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New ANVISA Scheduling System: 3 Compliance Rules You Need to Master (And the 5-Year Record Keeping Risk)

The end of the Parlatório and ANVISA’s new digital era: Understand how Ordinance 54/2021 and automation demand Compliance 4.0 to avoid rejections and ensure the legal security of your business.

The National Health Surveillance Agency (ANVISA) has taken a definitive step in its digital transformation journey by launching the New Appointment Scheduling System, formally replacing the old Parlatório. More than a simple software change, this update is a milestone in Compliance 4.0 that reorganizes the dynamics of interaction between the regulated sector and the agency.

For companies in the pharmaceutical, food, and health product sectors, mastering this new environment is not just a matter of efficiency; it is a necessity to ensure legal security and the speed of registration and post-registration processes.

The Era of Programmed Refusal: Mastering Area Selection

The new system, based on Ordinance PT nº 54/2021, brought unprecedented rigor to workflow management. The biggest historical point of friction, which generated overload and inefficiency, was the scheduling of appointments in the wrong technical area. A notorious example is the General Management of Medicines and Biological Products (GGMED), which received numerous mistaken requests.

The rule is clear: appointments requested to an area that is not competent for the subject of the hearing may be refused.

For your business, a refusal means a 100% delay in your regulatory timeline, forcing a restart of the submission cycle. Digitalization, in this context, automates refusal, transforming administrative inaccuracy into a very high cost of regulatory inaction. The key to success is prior regulatory due diligence, which precisely maps ANVISA’s Internal Regulations and ensures the correct channeling of the topic.

The 5-Year Legal Commitment: The Recording as Evidence

One of the most crucial and often overlooked aspects of the new regulation is the mandatory access and retention of the hearing recording.

Article 24 of Ordinance 54/2021 assures the individual the right to access the content of the recordings but imposes a retention period of 5 (five) years. This transforms the recording into formal and auditable documentary evidence for half a decade.

For your company, this has serious implications in terms of:

  1. Legal Security: Any verbal statement made during the hearing must be strictly consistent with the company’s official records. Discrepancies can be used in future litigations.
  2. LGPD Compliance: The storage and processing of this long-term data must be in full compliance with the General Data Protection Law (LGPD) and the Ordinance.

Managing and indexing this volume of data for such an extended period requires more than manual methods; it requires a secure RegTech infrastructure.

Post-Digitization Visibility: The Risk of “Awaiting Submission”

The new system works with detailed flows and statuses. The status “Awaiting submission” is a critical point that requires immediate attention. It indicates that ANVISA has already performed its initial analysis and is awaiting the submission of complementary documents or data from the applicant.

Failure to monitor and respond promptly to this status can paralyze the process for weeks, resulting in further delays in product launches or resolution of technical pending issues. Success in scheduling intrinsically depends on real-time monitoring of the status quo.

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.

Navigating ANVISA's new digital scheduling system?

Your Solution is Compliance 4.0: Passarini Group at the Forefront

The New ANVISA System is a gatekeeper of processes. To navigate this more rigorous environment, Passarini Group offers strategic solutions that transform these challenges into competitive advantages:

  • Strategic Pre-Hearing Consulting: Avoid programmed refusal. Our team precisely maps the technical competence for your agenda, ensuring successful scheduling on the first attempt.
  • Integrated Document Management Platform: Solve the 5-year retention challenge. Our RegTech securely stores and indexes recordings and minutes, ensuring full compliance with Ordinance 54/2021 and LGPD.
  • Proactive Regulatory Alert Service: Eliminate the risk of inaction. Receive instant alerts about status changes (“Awaiting submission”), ensuring immediate responses and keeping your process always moving.

ANVISA has digitized; your regulatory management needs to keep up. Contact Passarini Group and ensure the efficiency of the new system works in favor of your business.

contato@passarini.com.br

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