The top four mistakes when filing an AFE.

The top four mistakes when filing an AFE.

In this blog we will share with you the four main mistakes when applying for a Company Operating Permit with ANVISA. There are several mistakes that happen, but in this content we will emphasize the main ones, which are the regulatory nightmares of companies.


Topics of this matter:

  • What is a Company Operating Permit (AFE);
  • Incorrect company size;
  • Not separating the company's activities;
  • Wrong classification of CNAE;
  • Inspection Report with caveat;
  • Clear your doubts.

What is an Operating Permit?

The Company Operating Authorization (AFE) is a document issued by ANVISA to prove that the company is authorized and qualified to carry out its functions with medicines, pharmaceutical inputs, health products, cosmetics or sanitizing products.

Stone Okamont offers full support for the process with ANVISA, directing all stages in a simple way, reducing costs and eliminating bureaucracy.

1st Incorrect company size.

The first major problem when applying for an AFE is the incorrect size of the company, usually companies are very involved in the process that comes before the Operating Permit, that is, the Operating License. But with us, this is a nightmare when the inspection report is issued, you believe that you can apply for an AFE, but the company has not verified the size, so you need to start a whole project to reclassify the company size.

Normally, this step will involve time and money, you will need to talk to your accountant and get a brief report certificate, prepare all the documentation of size, which is a separate process, and of course, you need to know how to do the petition process so you don't waste so much time. This is one of the main mistakes when applying, where people collect the fee in the wrong postage, and much less could have been spent.

2º Do not separate the activities of the company

Do not separate the company's activities when carrying out the project, that is, file the AFE request that the company requested with at least three different activities, manufacturing, import and export, prepared in a single request. In the past, it was possible to apply for everything together, but with the evolution of ANVISA and now with the segmentation of the sectors, the activities were divided, that is, for each activity a process.

If you assemble everything in a single process, most likely you will have a big problem, or you will not have your activities accepted by ANVISA, hopefully if your process is not rejected, you will probably have a single activity and you will lose at least two collected fees.

3rd CNAE wrong framing

Third big mistake and this one is so basic, but believe me, there is a range of people who still make the wrong classification of CNAE (National Activity Code), the one that goes in your CNPJ that is normally done in the first registration with ANVISA and the frame wrong. Several people have problems with their processes because the CNAE framework is wrong. Whoever is going to manufacture health products, for example, needs to have the correct CNAE referring to that activity, many times companies have CNAEs that make no sense, simply because they forgot to change the CNAE or they petitioned with the secondary CNAE and it will be necessary to start the whole process again, including changing the CNAE.

4º Request the inspection report with caveat

And finally, this is crucial, requesting the inspection report with reservations. As soon as you finish the licensing process and receive your inspection report to file a federal project, people usually don't pay attention because they believe that the local health surveillance has given the go-ahead to proceed with the process. The main errors in the inspection report are usually the lack of activity, as it may be that you manufacture and the document is missing saying that you import, export or perform too many activities. The second error is the caveat, probably during the project you were developing, the surveillance asked you to adapt one point or another and you simply understood that you already have the report, and that you can proceed with the sequence in the process without adapting your space, so , the project and the report go to Brasilia to the National Health Surveillance Agency with reservation, and its project is not approved.

These are the four main mistakes before the publication of your Operating Authorization, with the Official Gazette of the Union and with your company.

How can we help you?

If you are having difficulties with this process to apply for your Operating Permit, contact Stone Okamont, our consultants will be delighted to serve your company.

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