Authorization for Operation (AFE) is the act of competence of Anvisa that allows the operation of companies or establishments, institutions and bodies, by complying with the technical and administrative requirements contained in RDC No. 16/2014.

The company that does not have the Authorization for Operation of the competent sanitary body will commit a sanitary infraction and will be subject to the penalty of warning, prohibition, cancellation of authorization and of license and / or fine, according to the terms of Law nº 6.437 / 1977.

The Authorization for Operation (AFE) is required of companies that carry out activities of storage, distribution, packaging, dispatch, export, extraction, manufacture, fractionation, import, production, purification, repackaging, synthesis, transformation and transportation of pharmaceutical products and pharmaceutical inputs to human use, medical devices, cosmetics, hygiene products, perfumes, cleaning products and filling of medical gases.

Products considered medicines, medical devices, cosmetics, food products and cleaning products must be registered in  ANVISA unless they are exempted by some specific Resolution.