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The End of Waiting: ANVISA Automates AFE and AE, Transforming Brazil’s Regulatory Routine

The Authorization to Operate (AFE) and Special Authorization (AE) are foundational documents for any company seeking to operate in a market regulated by the Brazilian Health Regulatory Agency (ANVISA), covering sectors such as pharmaceuticals, medical devices, cosmetics, and sanitizing products. Historically, the waiting time for the issuance of these certificates — even after approval — has been a bottleneck directly impacting companies’ time-to-market.

In a move that marks a significant step forward in Digital Transformation and Bureaucracy Reduction, ANVISA has announced that the issuance of AFE and AE certificates will now be carried out automatically through the Solicita system. This change represents a true revolution in the relationship between the regulated sector and the Agency, eliminating manual intervention in the issuance process and ushering in a new era of agility.

The Impact of Automation on Your Business

Automatic issuance is more than a technological upgrade — it’s a strategic factor for improving predictability and operational efficiency.

1. Immediate Agility and Predictability:

From now on, as soon as a process for granting or amending an AFE/AE is completed and approved, the certificate will be generated by the Solicita system within minutes. This is a drastic improvement compared to the previous timelines, which depended on manual verification and signing steps. For companies, this means that operations can start or expand almost instantly after regulatory approval.

2. Error Reduction and Legal Security:

Automating the issuance process minimizes the risk of human error in generating the final document. Additionally, ANVISA has implemented robust security mechanisms — including validation via QR Code, Issue Date, Code, and Hash — all available on the external consultation portal. This transparency and ease of validation strengthen the document’s legal reliability.
However, it is crucial that the submission process (the prerequisite for issuance) be impeccable and aligned with the company’s data, as the automatically generated certificate will precisely reflect the approved information in the system.

3. The Focus on Perfect Compliance:

The key takeaway from this change is that agility applies only to the issuance stage — not to the petition review itself. With the “end of the waiting line” for certificate generation, the focus now shifts even more toward the quality and compliance of the original petition. Any errors or inconsistencies in company registration or documentation will delay approval, preventing automatic certificate issuance. Excellence in data accuracy and submission quality is now more critical than ever to fully benefit from this new agility.

ANVISA: Automatic Issuance of AFE and AE via Solicita | Impact and Opportunities

Passarini Group: Your Partner in the ANVISA 4.0 Era

This ANVISA initiative reflects Brazil’s commitment to regulatory modernization. For companies looking to enter or strengthen their position in the Brazilian market, having a strategic partner who understands this new regulatory dynamic is essential.

Passarini Group is at the forefront of monitoring these transformations. Our team is fully prepared to ensure that your AFE and AE petitions (and all subsequent processes) are submitted with the precision required to take full advantage of automation efficiency.

Don’t waste time on bureaucracy — focus on scaling your business.

Contact our experts today and get your company ready for ANVISA’s new pace!

contato@passarini.com.br

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