Tobacco Products

Publicado em 29/10/2020 16h42

Market authorizations

All brands of tobacco products manufactured in the Brazilian territory, imported or exported, are subject to Anvisa’s approval.

The data and the information contained in the requirements for pre-market approvals presented to Anvisa do not generate an authorization number, and any publicity or promotion linked to Anvisa's pre-market approval process is prohibited.

Pre-market approvals are valid for 12 months from the date of their publication in the Brazilian Official Gazette, and may be renewed for equal and successive periods.

The commercialization a tobacco or smoking product in Brazil can only be initiated after publication in the Official Gazette.

The sale of electronic cigarettes is not allowed in Brazil.

Please note that it is not possible for foreign companies to make administrative arrangements for issuing market authorizations 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.

Applicable regulations

These are the main regulations applicable relating to tobacco and smoking products exported to Brazil:

Resolution RDC 195/2017: Packaging and advertisement
Resolution RDC 14/2012: Regulation of brand names, allegations in the packaging, addictives
Law 12.546/2011: Limitations to the advertisement of tobacco products
Resolution RDC 304/2002: Prohibits the sale of food products that simulate tobacco products or their packaging
Resolution RDC 226/2018: Online requirement for market authorization of tobacco products