How to regularize a company at ANVISA?

What is company regularization at ANVISA?

The process of registering a company with ANVISA requires that your company be appropriate to act in accordance with the obligations and rules of this body.

Therefore, we understand that without authorization the company will not be able to operate regularly as it will not be able to obtain the necessary approval to comply with the Regulation of Products, whether they are produced nationally or imported.

How to register my company with ANVISA?

The first step in the process of registering an entity is to apply for a Local Operating License. With this, the Local Sanitary Surveillance System (Visa), which can be municipal or state, depending on the location of the development, issues the Local Operating License.

Thus, issuing the license at the municipal or state level will depend on the actions of each municipality or state in relation to health surveillance.

Therefore, before acquiring the Local Operating License, the company must go through a series of procedures, including inspection by the local health inspector. It is necessary to obtain the Company Operating Authorization (AFE) after acquiring the Operating License.

What is the Company Operating Permit?

The Company Operating Authorization (AFE) is a federal document conceived together with the National Health Surveillance Agency (ANVISA), it allows you to carry out your activities associated with the cosmetic, health, sanitizing and pharmaceutical products sector, such as drug companies, drugstores, pharmacies and pharmaceutical supplies.

The AFE Certificate allows the company to act with its products in accordance with Brazilian laws. The AFE is part of the regulatory process, bringing together several documents, one of which is the Local VISA Technical Report.

This report must be delivered without pending issues and with satisfactory status so that it is possible to continue the Company's Operating Authorization and be regularized with ANVISA.

Which companies do not need AFE?

The Operating Authorization is not required from some companies, that is, the following are classified as exempt from this certification:

I - Miscellaneous sale of products for human use

II - Branches that only carry out administrative activities without collection as long as the mother has AFE

III - Retail sale of cosmetics, personal care products, fragrances and disinfectants

IV - Companies that only carry out activities related to the production, distribution, storage, embalming, export, fractionation, transport or import of raw materials, components and imports that are not subject to special controls and are used in the manufacture of health products, beauty, personal hygiene, perfumes and disinfectants.

V - Companies that install, maintain and provide technical assistance only for medical equipment.

How can I register my company securely?

To regularize your company safely, Stone Okamont has been operating in the market for over 25 years in the regulatory market, through highly qualified professionals in the regularization of companies and products.

You can ask our experts any questions about regulatory processes. Contact us and ask your questions.