Effective Date
Effective August 1st, 2024, Anvisa (Brazilian Health Regulatory Agency) will enforce revised administrative treatments for imported products subject to health control and inspection.
Import Licensing Process
Under these regulations, products requiring health control must undergo an Import Licensing process as stipulated in Article 8 of Law 9,782/1999 and RDC 81/2008. Anvisa has conducted a comprehensive review of Mercosur Common Nomenclatures (NCMs) for such products, resulting in updated administrative procedures.
Key Requirements for Importers
Key requirements for importers include:
- Category Selection: Importers must specify the regulatory category of the finished product, including inputs or components used in manufacturing.
- Special Cases (Food Category): Importers may select from available options if their product aligns with exceptions outlined in the regulations.
NCMs and their associated treatments will be integrated into LPCO models within the Single Foreign Trade Portal. Importers are encouraged to report any issues requiring adjustments through Anvisa's "Talk to Us" platform.
Notably, issue code 90368, related to importing goods not subject to health intervention, will be deactivated to streamline regulatory processes.
These measures reflect Anvisa's commitment to enhancing import procedures, ensuring compliance with health regulations, and facilitating smoother trade operations in Brazil.
Regulatory Impact
- Top Priority: Yes
- Type of Approval: No
- Spectrum Bands: No
- Import Changes HS Codes: Yes
- Standard Changes: No
- Product Changes: Yes
- Label Changes: No
Link to Source
Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |