What Brazil Law 6360 of 1976 Health Surveillance of Drugs Medicines Cosmetics and Sanitary Products ANVISA Drug Registration Manufacturing Authorisation and RDC Resolutions Framework requires
Brazil Law No. 6.360 of 23 September 1976 establishes the foundational legal framework for health surveillance of drugs medicines cosmetics sanitary products and related items administered by Agência Nacional de Vigilância Sanitária (ANVISA) under the Ministry of Health organised in operative chapters covering Chapter 1 General Provisions Chapter 2 Companies authorisation including authorisation of operation (autorização de funcionamento) and good practices certification Chapter 3 Registration of Products including drug registration (registro de medicamento) with mandatory specifications for safety efficacy and quality Chapter 4 Sale and Distribution Chapter 5 Labelling Chapter 6 Sanitary Inspection and Surveillance Chapter 7 Administrative Procedures and Chapter 8 Penalties including fines product seizure and authorisation revocation. Implementation through ANVISA Resolutions of the Collegiate Board (Resoluções da Diretoria Colegiada RDC) including RDC 753/2022 on Good Manufacturing Practices RDC 658/2022 on drug registration and successor resolutions on clinical trials biosimilars and orphan drugs. Brazil is a full member of ICH and PIC/S harmonising with international pharmaceutical standards while maintaining MERCOSUR pharmaceutical regulatory cooperation.
Pillar: Pharmaceuticals & Life Sciences · Authority: Brazil Ministry of Health and Agência Nacional de Vigilância Sanitária (ANVISA) via Planalto.gov.br · Version: 1.0.0 · Last updated:
Primary source: https://www.planalto.gov.br/ccivil_03/leis/l6360.htm
SHA-256 integrity: 6dabd3cc4d6d95b3983acffffa22c0c549f8826a086d7a657d5ae6c20421e79a
Primary Citations — 8 traced to source
- Brazil Law 6360 of 1976 official text https://www.planalto.gov.br/ccivil_03/leis/l6360.htm
- ANVISA Agência Nacional de Vigilância Sanitária portal https://www.gov.br/anvisa/pt-br
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