Client Overview
A German multinational pharmaceutical and life sciences company with a global footprint sought to expand market access for a topical product in Brazil by switching its classification from prescription (Rx) to Over-the-Counter (OTC). The engagement required specialized knowledge of ANVISA's regulatory framework — specifically RDC 98/2016 and Normative Instruction No. 11/2016 — and a structured approach to justify the reclassification against Brazil's official non-prescription drug list (LMIP).
Background
The client had already secured OTC approval for this product in several regulated international markets. In Brazil, however, prior approvals carry limited weight on their own. ANVISA requires a standalone safety and regulatory justification built to local standards — one that accounts for Brazil's specific classification criteria, labeling requirements, and post-market surveillance expectations.
The client needed a regulatory partner with both ANVISA expertise and the ability to translate global safety data into a locally compliant submission package. Speed mattered: delays in dossier preparation or post-submission queries could push the market access window significantly.
Services in Scope
Gap analysis of global safety data vs. ANVISA classification requirements
Strategic framing of the switch justification aligned with RDC 98/2016
Compilation and review of the full OTC switch dossier
Labeling compliance review against therapeutic class indications
Documentation gap mitigation strategy
Formal submission to ANVISA
Post-submission query management and resolution
Challenge
Brazil's OTC switch process is not a simple reclassification exercise. ANVISA evaluates each request against a stringent set of criteria: the product must appear on the LMIP, the safety profile must be substantiated for unsupervised consumer use, and all labeling must reflect the appropriate therapeutic class under the new classification.
For this client, three compounding challenges defined the engagement:
Establishing a locally credible safety profile, despite the absence of prior Brazilian market data, required careful construction of the evidence dossier using data from other regulated markets.
Labeling compliance added complexity — the reclassification required full realignment of label content with ANVISA's OTC classification criteria, including indication language, warnings, and consumer-facing instructions.
Documentation gaps in the dossier posed a risk to submission timelines. A structured mitigation approach was needed to prevent these from triggering avoidable delays or regulatory objections.
Solution
1
Freyr conducted a comprehensive evaluation of global safety data, identifying which evidence could be effectively leveraged under ANVISA's classification framework and what gaps needed to be addressed before submission.
2
The team built a structured dossier with a targeted mitigation strategy for documentation gaps — prioritizing completeness and regulatory coherence over volume.
3
Labeling was reviewed and adapted to ensure full alignment with ANVISA's therapeutic class indications for OTC products, minimizing risk of post-submission labeling objections.
4
Safety data from international markets where the OTC switch had already been approved was strategically incorporated to reinforce the justification for reclassification in Brazil.
5
Following formal submission, Freyr's team managed post-submission queries and provided timely resolutions to keep the regulatory process on track.
Impact
Freyr's regulatory expertise enabled the client to move from a complex, multi-market evidence base to a fully compliant ANVISA submission without delays or critical objections. The outcome demonstrated that international OTC approvals can be effectively translated into Brazil's regulatory framework — provided the local logic is understood from the start.
Efficient pre-assessment of the full Regulatory submission pathway
Timely dossier development, compilation, and submission to ANVISA
Effective post-submission query resolution
Seamless alignment with LMIP (non-prescription drug list)
Global safety data successfully leveraged to support the switch justification
Successful OTC switch application submitted in full compliance with RDC 98/2016
