How to issue Anvisa’s AFE Certificate: step by step

The Anvisa AFE Certificate is one of the most frequently required health compliance documents in the healthcare industry. It proves that a company holds a valid Company Operating Authorization (AFE) from Brazil’s National Health Surveillance Agency. It is therefore authorized to operate in activities such as manufacturing, distributing, storing and selling drugs, pharmaceutical ingredients and health products.

For hospitals, distributors and suppliers in the healthcare ecosystem, keeping this document up to date is a condition for taking part in public tenders, registering on hospital procurement platforms and passing compliance audits. Noncompliance, in turn, can suspend entire operations and compromise the supply of critical supplies.

What the AFE is and its legal basis

The AFE (Company Operating Authorization) is the federal administrative act that legally authorizes a company to operate in activities subject to health surveillance. Without it, carrying out these activities is irregular and subject to administrative and criminal penalties.

The AFE requirement was established by Law No. 6,360/1976, which governs the health surveillance of drugs and related products. With the creation of Anvisa in 1999, by Law No. 9,782/1999, the agency gained exclusive authority to grant and oversee these authorizations.

Unlike the health permit (Alvará Sanitário), which falls under state or municipal authority, the AFE is federal in scope and mandatory for companies that carry out the following activities:

• manufacturing and quality control;

• distribution and storage;

• transportation of regulated products;

• import and export;

• retail sales (pharmacies and drugstores).

Companies that handle substances subject to special control, such as the psychotropic and narcotic drugs listed in Ordinance SVS/MS No. 344/1998, must obtain, in addition to the AFE, a Special Authorization (AE). This ordinance defines the lists of controlled substances and the obligations of the companies that handle them.

AFE and AFE Certificate: understanding the difference

These two terms refer to different things, and confusing them is common even among experienced compliance teams.

In practical terms: the AFE is the authorization; the certificate is the proof that it exists and is active.

Who needs the AFE Certificate

The certificate is required in three main contexts within the healthcare ecosystem:

Public tenders

Legal and technical qualification in bidding processes run by public hospitals, health departments and federal agencies often requires the AFE Certificate as a health compliance document.

Registration on hospital procurement platforms (B2B)

Suppliers of drugs, OPME (implants and special materials), supplies and medical equipment need to present the certificate to register in the procurement systems of mid-sized and large private hospitals. Not having the document can block registration or prevent contract renewals.

Compliance audits and due diligence

In internal audit processes, certifications such as ONA or international accreditation, and in M&A transactions in the healthcare industry, the AFE Certificate is one of the standard regulatory documents checked by compliance teams.

How to look up and issue Anvisa’s AFE Certificate

The AFE is issued and looked up through the Solicita System, Anvisa’s official platform for managing authorizations. Access requires an active gov.br account with the appropriate authentication level.

The issuing flow follows these steps:

• Access the Solicita System by logging in through gov.br.

• Find the company by its CNPJ (Brazilian company taxpayer ID) in the AFE lookup module.

• Check the registration status: the authorization must be active, with no pending issues or restrictions.

• Issue the certificate: the generated document shows the legal name, CNPJ, AFE process number, authorized activities and authorization status.

Before issuing, you need to check that the Health Surveillance Inspection Fee (TFVS) has been paid, when applicable. Nonpayment blocks issuance and can create a formal irregularity.

Anyone can look up the status of any company directly on the Anvisa portal, with no login required. Compliance teams should include this check in their supplier qualification processes.

Validity and maintaining compliance

The AFE is granted for an indefinite period. This does not mean, however, that the certificate needs no updates. It must be reissued or updated whenever there are relevant changes to the company, such as:

• a change of address or facilities;

• expansion or reduction of the classes of authorized activities;

• a change in technical responsibility;

• a change in the company’s legal representation.

Leaving this information out of date in Anvisa’s records constitutes an irregularity, even if the original AFE is active. Formal compliance depends both on the validity of the authorization and on the accuracy of the registration data.

Technical summary: Anvisa’s AFE Certificate

Health compliance as a foundation of the revenue cycle

For distributors, manufacturers and suppliers that serve hospitals, the AFE Certificate goes beyond a bureaucratic requirement. It is the credential that makes commercial operations possible in the regulated industry: without it, there is no registration on hospital platforms, no qualification in tenders and no approval in compliance audits.

For hospital managers, checking suppliers’ AFE is part of the partner qualification process and reduces the risk of disruptions in the supply of critical supplies. Keeping this control active is part of the hospital’s financial and operational governance.

Health compliance and revenue cycle efficiency are more connected than they seem: noncompliant suppliers cause delays, denials and administrative rework. Technologies that automate document management and supplier compliance checks reduce these risks systematically.

Frequently asked questions about Anvisa’s AFE Certificate

What is Anvisa’s AFE Certificate?

It is the electronic document issued by Anvisa that proves that a company holds a valid Company Operating Authorization (AFE). It is generated by the Solicita System and shows the authorized activities, the CNPJ and the status of the authorization.

Does every healthcare company need an AFE?

Companies that manufacture, distribute, store, transport, import, export or sell drugs, pharmaceutical ingredients, health products, cosmetics and sanitizing products need an AFE. Service providers without these activities may be subject only to the state or municipal health permit (Alvará Sanitário).

How do you issue the AFE Certificate?

It is issued through the Solicita System, on the Anvisa portal, by logging in with a gov.br account. The company must have paid the TFVS (when applicable) and keep its registration up to date. The certificate is generated digitally after the authorization status is checked.

Does the AFE Certificate expire?

The AFE itself has been granted for an indefinite period since 2014. The certificate, however, reflects the company’s registration status on the date it is issued and must be reissued after any relevant change, such as a change of address or technical responsibility.

What is the difference between the AFE and the Special Authorization (AE)?

The AFE authorizes companies to operate with health products in general. The AE is an additional document, required for companies that handle substances subject to special control, such as the psychotropic and narcotic drugs listed in Ordinance SVS/MS No. 344/1998.