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)