G/TBT/N/COL/202  
8 May 2014  
(14-2839)  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 governme nt involved (Articles 3.2 and 7.2):   
2. Agency responsible: Ministerio de Salud y Protección Social  (Ministry of Health and 
Social Welfare) 
Name and address (including telephone and fax numbers and 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 [X], 2. 10.1 [ ], 5.6.2 [X], 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): Biological 
medicines 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
Resolución del Ministerio de Salud y Protección Social "Por el cual se expide el Manual de Buenas Prácticas de Manufactura para la fabricación de medicamentos biológicos y se 
establece el instrumento para su verificación y se dictan otras disposiciones" (Draft 
Ministry of Health and Social Welfare Resolution "issuing the Handbook of Good Manufacturing Practices for biological medicines, establishing the instrument for verifying 
such practices, and adopting other provisions") (51 pages, in Spanish)  
6. Description of content: The notified draft Resolution covers the following: Purpose; 
Scope; Requirements for obtaining a certificate of compliance with good manufacturing 
practices for biological medicines; Acceptance of foreign certification; Transitional provision; Certification of good manufacturing practices for laboratories with facilities 
producing chemically synthesized and biological medicines; Notification; Period of validity 
and derogations; Annex 1, Handbook of Good Manufacturing Practices for biological medicines: 1. Scope, 2. Principles, 3. Organization and personnel, 4. Sanitation and hygiene, 5. Installations and critical support systems, 6. Equipment, 7. Animal facilities 
and animal care, 8. Inputs and starting materials, 9. Production, 10. Aseptic preparations, 
11. Sterilization, 12. Terminal sterilization, 13. Aseptic processing and sterilization by 
filtration, 14. Isolation technology, 15. Blow-f ill-seal technology, 16. Finishing of sterile 
products, 17. Labelling, 18. Batch production records and distribution records, 19. Quality 
assurance and control, and Annex 2, Instrument for verifying good manufacturing practices for biological medicines. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: To protect the health of users of biological medicines. 
8. Relevant documents: Ministry of Health Decree No. 549 of 29 March 2001 (notified in 
document G/TBT/N/COL/4) and Decree No. 162 of 22 January 2004; Resolution No. 3183 
of 23 August 1995 and Resolution No. 1087 of 5 July 2001 (notified in document 
G/TBT/N/COL/4/Add.1).  G/TBT/N/COL/202 
- 2 - 
  9. Proposed date of adoption: 
 
Proposed date of entry into force:   Date on which the Resolution is signed. 
One year after the date of publication in 
the Official Journal. 
10. Final date for comments: 6 August 2014 
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresse s, if available, of other body:  
Contact person: Daniel Héctor Rico R. 
Email: drico@mincit.gov.co ; puntocontacto@mincit.gov.co  
Tel.: (+57-1) 606-7676, Ext. 1690 
Fax: (+57-1) 606 4777 
Ministerio de Comercio, Industria y Turismo Dirección de Regulación 
Tel.: (+57-1) 606-4775 
Calle 28 No. 13A - 15, tercer piso Bogotá, D.C., Colombia 
Ministerio de Salud y Protección Social 
Dirección de Medicamentos y Tecnologías en Salud 
Carrera 13 N° 32 - 76 Bogotá, D.C., Colombia 
Tel.: (+57-1) 330-5000, Ext. 1251 
Fax: (+57-1) 330-5050, Ext. 1250 Email: bolarte@minsalud.gov.co ;nhuertas@minsalud.gov.co  
Website: http:/www.minpro teccionsocial.gov.co/ 
Also available at: http://members.wto.org/crnattachments/2014/tbt/COL/14_2273_00_s.pdf