Columbia

Policy

The National Institute of Food and Drug Monitoring INVIMA under the Ministry of Social Protection controls and monitors the quality and safety of the products listed in Article 245 of Law 100 of 1993 and other relevant standards for all activities associated with their production, import, marketing and consumption. The Republic of Colombia has gone through the Health care reform in October 2009 which aims to achieve full universal health-care coverage for its citizens after year 2013, under the guardianship of the Ministry of Social Protection which is a body that establishes the policies to foster the entry of people into the labour market, social security and the social protection networks and therefore be able to fulfil its protective function, especially for the most vulnerable households. The Republic of Colombia is one of the eight Amazon countries which pledged greater cooperation in efforts to protect the world's largest rainforest from deforestation and illegal mining and logging, as Columbia is one of the signatories of the 1978 Amazon Cooperation Treaty (OTCA).

Contact

Ministry of Health and Social Programs
Website: http://www.invima.gov.co/
 
Ministry of Social Protection
Carrera 13 No. 32-76, Bogotá D.C. PBX: (57-1) 330-5000
From other cities in Colombia: 01-800-0910097
Fax: (57-1) 330-5050
Citizen's Services: In Bogotá (57-1) 595-3525
From other cities in Colombia: 01-800-0952525

 

Laws & Regulations

Botanicals and botanical medicine are regulated by Decree (1995 and 1998).  In some instances, these regulations are the same as those for conventional drugs.  Most botanicals fall into over-the-counter and independent categories.  Products entering the market must have safety evidence in the form of traditional use, clinical studies or scientific research.  GMP for botanicals is the same as for pharmaceuticals.

There is presently no post-market surveillance program.

Contact

Ministry of Health and Social Programs                               
http://www.invima.gov.co/version1/

 

Standards & Guidelines

Laws and regulations on TM/CAM were first issued in 1964 in Decree 1950, and were updated and expanded in 1995, 1997, 1998 and 2001. No national programme has been issued, nor has a national office been established, and neither is planned. An expert committee on TM/CAM was established in 1976. The Instituto Humboldt, founded in 1900, serves as a national research institute in CAM.

Herbal medicine is regulated in Colombia by means of Decree 677 of 1995 and Decree 337 of 1998. The regulations established are partly the same as those for conventional pharmaceuticals, while some are separate for herbal medicines. Herbal medicines are regulated as over the counter medicines and as an independent regulatory category. Claims that are made about herbal medicines include medical, health and structure/function claims, but none are recognized by law.

No national pharmacopoeia exists, nor is one planned; in lieu of this, the United States pharmacopoeia, Codex francés and British herbal pharmacopoeia are used. The information is considered legally binding. National monographs exist, but they are not legally binding.

Regulatory requirements for manufacturing include adherence to the information contained in pharmacopoeias and monographs, the same rules of GMP as for conventional pharmaceuticals, and special rules. No information on control mechanisms is available. Safety assessment requirements include traditional use without demonstrated harmful effects, reference to documented scientific research on similar products and clinical studies. Compliance with these requirements is ensured by a health registry.

Contact

Ministry of Health and Social Protection
Address: Cra 13 # 32-76 Bogota D.C.
PBX: (57-1) 3305000 and toll-free from other cities: 018000-910097
Fax: (57-1) 3305050
Citizen for labor and health consultations: From Bogotá: (57-1) 5953525.
Toll free from other cities: 018000-952525
Website: http://www.minproteccionsocial.gov.co/Paginas/Default.aspx