Chile

Policy

In 1992, the Ministry of Health established Unidad de Medicina Tradicional y Otras Practicas Medicas Alternativas (Unit for Traditional Medicine and Other Alternative Medical Practices). This Unit is also in-charged with developing the national policy, laws and regulations that are related to TM/CAM. There are no regulations regarding claims to be made on nutritional products.  However, claims may be made on botanical medicines. Botanicals are regulated as over-the-counter medicines, dietary supplements and as specialty products.  Botanical medicines may carry health claims, are manufactured with specific guidelines, however there is no registration system. There are GMP regulations in place that are specific to herbal medicines. Traditional medicine is still prominently practiced in territories where indigenous groups have a stronger voice, principally Aymara in the north and Mapuche in the south. The Chilean government has developed and implemented the Indigenous Health System, a series of special programs to help promote, recover, and strengthen the health practices of Chile's indigenous communities.

Contact

Ministry of Health Chile             
Website: http://www.minsal.cl/

 

Laws & Regulations

There are no regulations regarding claims to be made on nutritional products.  However, claims may be made on botanical medicines.

Botanicals are regulated as over-the-counter medicines, dietary supplements and as specialty products.  Botanical medicines may carry health claims, are manufactured with specific guidelines, however there is no registration system.  There are GMP regulations in place that are specific to herbal medicines.

There is a post-marketing surveillance system for all adverse events.

In 1992, the Ministry of Health established Unidad de Medicina Tradicional y Otras Practicas Medicas Alternativas (Unit for Traditional Medicine and Other Alternative Medical Practices)  This Unit was charged with developing the national policy, laws and regulations as they relate to TM/CAM. 

Contact

Ministry of Health     
http://www.minsal.cl/

 

Standards & Guidelines

Regulation of herbal medicines began since 2002. It is known to be a separated and specialized law. Herbal medicines are regulated as over the counter medicines, dietary supplements and also as independent regulatory category. Herbal medicine may have medical and health claims. An outdated national pharmacopoeia had been replaced with alternatives including international pharmacopoeia, United States pharmacopoeia, British pharmacopoeia, German pharmacopoeia and German homeopathic pharmacopoeia. National monographs are also in production.

Regulatory requirements for manufacturing include adherence to the information in pharmacopoeias and monographs and the special GMP rules for herbal medicines. Special rule for safety assessment includes traditional use without causing harmful effects and it is based on documented scientific research on similar products. The implementation of these requirements is guaranteed by an official listing system and hygienic controls of packaging establishments and on the medicines.

As for alternative medicines practices such as homeopathy, acupuncture, naturopathy, chiropractic, the Sintergética, Flower Therapies and Apitherapy are being practiced in Chile. The less complex one includes Reiki, aromatherapy and therapeutic massage. The Ministry of Health, Undersecretary of Public Health recognizes and regulates acupuncture and homeopathy as Assistant Health Profession.

Contact

Ministry of Health Chile
Location:   Mac Iver 541, Santiago, Chile 
Website: http://www.minsal.cl/