 1840 of 3 August 1994;  
Colombian Agricultural Institute (ICA) Resolu tion No. 1056 of 17 April 1996, except for 
Articles 26 to 29;  ICA Resolution No. 2377 of 1996;  ICA Resolution No. 353 of 1998;  ICA Resolution No. 2045 of 1999;  ICA Resolu tion No. 588 of 2000;  and ICA Resolution 
No. 1704 of 2002 (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) :  As from the date of publication in the Official Journal 
[ ] Trade facilitating measure 
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  9 November 2010 
Agency or authority designated to handle comments:  [X] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:  
Servicio Nacional de Información 
Ministerio de Comercio, Industria y Turismo Dirección de Regulación Calle 28 N° 13A - 15, tercer piso 
Tel.: +(57 1) 606-4775 
Fax: +(57 1) 606-4777   G/SPS/N/COL/200 
 Page 3 
 
 
   or 
Instituto Colombiano Agropecuario - ICA 
Subgerencia de Regulación Sanitaria y Fitosanitaria Dirección Técnica de Asuntos Internacionales Calle 37 # 8-43, Piso 4, Oficina 411 
Bogotá, D.C., Colombia 
Tel.: +(571) 287-2728 Fax: +(571) 285-3485 
Website: http://www.ica.gov.co/
 
13. Texts available from:  [X] National Notification Authority, [X] National Enquiry 
Point.  Address, fax number and e-mail 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. 
E-mail: drico@mincomercio.gov.co 
 Puntocontactotc-msf@mincomercio.gov.co Tel.: +(57 1) 606-7676, Ext. 1690 Fax: +(57 1) 606-4777