Do I need a Company Operation Authorization (AFE, in Portuguese)?September 15, 2022
If you own a company that operates in the health, cosmetics, sanitizing and pharmaceutical industries, the Company Operation Authorization (AFE) is one of the steps in your company’s regularization process. Among a series of norms and standards, it regulates safety in facilities, control of handling and transport, ensuring safety for the consumer, established through regulations.
AFE is a document issued by the Brazilian Health Regulatory Agency (Anvisa), which authorizes the company, institution or body to start its activities. For this, it is necessary to comply with the technical and administrative requirements determined in Anvisa’s specific regulations. In addition to indicating legalization, the AFE is also an indication of the quality of your company.
According to Law nº 6.437/1977, the company that does not have the AFE is subject to the penalty of warning, interdiction, cancellation of authorization and license and/or fine. It must be requested before the opening of the company, and the company can start activities only after the request is granted.
Which companies need a Company Operation Authorization?
As it is an essential authorization for the final safety of the consumer, any and all companies in the segment of medicines, pharmaceutical inputs, health products, cosmetics, personal hygiene products, perfumes and sanitizers need the authorization. And in all links of the production chain: logistics, distribution, production and cultivation (in the case of plants that may originate substances subject to special control)
Now, if your company only works with retail trade of health products for lay use or is a branch that only performs administrative activities (except storage, as long as the head office has the AFE) you don’t need to. Retail stores of perfumes, cosmetics, personal hygiene and sanitizing products, establishments that only work with products that are not part of the special control framework and companies that only work in the installation, maintenance and technical assistance of health equipment also do not need.
How to apply for AFE?
First of all, in order to obtain the AFE it is necessary to obtain the operating authorization from the competent local health agency. Only then, the process can be started at Anvisa. The waiting time has decreased significantly in recent years. After carrying out all the steps of the process, Anvisa takes between 30 and 90 days to analyze the request, but there is no exact deadline, due to numerous internal and external factors that can interfere.
It is mandatory to obtain the Company Operation Authorization, but it is not mandatory for the company to have the AFE Certificate, since the publication of the Company Operation Authorization in the Official Federal Gazette (DOU, in Portuguese) already proves its regularization.
The sooner you start the Company Operation Authorization (AFE) process, the faster it will be up and running. And, although the regularization process is complex, you can count on the professionals at Licempre, specialist in regulatory processes.
The regularization process for AFE is complex and detailed, but it can be carried out more quickly when your company has the help of matter experts. And, to be successful, you can count on Licempre. Our company has already been successful in thousands of processes both for the regularization of companies and regularization of products. Contact us and request a quote.