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Chile Standards: Pharmaceuticals, cosmetics. pesticides

Regulations of Chile for special products, prohibitions, restrictions, labeling, documentation, etc.

Chile Standards: Pharmaceuticals, cosmetics. pesticides

Postby bridgat » Tue Nov 18, 2008 3:39 am

Regulations governing the import of cosmetics, pharmaceuticals, nutritional aids of medical use for human consumption, and pesticides for home use are contained in Decree 1876, in place since April 1997.

This Decree forces registration for all the above mentioned products, at the Instituto de Salud Publica (Institute of Public Health, ISP), an independent public agency following the norms and policies set forth by the Ministry of Public Health. Local legislation understands by cosmetics any preparation destined to be applied externally to the human body to beautify, modify the physical aspect, or preserve the normal physical chemistry conditions of the skin and its annexes.

Perfumes, eau de toilette, eau de perfume, and toiletries in general do not require registration. There is a registration fee for a cosmetic products and the registration application time frame varies from one to three months. The registration is valid for five years. This process is usually simple for U.S. products, since U.S. manufacturers are known to provide the original formulas, unlike companies from other countries.

The ISP requires that each importation be authorized after analyzing units of the shipment, which must coincide 100 percent with the analysis of the units examined during initial registration. Furthermore, if the shipment contains many different dates, each lot must be authorized and 2 units per lot must be presented. One unit is analyzed and the other is kept for 5 years.

Also, pharmaceutical specialties, cosmetics, and most biological and bio-chemical preparations may be subject to special labeling and other requirements, depending on the nature of the individual product.

Instituto de Salud Publica
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Santiago, Chile
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