Company Operation Authorization

What is it?

The Company Operation Authorization (AFE) is the second regulatory step for the success of your business. It is a document issued by the brazilian National Health Surveillance Agency (ANVISA) to prove that the company is authorized and qualified to perform its functions.

To obtain the Company Operation Authorization (AFE), we offer all the support for the process with ANVISA, directing the procedure in a simple way, reducing costs and eliminating the bureaucracy. Click on the link and ask for your budget.

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What is ANVISA?

ANVISA (National Health Surveillance Agency) is an agency linked to the brazilian Ministry of Health. Its purpose is to protect the health of the population, being responsible for the inspection and monitoring the products and services subject to Health Surveillance, as well as control of ports, airports, borders and customs.

Who does this service apply to?

Companies that wish to manufacture, distribute, store, transport, import or export medicines or pharmaceutical supplies also need a Company Operation Authorization (AFE).

Company Operation Authorization (AFE) is mandatory in several sectors of products subjected to the brazilian National Health Surveillance (ANVISA):

Health products (materials and equipment),
Cosmetics,
Medicines,
Diagnostics for in vitro use,
Hygiene products and perfumes,
Foods,
Sanitizing and cleaning products.

Main activities that need Company Operation Authorization (AFE):

Manufacturing;
Distribution;
Import;
Export;
Store;
Specifications on the Anvisa Operation Authorization for Drugstores

(To obtain the Anvisa Operation Authorization for Drugstores and Pharmacies, in addition to the regular Company Operation Authorization (AFE), Special Authorization is still required.)

Operating Permit Specifications for Carriers

(If the company is going to transport controlled medications, the Special Authorization is also required.)

What are the costs involved in obtaining a Company Operation Authorization (AFE)?

To request Company Operation Authorization (AFE), first, it is necessary to define the size of the company through its annual profit, formulate the petition with ANVISA and collect the contractual tax. The costs involved can change for each company.

If there are no more pending requirements, the approval will be published in the brazilian Federal Official Gazette (DOU). Just wait for the publication to see if your Company Operation Authorization (AFE) has been approved by ANVISA.

If you still have questions about Company Operation Authorization (AFE), we have prepared a special content! See in the video below all the answers about Company Operation Authorization (AFE).

How Does The
Company Operation Authorization Work?

After gathering all the documentation, the company will be evaluated by technicians from ANVISA and, if there are no more pending requirements, the approval will be published in the brazilian Federal Official Gazette (DOU). To verify if your Company Operation Authorization has been approved, you must wait for the publication.

To answer all your questions, we prepared a special content: See the following video for all the answers about Company Operation Authorization.