PRODUCT REGISTRATION

Product registration in Brazil is a laborious exercise, and has to be requested by the local office of the foreign company, or its agent (distributor).

The product 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.

According to the law, the registration process must be completed within 120 days.

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.

Note:

The foreign company does not need to have a local presence in Brazil to apply for trademark and patent. It can be done directly from the country of origin. The company has 03 years after the trademark or patent was granted to launch its product in the market.

♦ A solid contract with the distributor to protect the manufacturers rights, including the ownership of its registration with ANVISA.

♦ It is also recommended that the foreign company establishes specific clauses in the contract, transferring the ownership of the registration from the agent (local distributor) to the manufacturer, thus minimizing risks. This transfer can only occur if the foreign company opens an office or plant in Brazil since no registration can be transferred overseas. This transfer of ownership of the registration from the agent to the manufacturer is very important because it would be extremely difficult to transfer it from one agent to another. After the Decree 3.961/01, the transfer of a product registration from an original owner to different companies will be not allowed if the company does not prove the following: dis-solution of partnership; joint venture; incorporation of one company by another; inheritance and change of the company’s name (Art. 23, VII).

♦ Manufacturers have to disclose to the local authorities, through their agents (local distributor), 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.

Note:

In this case, the company can apply for the benefits of the “confidentiality term” at the very moment to disclose their trade secret to ANVISA.

TYPES OF PRODUCT REGISTRATION

For registration purposes, ANVISA classifies products in the following categories:

1. Medicine Products (Drugs): for human use, their active substances and other inputs;

2. Cosmetics, Personal Hygiene Products and Perfumes;.

3. Pharmaceutical Raw Materials: drugs or raw materials to be used in medicines

4. Food: Including beverages, bottled waters, food additives;

5. Household products;

6. Sets, Reagents and Inputs Intended for Diagnostics:

7. Health Product: Medical-hospital, Odontological and Hemotherapic equipement and materials and those intended for laboratory and image diagnosis;

8. Immunobiologic materials and theirs active substances, blood and hemo-derivates;

9. Human and veterinary organs and tissues;

10. Cigarettes, cigars, and smoky product and,

11. Any product likely cause health risks, obtaining from genetic engineering, and from any other procedure subject to sources of radiation.

MEDICINE PRODUCTS (DRUGS):

Classification:

New Medicine Product. Innovative product that has patent protection whose efficacy, safety and quality have been scientifically proven and identified by its brand.

According with Article 12, Law 6.360/76, the Agency has 90 days to conclude the registration process. However, product registration process often takes more than three months.

Similar Product which contains the same active principle or principles in the same concentration with the same pharmaceutical form, manner of administration, posology and therapeutic, preventive or diagnostic indication as the reference medication registered with the Agency, and permitted to differ there from only in terms of characteristics related to the size and shape of the product, expiry date, packaging, labeling, excipients and its contents, and should always be identified by its trade name or brand. Produced after expiry patent protection.

According to Article 21, Law 6.360/76, the Agency has 120 days to conclude the registration process. However, product registration process often takes more than three months.

Generic Product. Medication similar to a reference product or innovative product with which it is intended to be exchangeable, generally produced after the expiry or waiver of patent protection or other exclusive rights, with its efficacy, safety and quality having been scientifically proven, and named in accordance with the Common Brazilian Name Listing (DCB) or the Common International Name Listing (DCI).

According to Article 12, Law 6.360/76, the Agency has 90 days to conclude the product registration process.

Note:

Brazil does not have yet an OTC (Over the Counter Product). Thus, sometimes is very hard to classify an OTC product with the Brazilian legislation. Most of them are considered by the Brazilian legislation as a pharmaceutical product or a cosmetic product.

COSMETIC PRODUCT

Classified according to the health risk they may present, hence the need to register (or exempt) certain products. 
  

COSMETIC NO-RISK OR RISK 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.

This type of product no longer needs registration, and do not need to pay the administrative fees. However, companies must notify the Agency by using the appropriate form while the product can only be launched on the consumer mar-ket 30 days after this notification has been sent.

COSMETIC RISK 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.

The company must register the product, pay the administrative fees and wait for the registration approval.

Note:

The relevant classification criteria have been defined on basis of product usage purposes, affected body areas, directions for use and precautions to be taken when using such products.

HOUSEHOLD PRODUCTS:

Registration is no longer needed for products ranked as Non Risk or Risk I, which are covered by the same comments as those mentioned for cosmetics.

The registration shall be effected on basis of the evaluation and management of the involved risks.

The following aspects shall be taken into consideration when evaluating such risks: the toxicity of the substances and their concentration in the product; the purpose of use; the conditions under which they shall be used; the occurrence of previous problems; the population likely to be exposed to such products; the exposure frequency and its duration and the form of product presentation. 

 
 MEDICAL PRODUCTS

Classification:

Diagnostics Equipment; Therapy Equipment; Equimpment for Medical or Hospital Support; Disposable Articles and Materials; Implant Articles and Materials; Material for Medical or Hospital Support; Material or Article for Fitness, Training, Beauty or Esthetical Treatment and All other Accessories of Miscellaneous Products.

Note:

ANVISA is granting registration for families of medical products (Resolution/ANVISA/ 185/01).

Certification of Imported Electro-medical Risk II and III: Follows the same rules for the national Electro-medical products. If the imported product is already certified at the home country, the extension of it is possible to Brazil as long as it could be proven that the certifying criteria used at home country is considered similar to the Brazilian NBR 1601, by the Brazilian Certifying Organization.