G/TBT/N/COL/189  
31 January 2013  
(13-0547)  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 teleph one 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 provid ed in addition, where applicable):  
Pharmaceutical products 
5. Title, number of pages and lang uage(s) of the notified document:  Proyecto de 
Resolución del Ministerio de Salud y Protección Social "Por la cual se adoptan las Buenas 
Prácticas de Laboratorio para Laboratorios de Control de Calidad de Productos 
Farmacéuticos y se dictan otras disposiciones"  (Draft Ministry of Health and Social 
Welfare Resolution "Adopting the good labora tory practices for pharmaceutical quality 
control laboratories and issuing other provisions") (92 pages, in Spanish). 
6. Description of content:  The notified draft Resolution covers the following: Purpose; 
Scope; Procedure for obtaining the certificate of compliance with good laboratory 
practices (GLPs); Certification visits; Acceptance of foreign certification; Content of the certificate; Certificate validity and renewal; Extension of scope of certificate; 
Cancellation of certification; Notification; Personnel responsible; Mandatory information; 
Mandatory registration of quality control laboratories which provide external quality control services to laboratories that manufacture medicines; Transitional provision for establishments which provide services as external suppliers; Transitional provision for 
quality control laboratories operating within manufacturing establishments; 
GLP certification for laboratories with good manufacturing practice (GMP) certification; Period of validity and Derogations. 
Technical annex. Manual of good practices for pharmaceutical quality control 
laboratories; Part 1: Management and infrastructure; Part 2: Materials, equipment, instruments and other devices; Part 3: Working procedures; and Part 4: Safety; 
GLP self-assessment and microbiology laboratories. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  To ensure product safety and protect consumer health. G/TBT/N/COL/189 
- 2 - 
  8. Relevant documents:  Artículo 245 de la Ley 100 de 1993, Título VIII del Decreto 677 
del 26 de abril de 1995 y la Resolución 3183 del 23 de agosto de 1995 del Ministerio de 
Salud  (Article 245 of Law No. 100 of 1993, Title VIII of Decree No. 677 of 26 April 1995 
and Resolution No. 3183 of 23 August 1995 of the Ministry of Health).  
9. Proposed date of adoption: 
Proposed date of entry into 
force:   Date on which the Resolution is signed. 
Six (6) months as from the date of  publication in 
the Official Journal. 
10. Final date for comments:  29 April 2013 
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and e-mail and website addresse s, if available, of other body: 
Enquiry Point: 
Contact person: Daniel Héctor Rico R. 
E-mail: drico@mincomercio.gov.co  
 puntocontacto@mincomercio.gov.co 
Tel.: (+57-1) 606-7676, Ext. 1690 
Fax: (+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 
 Ministerio de Salud y Protección Social 
Dirección de Promoción y Prevención 
Carrera 13 N° 32-76 Bogotá, D.C., Colombia 
Tel.: (+57-1) 330-5000, Ext.1266 
Fax: (+57-1) 330-5050, Ext. 1280 E-mail: bolarte@minsalud.gov.co  
Website: http://www.minproteccionsocial.gov.co  
 
Text also available at: http://members.wto.org/crnattachments/2012/tbt/COL/12_3243_00_s.pdf