G/TBT/N/COL/219  
23 May 2016  
(16-2787)  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 telephon e 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 [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): 
Phytotherapeutic products (30.04.90.29) 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
Decreto del Ministerio de Salud y Protección Social "Por el cual se reglamentan los regímenes de registros sanitarios, de vigilanc ia y control sanitario y publicidad de los 
productos fitoterapéuticos" (Draft Ministry of Health and Social Welfare Decree "Regulating 
the sanitary registration, sanitary surveillance and control and advertising systems for phytotherapeutic products") (25 pages, in Spanish)  
6. Description of content: Scope; Definitions; Pharmacopoeias and officially approved 
reference texts; Classification of phytotherapeutic products; Colombian Vade-mecum of 
Medicinal Plants; Good manufacturing practices; Quality control; General provisions 
governing the sanitary registration system; Sanitary registration for medicinal plant-based pharmaceutical preparations; Sanitary registration for traditional phytotherapeutic 
products; Containers, labelling and packaging for phytotherapeutic products; 
Phytotherapeutic product brand names; Language of wording on labels, tags, packaging and inserts; Sanitary control and surveillance system; Notification and period of validity. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: Transparency 
8. Relevant documents: Ministry of Health Decree No. 677 of 26 April 1995; Ministry of 
Social Welfare Decree No. 162 of 22 Janua ry 2004, No. 2510 of 3 September 2003, 
No. 2266 of 15 July 2004 and No. 3553 of 28 Octobe r 2004; Ministry of Health Resolution 
No. 2514 of 11 July 1995 and No. 3131 of 6 Au gust 1998; Ministry of Social Welfare 
Resolution No. 886 of 29 March 2004 and No. 5107 of 29 December 2005; Vademécum 
Colombiano de plantas medicinales , British Herbal Pharmacopoeia, British Pharmacopoeia, 
Real Farmacopea Española , and pharmacopoeias in effect for the European Union, United 
States (USP), Brazil, Mexico, and France (French Codex); Plantas Medicinales 
Iberoamericanas  - Gupta M.P-CYTED; WHO MONOGRAPHS ON SELECTED MEDICINAL 
PLANTS; Plant Drug Analysis - Wagner; NAPRALERT; Flora Medicinal Colombiana, Especies 
Vegetales Promisorias . G/TBT/N/COL/219 
- 2 - 
  9. Proposed date of adoption: Date on which the Decree is signed. 
Proposed date of entry into force: Six months from the date of publication in the 
Official Journal.  
10. Final date for comments: 19 August 2016 
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:  
Enquiry point: 
Contact person: Daniel Héctor Rico R. Email: drico@mincit.gov.co ; puntocontacto@mincit.gov.co  
Tel.: +(57-1) 606-7676, Ext. 1690 
Ministerio de Comercio, Industria y Turismo Dirección de Regulación 
Calle 28, N° 13A - 15, tercer piso 
Bogotá, D.C. Colombia Website: http://www.mincit.gov.co/publicaciones.php?id=33051  
 
Ministerio de Salud y Protección Social 
Dirección de Medicamentos y Tecnología en Salud Carrera 13 N° 32 - 76 
Bogotá, D.C., Colombia 
Tel.: +(57-1) 330-5000 Email: aherediav@minsalud.gov.co  
Website: http://www.minpro teccionsocial.gov.co/ 
 Also available at: https://members.wto.org/crnattachments/2016/TBT/COL/16_1968_00_s.pdf