This form is to be used for the registry of the DIFA Holder not stablished in Brazil (i.e., with no CNPJ number). Please fill the Registry Form, sign and send it to difa.holder@anvisa.gov.br with the subject [Registry]. After registration, a DIFA Holder Number (DHN) and Authorized User Number (AUN) will be assigned.
The application form and its annexes templates for CADIFA-related application can be submitted as one file or several files. The application form template is structured for all types of applications. Additionally, Anvisa suggests the submission of the Comparative Table (Application Form Annex 8), when required, in DOC/DOCX format.
Form for the assessment of eligibility for the optimized analysis procedure of CADIFA applications (ANNEX III of IN 289/2024), to be provided in the submition of "12283 - CADIFA - Application for optimized analysis procedure" linked to the CADIFA application,
Form to be provided in the application code "12358 - CADIFA - Mudança do Detentor da CADIFA | Change of CADIFA Holder". The change of CADIFA holder applies to corporate (spin-off, merger or incorporation) and commercial transactions (operation that results in the transfer of assets or a set of assets, without the occurrence of any corporate operation) between companies that result in the need to update data related to the holder of CADIFA, applying exclusively to cases in which the conditions and technical-sanitary characteristics of the API of the CADIFA are maintained.