Difference between AFE and Sanitary License: What your company needs to know?

The Company Operating Permit (AFE) is a national document issued exclusively by the Brazilian Health Regulatory Agency (Anvisa). Its function is to authorize the company's activities before the federal regulatory agency. In other words, the AFE is the permission for your company to manufacture, import, distribute, store, or sell specific products subject to health surveillance throughout the country.

It is mandatory for companies that work with products such as medicines, cosmetics, food (in specific cases), health products, sanitizers, and personal hygiene products. The evaluation for granting the AFE focuses on the company's compliance with legal and technical requirements, rather than on a physical analysis of the premises. It is important to note that, although there is no formal annual renewal, the AFE must be revalidated annually by paying fees to Anvisa.

I WANT MY OPERATING PERMIT

The Sanitary License (or Sanitary Permit) is a local document issued by the Health Surveillance Agency of your municipality or state. Its purpose is entirely different: to certify that the physical establishment meets the appropriate conditions of hygiene, safety, and structure to operate.

The issuance of this document almost always involves a technical inspection of the premises, where items such as cleanliness, pest control, proper storage, flow of activities, and safety are checked. The requirement for a Health Permit is very broad, covering everything from restaurants and industries to beauty salons and food retailers, regardless of whether they also need an AFE. Unlike the AFE, the Health Permit usually has a defined validity period (such as one year) and needs to be renewed periodically.

I WANT TO OBTAIN MY SANITARY LICENSE

For clarity, the main distinctions are summarized below:

The need for one, the other, or both documents depends directly on your business activity:

• You only need a Health License: Businesses such as restaurants, bakeries, beauty salons, or fresh food retailers generally only need a local license.
• You need both the AFE and the Health License: This is the most common situation for the audience of this article. A food industry, cosmetics manufacturer, drug distributor, or veterinary product importer will need both authorizations. The License certifies that the factory or warehouse is in good condition, and the AFE authorizes the handling and marketing of regulated products.
• Correct order: The safest and most efficient process is to first obtain the local Health License and, with it in hand, file the AFE application with Anvisa. Trying to do it the other way around can lead to rework and delays.

A serious and common mistake is to believe that possession of the Health License eliminates the need for AFE for companies that deal with regulated products. This is not true. Both requirements are independent and complementary.

I WANT MY LICENSE WITHOUT THE PAPERWORK

Understanding and obtaining the correct licenses goes far beyond avoiding fines and interdictions. It is the basis for operating with credibility, legal certainty, and competitiveness in the market. The complexity of this process, which involves multiple agencies and specific legislation, makes consulting with a specialist not an expense, but a strategic investment for your business.

Stone Okamont acts as a regulatory partner for companies that cannot take risks. Our specialized team is well-versed in Anvisa's requirements for AFE and local health agencies' requirements for licensing, simplifying all the red tape. With us, your company is guaranteed to enter and operate in full compliance with the market, allowing you to focus on your core business, innovation, and sustainable growth.

Contact Stone Okamont and turn regulatory complexity into a competitive advantage for your company.