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Brazil Standards: Pharmaceutical and Cosmetic Industries

Come here to discuss the Brazil's standards of various industry, products registration and import regulations as well as tariff information.

Brazil Standards: Pharmaceutical and Cosmetic Industries

Postby bridgat » Mon Nov 17, 2008 3:45 pm

The Anvisa web site provides continuous updated information on registration rates and newly adopted standards.

The Brazilian law 6360 of 1976 and its amendment number 74.094 of 1977 and administrative act number 71/96, and other regulations from the Ministry of Health, specify that only authorized companies, registered with the Sanitary Inspection Secretariat (SVS - Secretaria de Vigilancia Sanitaria) can manufacture, import and sell pharmaceuticals, vitamins, cosmetics and medical products. The Ministry recently announced plans to replace this agency with a new organization, Agevisa, Agency of Sanitary Inspection, modeled after the FDA. Law 6360 is the main legislation that governs the actions of the SVS - sanitary inspection secretariat and sets the rules and terms for product registration. The law states, in Article 12, that the SVS has 90 days from the date of filing for registration, to grant or deny it. According to market sources, due to a series of political and administrative difficulties over the years, about 60,000 such registration requests are pending decision at the SVS, some of them 3 to 6 years old. Because the law does not define what happens if the SVS does not grant the permission, Brazilian industry and the Ministry of Health are locked in a legal quagmire over the status of traded products that have yet to receive registration approval, but may be traded under court injunction, after 90 days, but before the SVS's final decision.

In practice, since 1976 the local industry and distributors have marketed many products based on a preliminary court orders that guarantee their right to sell the products after the 90 days term for SVS review has expired without SVS action. The pharmaceutical and cosmetics manufacturers and distributors have resorted to this practice to address inefficiencies with the SVS and to import products.

Law number 9.677 on July 2, 1998, aims to punish companies that manufacture and/or sell counterfeit or adulterated pharmaceutical products (including vitamins and related food products). Article 273, paragraph 1, states that anyone selling counterfeit or adulterated pharmaceutical and food products is subject to 10 to 15 years prison term, plus fines, without bail.

The law also states in a sub-paragraph that the following practices relating to the sale of pharmaceutical products, vitamins and cosmetics products are considered breach of this law:

Sale of a product:

A) without registration, when demanded by the sanitary authority;

B) when its formula does not match what is described on the registration document;

C) if its quality is below standards, not acceptable for sale;

D) if its therapeutic qualities are adulterated;

E) if its source is unknown;

F) if it is sourced from an organization without proper registration with the Ministry of Health.

Based on this new law, many local manufacturers and distributors are vulnerable to punishment by it, because of the regular practice of selling pharmaceutical products, (including vitamins and related Food products), without SVS registration, but under preliminary court orders, when no SVS determination has been made within the 90 day legal term. The ABPVS - Brazilian Sanitary Surveillance Professionals Association (representatives for UPS, US regulatory affairs professionals society in Washington, D.C., organized a seminar on July 23, 1998 to discuss this issue with their members and will present their position to the Brazilian Minister of Health.

Meanwhile, US companies selling vitamins and related pharmaceutical products should alert their agents and distributors in Brazil to seek legal counsel regarding this new law and consider postponing shipments until clarification is obtained.
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