G/TBT/N/COL/224  
1 June 2017  
(17-2935) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : COLOMBIA  
If applicable, name of local government involved (Articles 3.2 and 7.2):   
2. Agency responsible : Ministerio de Salud y Protección S ocial (Ministry of Health and 
Social Welfare)  
Name and address (including telephone and fax numbers, email 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 [ ], 2.10.1 [X], 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) : Antivenins  
5. Title, number of pages and language(s) of the notified document : Decreto 821 de 
2017 "Por el cual se establece el reglamento técnico de emergencia para la obtención del 
registro sanitario de antivenenos y se adopta la Guía de Buenas Prácticas de Manufactura 
para su fabricación" (Decree No. 821 of 2017 establishing the emergency technical 
regulation on the sanitary registration of antivenins and adopting the guide to good 
manufacturing practices for antivenins) (25 pages, in Spanish)  
6. Description of content : The notified decree establishes the sanitary requirements to be 
met by any person in Colombia wishing to import or manufacture antivenins for treating 
injuries caused  by venomous animals . It also adopts a guide to good manufacturing 
practices for antivenins.  The text covers the following : Purpose ; Scope; Definitions ; 
Antivenin sanitary registration procedures ; Pharmacological evaluation for antivenin 
sanitary registrat ion purposes ; Pharmaceutical evaluation of antivenins for sanitary 
registration purposes ; Legal evaluation for antivenin sanitary registration purposes ; 
Renewal of sanitary registration ; Changes to sanitary registration ; Depletion of stocks of 
products and  packaging on the market ; Certificate of good manufacturing practices and 
release of batches of antivenin ; Pharmacovigilance , inspection, surveillance and control, 
and supply of antivenins ; and Final provisions.  
7. Objective and rationale, including the n ature of urgent problems where 
applicable : The notified text seeks to protect human life and health . For public health 
reasons and given the threat to health posed by the continuing increase in injuries caused 
by venomous animals, it is necessary to urgent ly establish specific sanitary regulations 
governing the domestic manufacture and importation of antivenins used in the country . 
Colombia has therefore introduced the notified emergency technical regulation, which sets 
forth sanitary requirements without p rejudice to the quality, safety and effectiveness of the 
product.  
8. Relevant documents : Decree No. 677 of 1995  G/TBT/N/COL/224  
- 2 - 
  9. Proposed date of adoption : Date of signature  
Proposed date of entry into force : 16 May 2 017 
10. Final date for comments : Not applicable  
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Enquiry point : 
Contact person : Daniel Héctor Rico R.  
Email:  drico@mincit.gov.co ; 
 mgonzalezs@mincit.gov.co  
Tel.: (+57-1) 6067676, Ext. 1690  
Website: http://www.mincit.gov.co/publicaciones.php? id=33051  
Ministerio de Comercio, Industria y Turismo  
Dirección de Regulación  
Tel.: (+57-1) 6064775  
Calle 28, N° 13A - 15, tercer piso  
Bogotá, D.C . Colombia  
Ministerio de Salud y Protección Social  
Sudirección de Salud Nutricional Alimentos y Bebidas  
Direcc ión de Promoción y Prevención  
Carrera 13 N° 32 - 76 
Bogotá, D.C., Colombia  
Tel.: (+57-1) 3305000, Ext. 1251  
Email: bolarte@minsalud.gov.co  
Website : http://www.minproteccionsocial.gov.co  
Also available at:  
https://members.wto.org/crnattachments/2017/TBT/COL/17_2517_00_s.pdf