G/TBT/N/COL/221  
28 October 2016 
(16-5913) 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 So cial (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 f rom above:  
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) : In vitro  
reagents fo r research, orphan in vitro  diagnostic reagents, analytical grade in vitro  
reagents, analyte -specific reagents, and reagents for general laboratory use 
(30.02.10.33.00, 30.02.90.20.00, 30.06.20.00.00, 38.21.00.00.00, 38.22.00.90.00).  
5. Title, number of p ages and language(s) of the notified document : Proyecto de 
Resolución del Ministerio de Salud y Protección Social "Por la cual se establece el 
reglamento técnico sobre los requisitos que debe contener la etiqueta de los reactivos in 
vitro para investigació n, in vitro huérfanos para diagnóstico, in vitro grado analítico, analito 
específico, y los reactivos de uso general en laboratorio, que sean utilizados en muestras 
de origen humano"  (Draft Resolution of the Ministry of Health and Social Welfare 
establishi ng the technical regulation on the labelling requirements for in vitro  reagents for 
research, orphan in vitro  diagnostic reagents, analytical grade in vitro  reagents, analyte -
specific reagents, and reagents for general laboratory use, which are used in sam ples of 
human origin) (5 pages, in Spanish)  
6. Description of content : The notified text establishes the labelling requirements for in 
vitro reagents for research, orphan in vitro  diagnostic reagents, analytical grade in vitro  
reagents, analyte -specific r eagents, and reagents for general laboratory use . It covers the 
following : Purpose and scope ; definitions ; general labelling requirements ; specific labelling 
requirements ; declaration of conformity ; conformity assessment procedure ; authorization 
for deplet ion of stocks of labels and use of adhesives ; review and updating ; inspection, 
monitoring and control ; and period of validity.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : To protect human life and health, while pr eventing practices likely to mislead 
consumers.  
8. Relevant documents : Law No. 09 of 1979 ; Decree No. 3770 of 1 2 November 2 004 and 
Decree No. 2323 of 1 2 July 2 006 of the Ministry of Health and Social Welfare.  G/TBT/N/COL/221  
- 2 - 
  9. Proposed date of adoption : Date on which t he Resolution is signed . One year after 
publication in the Official Journal.  
Proposed date of entry into force : Date on which the Resolution is signed . One year 
after publication in the Official Journal.  
10. Final date for comments : 25 January 2 017 
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@m incit.gov.co ; puntocontacto@mincit.gov.co  
Tel.: +(57-1) 606 -7676, Ext. 1690  
Website: http://www.sical.gov.co/reglamentos -tecnicos ; 
http://www.mincit.gov.co/publicaciones.php?id=33051  
Ministerio de Comercio, Industria y Turismo  (Ministry of Commerce, Industry and Tourism)  
Dirección de Regulación  (Regulation Department)  
Tel.: +(57-1) 606-4775 
Calle 28, N° 13A - 15, tercer piso  
Bogotá, D.C . Colombia  
Ministerio de Salud y Protección Social  (Ministry of Health and Social Welfare)  
Dirección de Medicamentos y Tecnologías en Salud  (Department of Medicines and Health 
Technologies)  
Carrera 13 N° 32 - 76 
Bogotá, D.C., Colombia  
Tel.: +(57-1) 330 -5000, Ext. 1340  
Email: asantana@minsalud.gov.co  
Website: https://www.minsalud.gov.co/  
Also available at: 
https://members.wto.org/crnattachments/2016/TBT/COL/16_4487_00_s.pdf