ANVISA published Instrução Normativa (IN) nº 404/2025, updating Brazil’s national list of Non-Prescription Medicines (Medicamentos Isentos de Prescrição – MIP). The update amends Annex I of IN 285/2024, which establishes the regulatory criteria for over-the-counter (OTC) medicinal product classification in Brazil.
The revised list incorporates new pharmaceutical forms and strengths into the MIP framework, allowing certain medicinal products to be marketed without prescription while maintaining pharmacist oversight and risk-based conditions for use. These changes reflect ANVISA’s ongoing efforts to align OTC classifications with current scientific evidence, international regulatory practices, and public health considerations.
Key Highlights
- Update of the National MIP / OTC List
IN 404/2025 updates Brazil’s official list of non-prescription medicines under the national regulatory framework. - Amendment to IN 285/2024
Revises Annex I to include new medicinal products, pharmaceutical forms, and strengths eligible for OTC classification. - Rx-to-OTC Reclassification Pathways
Supports prescription-to-OTC (Rx-to-OTC) switches aligned with scientific evidence and international best practices. - Consumer Health Market Impact
Creates regulatory opportunities for portfolio expansion, OTC lifecycle strategies, and enhanced market access in the consumer health segment. - Regulatory Modernization
Reinforces ANVISA’s initiatives to modernize OTC regulations while maintaining appropriate risk management and pharmacist involvement.
This regulatory update strengthens Brazil’s OTC framework and provides a clearer pathway for companies evaluating reclassification strategies and consumer health market expansion.
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