AFE ANVISA Who needs this authorization?

1. What is a Business Permit?

Obtaining the Company Operating Authorization (AFE) is the last regulatory step for your company. This step is carried out with the National Health Surveillance Agency and allows the operation of your establishment.

It is essential to emphasize the importance of the Company Operating Authorization. Starting to operate without this license constitutes a health infraction and may result in a warning, interdiction, cancellation of authorization and license and/or fine.

3. Who needs an Operating Permit?

The Company Operating Authorization (AFE) is required from companies that carry out storage, distribution, packaging, dispatch, export, extraction, manufacturing, fractionation, import, production, purification, repackaging, synthesis, transformation and transport of medicines and supplies pharmaceuticals intended for human use, health products, cosmetics, personal hygiene products, sanitizing products, biological products and bottling or filling of medicinal gases.

4. Who does NOT need an Operating Permit?

Companies that do not need a Company Operating Permit are:

• Branches that only perform administrative tasks, without storage, as long as the head office has AFE.
• Retailer of cosmetics, personal hygiene products, fragrances and sanitizers;
• Companies dedicated exclusively to the manufacture, distribution, storage, packaging, export, fractioning, transport or import of raw materials, components and ingredients that are not subject to special control and are used in the manufacture of hygiene products, cosmetics, perfumes and sanitizers;
• Companies that only install, maintain and provide technical assistance to health equipment;

Observation:

AFE is not issued by ANVISA in the case of food companies. Every establishment carrying out activities in this area must have a prior license from the state, local or municipal health authority. To this end, the interested party should contact the health inspection body in their region, to obtain information about the necessary documents, as well as the health legislation that governs the products and the proposed activity.

How can we help you?

Stone Okamont quickly and economically performs the entire process for your company to obtain this authorization from ANVISA. Don't waste time with bureaucracy!