Anvisa updates form for Business Operation Authorization and Special Authorization

Since last Thursday, October 3^rd, the forms used to request the Business Operating Authorization (AFE) and Special Authorization (AE) in the Solicita system will undergo an update. This change will affect requests for the granting of authorizations provided for in Collegiate Board Resolutions (RDCs) 16/2014, 275/2019, 345/2002, 346/2002 and 61/2004.

Important: Due to the update, matters related to requesting these authorizations may be temporarily unavailable between 6pm on October 2^nd and 6pm on October 3^rd.

With this new update, the information that previously needed to be sent as an attachment will now be filled in directly in the system. This improves the process, as some common filling errors will be reduced through new Solicita features:

• Company name and address information will now be automatically extracted from the Federal Revenue of Brazil database, which avoids manual errors.
• The class type and activity selected will be adjusted according to the subject code chosen in the system, making the process more intuitive.
• The system will also notify you if the CNPJ entered already has the AFE or AE previously selected, avoiding duplication of requests.
• For pharmacies, completing the declaration required in Annex I of RDC 275/2019 can be done directly in the Solicita system, simplifying the process.

With these improvements, it is expected that the number of requirements issued during the process will be reduced, speeding up the analysis of concession requests and reducing the total time required to complete these requests.

For more details on how to correctly fill in each field on the form, consult the Solicita Manual, available at the link: https://www.gov.br/anvisa/pt-br/sistemas/peticionamento.