Brazil’s Supplement Notification Deadline Just Expired: What Happens Now

By Wagner Fernandes, Licensed Pharmacist (CRF-RO 4509) · Brazil Market Insights · Published September 1, 2026 · Updated September 4, 2026
Wagner Fernandes, Pharmacist
Wagner Fernandes · CRF-RO 4509Licensed Pharmacist, Brazil · Founder, FarmaCerto
🚨 Deadline expired September 1, 2026

This just happened, and it changes the timeline conversation

ANVISA’s transition deadline under RDC 843/2024 expired three days ago. Supplements and weight-control foods that had been operating under the old local notification system were required to complete formal ANVISA notification by that date. If your brand, or a partner you’re evaluating in Brazil, is still relying on outdated guidance about “future deadlines,” that information is now obsolete.

What actually happened on September 1, 2026

Brazil’s supplement regularization model changed structurally with RDC 843/2024, in effect since September 1, 2024. It moved most supplements away from a simple local health surveillance notice (“comunicado”) to formal notification directly with ANVISA, the federal agency, based on a risk-tiered model. Products that had been operating under the old local system, and hadn’t yet completed the new ANVISA notification, had until September 1, 2026 to do so, per RDC 990/2025, which amended the original deadline.

What happens to products that missed the deadline

TrackConsequence of missing the deadline
Products requiring registration adequacyCancellation of registration
Products requiring notificationProduct can no longer be legally offered on the market
Both casesConsidered a sanitary infraction, subject to penalties
⚠️ Important nuance ANVISA clarified directlyMissing the notification deadline does not automatically make a product irregular overnight. ANVISA stated explicitly that products already on shelves are not automatically considered irregular the day after the deadline. Labels produced before notification may still be used for up to 180 days from the notification date, solely to exhaust existing packaging stock, provided the product itself becomes properly regularized and its composition or labeling isn’t altered in the meantime.

What this deadline does NOT cover

ANVISA was specific about scope: the expired deadline applies only to the notification requirement introduced by RDC 843/2024’s transition rules. It does not create a new deadline for other standing sanitary requirements under RDC 243/2018, such as stability studies and other technical requirements needed to demonstrate product quality and safety. Those obligations remain in force independent of this notification deadline.

📋 What this means for a brand entering Brazil now

The expired deadline was about legacy products, not new entries

If you’re a US or international brand evaluating Brazil for the first time, this specific expired deadline doesn’t apply to you directly, it covered products already on the market before RDC 843/2024 took effect. What it signals instead: ANVISA is actively enforcing its modernized notification system, and treating deadline compliance seriously. A new product entering Brazil today follows the current RDC 843/2024 notification or registration pathway from day one, without this transition grace period.

Legal deadlines that still apply going forward

Process typeLegal maximum deadline
Class I risk product notification30 days (RDC 336/2020)
Priority-category drug registration120 days (Law 13.411/2016)
Standard-category drug registration365 days (Law 13.411/2016)
Response to a technical requirement (exigência)Minimum 120 days for the company to respond

Beyond the legal deadline (prazo legal), Brazilian regulatory professionals track the practical processing time (prazo comum), which depends on ANVISA’s caseload, staffing, and submission quality, an incomplete notification can add months to the real timeline, well beyond the legal maximum.

From the pharmacy counterWhat I’m watching now, in the days right after this deadline, is how strictly ANVISA enforces it in practice. Agencies sometimes announce a hard deadline and then apply discretion during the immediate transition period. For any brand with a product caught in this notification requirement, the safest move is to treat the deadline as real and act now, not to wait and see whether enforcement is lenient.

Not sure where your product stands with ANVISA?

Whether you’re navigating this expired deadline for an existing product, or planning a new entry into Brazil, get a direct, current read from a licensed pharmacist who tracks these changes in real time.

Read the Full Market Entry Guide →

Frequently Asked Questions

The transition deadline under RDC 843/2024 expired. Supplements operating under the old local notification system had to complete formal ANVISA notification by this date, per RDC 990/2025.
For registration-track products: cancellation of registration. For notification-track products: the product can no longer be legally sold. Both are sanitary infractions subject to penalties.
Not automatically. ANVISA clarified that absence of notification doesn’t make a product automatically irregular. Existing labels can be used up to 180 days from notification, solely to exhaust packaging stock.
In effect since September 1, 2024, it reorganized supplement and food regularization in Brazil, shifting most products to formal ANVISA notification based on a risk-tiered model.
No, the expired deadline applied only to products already on the market before RDC 843/2024. New entries follow the current notification pathway from day one.

References: ANVISA, official notice, “Anvisa alerta e orienta sobre o prazo de adequação às regras de regularização de alimentos,” published September 1, 2026. RDC 843/2024. RDC 990/2025, amending Art. 32 of RDC 843/2024. RDC 983/2025. RDC 336/2020. Law 13.411/2016.


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