The Operation Permits (AFE) is the second step to get the regularization with the Brazilian Health Regulatory Agency (ANVISA) and be able to work with your product legally.
But what is the Operation Permits (AFE)?
The Operation Permits (AFE) is a federal document that indicates that the company is regulated by the National Sanitary Surveillance Agency.
The Operation Permits 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 them being the Technical Report of VISA Local.
This report must be delivered without problems and with satisfactory status so that it is possible to continue the Operation Permits and be regularized with ANVISA.
What happens in the Business Operation Authorization (AFE)?
In this stage, the ANVISA technicians evaluate the documents requested.
If deferred, the Operation Permits (AFE) is published in the Official Gazette (DOU).
Is it possible to regulate a product without the Operation Permits (AFE)?
The Operation Permits is essential for your company to be regulated. If the company is not regularized, its products can not be registered.
Therefore, without the AFE it is impossible to continue the product registration process.
How long does it take to get the Operation Permits (AFE)?
The average time to obtain the Operation Permits is 45 to 90 days. However, this period is not exact and may increase or decrease.
Some factors that interfere in time are the demands of ANVISA, queues of analyzes, pending (ANVISA requirements) or errors in the company documentation.
To expedite the regularization of your company, Stone Okamont follows the whole process, providing advice and consulting to optimize your time and cut unnecessary expenses, using the Zero Bureaucracy!
Who needs the Operation Permits (AFE)?
It is mandatory for any company that acts in the health area, regardless of whether the activity is manufacturing, distribution, import, export, storage, transportation or any other.
The main activities in the sectors of medicines, health products (correlates - materials and equipment), cosmetics, hygiene products, perfumes, diagnosis of in vitro use, food, sanitizing and household cleaning products.
Is it possible to add activities to the Operation Permits (AFE)?
If your company wants to add another area of regulatory activity there is a different process.
Your company will be evaluated and inspected with emphasis on the aggregate activity, ie if your company distributes a certain product for health, but now it starts to manufacture the same product, it must request an expansion of activity and go through the regulatory process with careful evaluation in the manufacturing process.
Stone Okamont can help your company pass the inspections and regulatory screens of the new aggregate activities, facilitating bureaucratic processing using the Zero Bureaucracy methodology.
Is it necessary to pay fees when requesting activity extension in my AFE?
Yes, the company must request the extension and pay the fees related to the new activity.
It is important to say that the value of the fees are relative to the size of the company, in other words, the higher the company's turnover the higher the rate to be collected.
The process can be somewhat complex, laborious and full of details, so Stone Okamont is here to help your company achieve its goals!
