Regulation of products


 

General information on pre-market approvals

The pre-market approval is the legal act that recognizes the suitability of a product to the Brazilian sanitary regulation, and it is given by Anvisa. It is a control measure prior to the commercialization of the product, being used in the case of products that could present possible health risks.

Anvisa requires pre-market approvals only for the categories of products that are considered to be of greatest health risk. Some categories of products subject to health regulation are exempt from the need of obtaining pre-market approvals, because they represent a lower health risk, as established in Article 41 of Law 9.882/1999.

Pre-market approvals are published in the Official Gazette and this publication is sufficient to prove the authorization given by Anvisa, exempting the subsequent issuance of any documents, such as certificates or declarations.

After publication in the Official Gazette, the product is authorized to be marketed throughout the Brazilian territory. The marketed product must necessarily correspond to what has been evaluated and approved by Anvisa, and no changes are allowed without prior authorization from the Agency, as established in Article 13 of Law 6360/1976.

Please note that it is not possible for foreign companies to make administrative arrangements for issuing of pre-market approvals directly with Anvisa. Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.