AFE stands for “Autorização de Funcionamento,” which means operating authorization in Brazil. It is the ANVISA’s approval to undertake Operations involving medications or pharmaceutical substances in Brazil.

Obtaining an operating authorization is mandatory for companies that:

• store, distribute, package, ship, export, extract, manufacture, fractionate, import, purify, repackage, synthesize, transform, and
• transport medicines and pharmaceutical ingredients intended for human use, as well as health products, cosmetics, personal hygiene products, perfumes, sanitizing products, and the filling of medicinal gases

AFE is a critical multi-step process that requires multiple document submissions to ANVISA. As per the guidelines given by the ANVISA, it takes around thirty (30)-sixty (60) calendar days to issue an AFE, which again varies with the type of the products and the documentation queries. It is very important to renew and update the AFE in a timely manner to smoothen the functioning of a pharmaceutical organization in Brazil.

If an AFE is not issued, the ANVISA has the right to charge a penalty and stop all operations in the country. AFE is granted only for one (01) class, except for the AFE of medicines and pharmaceutical ingredients, which make up the same AFE, and for cosmetics, perfumes, and hygiene products that also make up the same AFE. Therefore, for each class, there must be a separate AFE petition.

AFE is an important certification required to carry out all operations related to pharmaceutical and health-related products in Brazil. Need assistance in obtaining AFE? Our local Regulatory expert’s team in Brazil would be happy to assist you in filing and obtaining AFE certification from ANVISA. For more information, consult us today.