DIFFERENCE BETWEEN OPERATING AUTHORIZATION (AFE) AND HEALTH LICENSE

The Business Operating Authorization (AFE) is a crucial document issued by the National Health Surveillance Agency (ANVISA), which is the regulatory body at the federal level. The main purpose of the AFE is to grant permission for companies to operate in activities involving products of health interest, ensuring that they follow the guidelines and are under the strict supervision of ANVISA.

The AFE is a requirement for a wide range of companies that operate in various stages of the production and commercial chain of specific products. This includes industries, distributors (wholesale trade), importers/exporters, transporters, warehouses and logistics operators, as well as pharmacies and drugstores. The AFE is mandatory for products such as medicines and pharmaceutical inputs (intended for human use), health products (materials and equipment), cosmetics, personal hygiene products, perfumes, household cleaning products and in vitro diagnostic products.

The issuing body of the AFE is ANVISA, a federal agency, and its scope is nationwide. This means that the AFE authorizes the company to operate throughout the Brazilian territory in the activities and with the products specified.

The Health License, sometimes called a Health Permit, is a document issued by the local health surveillance agency, whether municipal or state. This document certifies that the physical establishment meets the appropriate and necessary hygienic and sanitary conditions for its operation, in accordance with the health standards in force in the locality. Its primary purpose is to safeguard public health, ensuring that the environment where the activities are carried out does not present risks to the population, whether in the handling of food, the provision of health services or in other operations that may impact hygiene and safety.

The diversity of businesses and services that fall under this requirement is notable, covering, for example, activities related to products of interest to health (food industries, packaging, health products, cosmetics, cleaning products, medicines; wholesale and retail trade of these products, such as hypermarkets, bakeries, butchers, pharmacies, snack bars; and transportation and storage services for health-related products).

Activities are classified into three risk levels, which directly impact the licensing process. Risk I (Low) activities are exempt from health licensing, as is the case for some Individual Microentrepreneurs (MEI). Risk II (Medium) activities are subject to licensing, but do not require prior inspection at the establishment, based on declarations and documents. Risk III (High) activities require document analysis and prior on-site inspections, due to their greater potential for health risks.

Even if a company deals with federally regulated products, local licensing ensures that the physical space itself is safe. This also implies a dynamic regulatory environment at the local level, where companies must stay up to date on specific municipal/state requirements and their risk classifications, which may change.

Although distinct, the AFE and the Sanitary License are not mutually exclusive; in fact, many companies require both. The fundamental difference lies in the issuing body, the level of coverage and the main focus of each.

The need for both documents arises from the division of regulatory powers in Brazil. ANVISA ensures the quality and safety of products on a national scale, while local Health Surveillance agencies ensure that the physical establishments where these products are handled or services are provided meet the specific sanitary conditions of that location.

It is important to demystify some points about obtaining these documents. A common misconception is that having a waiver of the local Health License (for low-risk activities) means that the AFE is not necessary. The truth is that the waiver of the local Health License (Risk I) does not exempt the company from the need for an AFE, if it operates with products or activities regulated by ANVISA. The requirements are independent in their origin, although interconnected in their process for some categories.

This complexity highlights a critical challenge for companies: they cannot assume a linear, one-size-fits-all path to obtaining these permits. The specific type of product, activity, and associated risk determines the precise sequence and interaction between federal and local agencies.

Operating a business without the proper Operating Authorizations (AFE) or Health Licenses constitutes a serious health violation, subjecting the company to a series of severe penalties that can seriously compromise its continuity. In addition, the company may face the definitive cancellation of the authorization and license to operate in the regulated sector, and irregular products or products manufactured/distributed without the proper authorizations may be seized, destroyed and discarded, generating significant financial losses.

On the other hand, regulatory compliance goes beyond a mere legal obligation, becoming a competitive and strategic differentiator that adds value and drives your company's growth. Adherence to standards helps prevent risks and reduce costs, avoiding fines, bans and lawsuits, and minimizing exposure to legal and operational risks. In addition, implementing compliance processes often optimizes internal workflows, resulting in greater operational efficiency and cost reduction.

The way compliance is perceived has evolved significantly, from a defensive and costly obligation to a proactive and strategic investment. This shift is evident in the way the benefits of compliance are described, going far beyond simply avoiding penalties to include reputational enhancement, increased competitiveness, improved operational efficiency, fostering innovation and business sustainability. This perspective makes regulatory consulting services more attractive as a strategic investment rather than just a necessary expense, highlighting the return that regulatory expertise can generate.

Stone Okamont positions itself as an essential strategic partner for companies seeking safety, efficiency and peace of mind in their regulatory journey. We have in-depth knowledge of ANVISA regulations for AFE and the requirements of local Health Surveillance Agencies (municipal and state) for Sanitary Licenses. At Stone Okamont, we simplify the bureaucratic steps, from the initial analysis of the need for AFE or Sanitary License to the ongoing monitoring of processes with the competent agencies.

With Stone Okamont taking care of the regulatory aspects, your company can focus its resources and energy on what it does best: innovating, growing and serving its customers, without diverting its focus to bureaucratic complexities. Get in touch and learn more about our services.