Business Operation Authorization – AFE

Business Operation Authorization – AFE

For an organization to operate in the Health Products supply chain – in manufacturing, importing, storing, transporting and / or distributing activities, an organization must obtain a Business Operating Authorization (AFE) from ANVISA. To this end, it should initially require its sanitary regularization with the local – municipal or state Sanitary Surveillance, depending on the activity performed. After that, the company regularization process is carried out with ANVISA. ANVISA Resolution RDC 16: 2014 establishes the general requirements for obtaining the Business Operating Authorization.

In the context of the regularization of the company – along with the local Sanitary Surveillance and ANVISA, the operating conditions of the company are verified: physical structure / facilities, material handling flows, controls to be employed, environmental conditions, various regularizations and existence of a Quality Management, which shall comply with the requirements of Good Practices related to Health Products – by ANVISA Resolution RDC 16: 2013 and / or ANVISA Normative Instruction IN 08: 2013.

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Regulatory Framework