How To Deal With Changes In Product Registration With ANVISA?

Any changes to already registered products (such as formula modifications, labeling updates, new therapeutic indications, or adjustments to expiration dates) require prior approval from ANVISA. This even includes technical updates, such as the inclusion of accessories or changes to storage conditions.

The risk of ignoring this step?

• Product ban: Marketing without authorization results in heavy fines;
• Forced recall: Unreported changes can compromise user safety, leading to emergency recalls;
• Blocking innovation: Without approval, companies miss opportunities to optimize portfolios.

Strategic tip: Aesthetic updates (such as label formatting) do not require a formal request, as long as they do not affect safety or efficacy.

I WANT TO CHANGE MY REGISTRATION SAFELY

ANVISA requires specific documents for each type of change, listed in public checklists (available by “Subject Code” in the Petitioning System). Common errors that stall processes:

•  Incomplete forms: Petitions with blank fields or missing information are summarily rejected;
• Lack of technical evidence: Changes in formulas require stability studies or analytical reports;
• Failure to meet deadlines: After notification of failures, you have only 30 days to correct them.

Practical solution: For food products, IN No. 281/2024 details mandatory attachments. For biological products, RDC 876/2024 reduced requirements for minor changes.

I WANT TO AVOID MY REQUEST BEING REJECTED

With new rules in place, companies can cut deadlines in half:

1. a) Smart grouping of changes
   RDC 913/2024 allows multiple changes to be filed in a single request if they are interrelated—such as labeling adjustments + validity extensions. Previously, each change required a separate process.
2. b) Conditional approval via international harmonization
   Under IN 289/2024, ANVISA accepts assessments from foreign agencies (such as the FDA or EMA) to validate technical changes, speeding up reviews by up to 60%%.
3. c) Full digitization
   Systems such as Solicita are mandatory for filing. Companies that have migrated to the electronic format have reduced errors by 40%.

ANVISA is modernizing processes with a focus on:

• Consolidation of standards: Merging of three resolutions (RDC 73/16, RDC 708/22, and RDC 413/20) into a single framework, simplifying requirements for drugs and biologicals;
• New risk classification: Changes to “low complexity” products (such as probiotics) will have more streamlined procedures;
• e-CTD (Common Technical Document): A globally standardized digital format will be mandatory for dossiers, improving traceability.

In 2025, dealing with post-registration changes at ANVISA is no longer a “necessary evil” but a strategic advantage. Companies that master this process:

1. Adapt quickly to market trends;
2. Avoid hidden costs from fines, recalls, or shutdowns;
3. Gain the trust of distributors and consumers.

With Stone Okamont, you can turn regulatory requirements into growth opportunities. Request an assessment and find out how to accelerate your changes with legal certainty.