General Information and Documents Required for the Registration of Products in Brazil.

For the purpose of exporting pharmaceutical products of any nature, cosmetics, cleaning products and foods and beverage to Brazil, the following information and documents are required:

1. A company established in Brazil must be responsible for the products and/or any problems that may arise from their sale.
1. To comply with this requirement, exporter can either set up a company in Brazil and have it legalized before the competent authorities, which can take up to 6 months with a significant initial cost; or
2. Contact an established Brazilian company, already duly authorized to operate by the Health Department and Sanitation Agency, with all required licenses and permits, which will act as importer and/or distributor of the exported goods.
2. Should exporter decide for the second option, which seems to be far more reasonable, the following documents have to be prepared and forwarded to importer in order to obtain registration before the competent authorities.
1. A Declaration (as per specific draft to be provided) authorizing importer to act on behalf of manufacturer before the competent authorities to obtain registration for each product, which have to be individually listed (not required for food and beverages);
2. Authorization to Sell each product in manufacturer’s country;
3. A report with a complete analysis of each product;
4. A copy of all packaging and labeling, including any wording;
5. The formulation for each product: all ingredients have to be both qualitatively and quantitatively precisely listed.

The Declaration with the list of products and the Affidavit shall be typed in exporter’s letterhead and all documents must be notarized and legalized up to a Brazilian Consul.

Sworn translations of the above documents have to be prepared and filed with the competent authorities, and the corresponding license shall be published in the Official Gazette of the Union in a couple of months.

Please note that all Certificates of Registration are issued in the name of the Brazilian importer, whereby a previous Agreement with a specific clause relative to the property of the registrations is essential to assure manufacturer’s rights.

The expenses for each case are as follows:

Official fees:

Pharmaceutical products: depending on the nature of each product, the official fees may vary from about US$ 400.00 to US$ 1,800.00. In order to provide you with a more precise information we need to know more about each product and its ingredients.
Cosmetics and cleaning products: US$ 400.00
Food and beverages: US$ 100.00

Our fees:

Our fees: our fees for these services are US$ 1,000.00, and we usually ask for a retainer of half this value plus the official fees.