. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/COL/153 
11 August 2010 
 
 (10-4278) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:  COLOMBIA
 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:   Instituto Colombiano Agropecuario , ICA  (Colombian Agricultural 
Institute) Name and address (including telephone and fax numbers and E-mail and website addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   Ministerio de 
Comercio, Industria y Turismo (Ministry of Commerce, Industry and Tourism) 
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):   Medicines, biologics, 
bases for magistral preparations, cosmetics, p esticides, miscellaneous veterinary products 
and diagnostic kits and reagents 
5. Title, number of pages and lang uage(s) of the notified document:   Proyecto de 
Resolución del Instituto Colombiano Agrop ecuario – ICA "Por medio de la cual se 
establecen los requisitos para el registro de  productor, semielaborador, almacenador e 
importador de medicamentos, biológicos, drogas blancas, cosméticos, plaguicidas, 
productos varios veterinarios, kit y reactiv os de diagnóstico, y se establecen otras 
disposiciones" (Draft Resolution of the Colombian Ag ricultural Institute "Laying down the 
requirements governing the registration of  producers, semi-manufacturers, storage 
providers and importers of medicines, biologics, bases for magistral preparations, cosmetics, pesticides, miscellaneous veterinary  products and diagnostic kits and reagents, 
and establishing other provisions") (42 pages, in  Spanish). 
6. Description of content:   The notified draft Resolution est ablishes 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. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
To prevent risks to the environmen t and to human and animal health. G/TBT/N/COL/153 
Page 2  
 
  8. Relevant documents:   Andean Community Decision No. 483 of 8 June 2000;  Decree 
No. 1840 of 3 August 1994;  Colombian Agri cultural Institute (ICA)  Resolution 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 Resolution No. 588 of 2000;  and ICA Resolution No. 1704 of 2002. 
9. Proposed date of adoption: 
 
Proposed date of entry into force:  Date on which the Resolution is signed 
As from the date of publication in the 
Official Journal 
10. Final date for comments:   9 November 2010 
11. Texts available from:  National enquiry  point [X] or address, telephone and fax 
numbers, E-mail and website addresses,  if available, of other body:  
Enquiry Point : 
Contact person:  Daniel Héctor Rico R. 
E-mail:  drico@mincomercio.gov.co and Puntocontactotc-msf@mincomercio.gov.co 
Tel.: +(57-1) 606-7676, Ext. 1690 Telefax: +(57-1) 606-4777  Ministerio de Comercio, Industria y Turismo 
Dirección de Regulación 
Calle 28 Nº 13A - 15, tercer piso Bogotá, D.C., Colombia Tel.: +(57-1) 606-4775 Document available at:  https://servicios.vuce.gov.co/puntocon/ 
 
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.: +(57-1) 287-2728 Fax: +(57-1) 285-3485 Website: http://www.ica.gov.co/
 
Document available at: http://members.wto.org/crnattach ments/2010/tbt/col/10_3100_00_s.pdf