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Brazil Standards: Ministry of Health Product Registration

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

Brazil Standards: Ministry of Health Product Registration

Postby bridgat » Mon Nov 17, 2008 3:44 pm

Brazilian legislation requires that the production, manufacturing, imports, exports and sales of any medical, pharmaceuticals and cosmetics products can only be handled by authorized companies, registered with the Sanitary Inspection Secretariat (SVS - Secretaria de Vigilancia Sanitaria), an agency of the Brazilian Ministry of Health. This is the Brazilian counterpart of the U.S. Food and Drug Administration. (see )

Regulatory and approval processes to enter the Brazilian market:

Imported products controlled by ANVISA (an autonomous agency the Ministry of Health), including pharmaceuticals, vitamins, cosmetics and medical products, can only be sold if:

1) the foreign company establishes a local Brazilian manufacturing unit or local office, fully responsible for its products; or

2) the foreign company appoints a Brazilian distributor, who has the registration with the SVS as an importer and distributor of the types of products being offered. Basically, any product that comes in contact with the human body and could present any potential health risk falls under these requirements.

Note: all products related to healthcare products, applied to the skin, injected into the body or even inserted into the eye (contact lens and cleaning liquids, for example), and any other having a medical application have to be registered with the month.

Documents required of local distributors for product registration, importation and sales in Brazil:

1) Alvara de Funcionamento - a trading permit granted by the state sanitary authorities. This allows the company to import, distribute, store and sell the product registered with the SVS.

2) Autorizacao de Funcionamento - a permit like the Alvara de Funcionamento, but granted by the federal government.

3) contact with a qualified technician (such as a chemist, pharmacist, engineer, etc, according to different types of industry). This is called terms of technical responsibility, signed by the professional. This document can re obtained from the regional pharmaceutical council.

4) contract with a local Brazilian laboratory to do the quality control certificate for each one of the products to be registered. This laboratory must be an OCC-Organismo de Controle e Certificacao, (control and certification laboratory) an official registered certification organization, registered with the Brazilian Ministry of Health. The company has 12 months to provide this information. The company can use any laboratory authorized by the Ministry of Health.

Product registration: product registration in Brazil is a complicated process, and has to be sought through the local office of the foreign company, or its agent. The registration is valid for five years and can be renewed continuously for the same period.

Exceptions are: diet products that are valid only for two years and can also be renewed for an additional 2-year period. The registration process must be completed within 90 days after the registration is requested. The foreign company should take a series of measures in order to guarantee its rights to the registration, including:

- apply for registration of the trademark and patent with the INPI - National Industrial Property Institute, through a local law firm.

- a solid contact with the distributor to protect the manufacturer's rights, including the ownership of its registration with the ministry of health. This should be done through a local agent.

- it is also recommended that the foreign company establish specific clauses in the contract, transferring the ownership of the registration from the agent to the manufacturer, thus minimizing risks. This transference can only occur, if the foreign company opens an office or plant in Brazil, since no registration can be transferred overseas. Transfer to another agent is extremely difficult to obtain.

- manufacturers have to disclose to the local authorities, through their agents, the quantitative and qualitative formula of their products, which should be patented in brazil, before the product is introduced into the market, and at the time of registration. This has to be described on the registration document.

Types of product registration: for registration purposes, SVS classifies the products into the following categories:

A. drugs: substances for medical or sanitary use (like sanitizing agents).

B. medicine: curative, preventive or diagnostic pharmaceutical products.

C. pharmaceutical raw materials: drugs or raw materials to be used in medicines.

D. food: prepared food products.

E. related products (correlates): in addition to the above definitions, the following products and substances used to protect health, for personal hygiene and cleanliness: medical products, cosmetics, perfumes, dietary, dental and veterinary products, insecticides and poisons.

According to Brazilian law 6360 of 1976 and its addition number 74.094 of 1977 and administrative act number 71/96, and other regulations from the Ministry of Health, products that have to be registered, in addition to medical and pharmaceutical items, are: cosmetics, child products (lotions, etc), perfumes, hygiene products.

Cosmetic products are classified according to the health risk they may present.

Grade 1 products are products with minimal risk, such as: soaps; shampoos; tooth pastes and deodorants; shaving creams; after shaving lotions; tooth brushes; dental floss; powders; beauty creams; facial masks; beauty lotions; oils; make-up; lipstick; lip pencils and liners; eye products; and perfumes.

Grade 2 products are products that present potential risk, such as: hair colors; hair lighteners; hair perming and straighteners; products for hair and scalp treatment (anti-dandruff shampoos); chemical depilatories; insect repellents;
And products for children.

Although the same documentation is required for grade 1 and 2 products, the registration of grade 1 products is much faster and simpler than the registration of grade 2 products.

Documentation needed for registration: the essential basic documents required from the local agent of the foreign company for the registration of products in Brazil are:

A) application form obtained from the Brazilian Ministry of Health;

B) original copy of the machine stamped bank slip, which serves as proof of registration fee payment;

C) trade permit ("Alvara de Funcionamento") issued by the state authority to the manufacturer's distributor;

D) same type of document ("Autorizacao de Funcionamento"), issued by the federal authority to the manufacturer's distributor;

E) document showing the technical responsibility of the distributor/ manufacturer, issued by the certification entity;

F) technical report on the product, informing the components of the formula, instructions, directions, cautions, etc;

G) label sample, brochures, pertinent information about the products, all translated into Portuguese;

H) for products not clearly mentioned on the Brazilian law, it is mandatory to provide information about their utilization, in order to demonstrate its efficacy and safety;

I) copy of the registration granted to the products at the country of origin (or copy of the free sale certificate);

J) copy of legal document, by which the manufacturer authorizes its distributor to trade and distribute the products. If a medical equipment, all documents showing product safety, country of origin, detailed (Detailed view) of the equipment inner parts and user manual, have to be presented for registration.

Note: among the above requirements, special attention should be paid to the technical report. This is mentioned in administrative act 71/96, which requires from the cosmetics, vitamin, and pharmaceutical manufacturer the following:

- the complete description of the product's formula, with all the components specified by their chemical designation, and the quantities of each one of them expressed in the metric system; the functional role of each component, and its function as integral part of the formula;

- name the components according to the pharmacopoeia standards, Brazilian and international compendia or attached bibliography, discussing the component and pertinent literature, including safety rules and efficacy. This information must be translated into Portuguese.

Product registration often takes more than one year. However, should the process take longer than three months importers and producers have legally used the protocol number provided by the sanitary inspection secretariat to distribute their products in Brazil, they may conduct business under a temporary court order. However, by doing so they assume the risk of product liability claims, if their products are found to be unsafe by the secretariat.

It is advisable that the local U.S. exporter's representative use established product registration agents, particularly if the representative is new to the market or does not have adequate knowledge of this process (which can be complicated). U.S. exporters can obtain additional information and local contact agents through ABPVS, Brazilian Sanitary Inspection Professionals Association.
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