Brazil's Anvisa Regulations
Brazil’s Health Authority known as, Agência Nacional de Vigilância Sanitária, or Anvisa, is the regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices.
SANITARY LICENSE
Document Title | Description | Issued by | Available Languages | Download |
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RDC No. 102/2016: Procedures for the Transfer of Registration of Products and Clinical Testing subject to Health Surveillance notification. | This Resolution also covers the cases of operations performed abroad that require update under ANVISA.which result in the need to update the registration data related to the operation and certification of companies, global transfer of responsibility for clinical testing and transfer of registration of products subject to health surveillance updates. | Anvisa | English | For Sale |
DECREE 8,077/2013: Registration, Control, and Monitoring of the products and the conditions for the operation of companies subject to Sanitary Licensing, within the scope of Health Surveillance. | This Decree hereby regulates the registration, control, and monitoring of the products addressed by Law 6,360, of September 23rd, 1976, and the conditions for the operation of companies subject to sanitary licensing, within the scope of health surveillance. | Anvisa | English | For Sale |
INSPECTIONS
Document Title | Description | Issued by | Available Languages | Download |
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Normative Instruction No. 32/2019: Inspection Processes and Requirements to verify the Good Manufacturing Practices of manufacturers of Active Pharmaceutical Ingredients, Health Products of risk class III and IV and Medicines. | This Normative Instruction establishes the procedures, flows, instruments and schedule related to compliance Inspection Processes and Requirements to verify the Good Manufacturing Practices of manufacturers of active pharmaceutical ingredients, Health Products of risk class III and IV and Medicines. | Anvisa | English | For Sale |
IMPORTATION
Document Title | Description | Issued by | Available Languages | Download |
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RDC No. 81/2008: Technical Regulation of Imported Goods and Products for Health Surveillance. | Approve the Technical Regulation of Imported Goods and Products for the purposes of Health Surveillance, according to the Chapters of this Resolution. | Anvisa | English | For Sale |