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. 

Table of Contents

SANITARY LICENSE
Document Number Document Title Issued by Description Available Languages Download
RDC No. 102/2016 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 102, OF AUGUST 24th, 2016 Anvisa Makes provisions on the procedures for the transfer of registration of products subject to health surveillance, global transfer of responsibility for clinical testing and update of registration data related to the operation and certification of companies as a result of corporate or commercial operations. English/Portuguese For Sale
DECREE No. 8.077/2013 DECREE - 8,077, OF AUGUST 14th, 2013 Anvisa 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, and makes other provisions. English/Portuguese For Sale
LAW No.6.360/1976 LAW No 6,360, OF SEPTEMBER 23rd, 1976 Anvisa Makes provisions on the health surveillance to which medications, drugs, pharmaceutical supplies, healthcare products, cosmetics, sanitizers, and other products are subject, and makes other provisions. English/Portuguese For Sale
INSPECTIONS
Document Number Document Title Issued by Description Available Languages Download
RDC No. 39/2013 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 39, OF AUGUST 14th, 2013 Anvisa Makes provisions on the administrative procedures for granting Good Manufacturing Practice Certification and Good Distribution and/or Storage Practice Certification. English/Portuguese For Sale
ORDINANCE No. 802/1998 ORDINANCE No. 802, OF OCTOBER 8th, 1998 Anvisa Establish the Control and Inspection System in the entire pharmaceutical products chain. English/Portuguese For Sale
IMPORTATION
Document Number Document Title Issued by Description Available Languages Download
RDC No. 81/2008 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 81, OF NOVEMBER 5th, 2008 Anvisa Provides for the Technical Regulation of Imported Goods and Products for Health Surveillance purposes. English/Portuguese For Sale
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