Operating Permits – AFE

 We offer all the support required to obtain the Brazilian Health Regulatory Agency (ANVISA) permit, handling all the steps in the process in a simple fashion, reducing bureaucracy and saving your company money. Our project planning includes generous timelines in anticipation of possible demands from the agency, so Stone Okamont will always be one step ahead in serving you at any stage. We will provide the ideal advice, so you can optimize your time without hurting your bottom line.

 We prepare for and follow through on the entire bureaucratic process. We compile the documentation, register your company in person with ANVISA, and monitor the publication of its registration in the federal government’s Official Gazette (DOU). This makes the whole process more reliable, cost-effective, efficient and safe for your company.

 Which businesses require Operating Permits (AFE)?

 As mandated by ANVISA, companies acting in the healthcare sector are automatically required to have Operating Permits (AFE) to function legally, within the rules stated by law. The main areas are shown below.

Main areas

 Health and health-related products

• Cosmetics, hygiene products, and perfumes;
• Medications;
• In-vitro usage diagnostics;
• Foods;
• Sanitizing products; household cleaning products.

Main activities

• Manufacture;
• Distribution;
• Import;
• Export;
• Storage;
• Transport.

  How does it work?

 In a nutshell, once all of the documentation has been compiled, it is evaluated by ANVISA technicians. If no demands are made, the registration is published in the Official Gazette (DOU).