In Brazil’s pharmaceutical landscape, the most critical regulation governing the lifecycle of medicinal products is Law No. 6,360/1976. Enforced by Anvisa (Agência Nacional de Vigilância Sanitária), this law, ANVISA´s Resolutions of the collegiate board, normative instructions and guidesestablishes the legal and operational framework for the sanitary control of medicines, drugs, pharmaceutical inputs, and related products across their entire lifecycle—from development and registration to commercialization and post-market surveillance.

Regulating Medicines in Brazil: Why Law 6,360/1976 Still Sets the Standard?

Enacted in 1976, Law No. 6,360 lays the foundation for Brazil’s health Regulatory system. It defines the requirements for manufacturing, importing, marketing, labeling, packaging, advertising, and registration of medicinal products and their subsequent renewal.

This law ensures that all medicinal products distributed in the Brazilian market meet predefined safety, efficacy, and quality standards, and that these standards are consistently upheld throughout the product’s lifecycle.

Scope and Regulatory Coverage

The law applies to a wide range of products, including:

• Medicines and drugs for human use
• Pharmaceutical raw materials and inputs
• Diagnostic and therapeutic medical products
• Cosmetics, sanitizers, and personal hygiene items (where applicable)
• Medical Device and other health related products

It also governs procedures for:

• Authorization of Companies and Licensing of Establishments
• Marketing authorization and post-market changes
• Technical Responsibility
• Product labeling and packaging standards
• Advertising
• Transportation of health products
• Import and export authorizations
• Infractions, Penalties and Monitoring
• Quality Control of Medicines

Anvisa’s Role in Enforcement

While Law No. 6,360/1976 serves as the legislative backbone, Anvisa—established by Law No. 9,782/1999—is the federal Regulatory authority tasked with enforcing and interpreting the law. Anvisa does this through the issuance of RDCs (Resoluções da Diretoria Colegiada), which translate the law into specific Regulatory requirements.

Key RDCs that support the implementation of Law No. 6,360/1976 include:

• RDC 55/2010 - Provides for the registration of new biological products and biological products.
• RDC 913/2024 - Provides for post-registration changes and cancellation of registration of biological products.
• RDC 753/2022 - Registration of medicines for human use with synthetic and semi-synthetic active ingredients, classified as new, innovative, generic and similar.
• RDC 882/2024 - Criteria and procedures for classifying medicines as non-prescription and reclassifying them as prescription medicines.
• RDC N°. 948/2024 - Provides for the health requirements for the regulation of medicines for human use.
• RDC No. 73/2016 – Provides for post-registration changes, cancellation of registration of medicines with synthetic and semi-synthetic active ingredients and other provisions.
• RDC 96/2008: Provides for advertising, publicity, information and other practices whose objective is the dissemination or commercial promotion of medicines.
• RDC No. 204/2017 – Details procedures for prioritizing the review of registration and post-registration submissions
• RDC 81/2008 - Provides for the Technical Regulation of Imported Goods and Products for Health Surveillance

Why Is Law No. 6,360/1976 So Important?

Understanding and complying with Law No. 6,360/1976 is essential for any pharmaceutical company seeking to commercialize products in Brazil. It is the legislative foundation for:

• Securing marketing authorizations from Anvisa
• Structuring compliant product development and registration strategies
• Navigating post-approval variations and renewals
• Maintaining long-term Regulatory compliance within Brazil’s complex but high-potential pharmaceutical market.

What Should Pharmaceutical Companies Know?

Pharmaceutical manufacturers and Regulatory affairs professionals should:

• Familiarize themselves with Law No. 6,360/1976 and associated RDCs, normative instructions and Guidelines
• Develop a strategy aligned with Anvisa’s current dossier expectations and CTD structure
• Establish internal SOPs that reflect the law’s requirements and operationalize local compliance
• Monitor Anvisa’s Regulatory agenda for upcoming changes and consultations
• Collaborate with local experts or Regulatory service providers to navigate submissions, renewals, and inspections

Conclusion

Law No. 6,360/1976 is the foundation of medicinal product regulation in Brazil, covering everything from market authorization to post-market compliance. Enforced by Anvisa and supported by RDCs, normative instructions and guidelines it ensures alignment with both local priorities and global standards.

Our Regulatory experts provide complete support—from strategy and dossier preparation to GMP, pharmacovigilance, and lifecycle management—ensuring smooth, compliant market access.

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