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  • April 20, 2022
  • WTO

Brazilian Health Surveillance Agency released Draft Technical Resolution nº 18, 10 March 2015, Regarding Post-Registration Changes and Cancellation of Drugs Registration

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This Draft Technical Resolution aims to classify post-approval changes in drugs, to establish the criteria and the minimum required documentation necessary to that, to provide direct responsibilities of companies and to establish the simplified procedure of post-approval changes for immediate implementation, in order to ensure quality, safety and efficacy of drugs. 
This Resolution revokes Resolution RDC No.48/2009 and Normative Instruction Nº11/2009. 

Relevant document:

 WTO Notification G/TBT/N/BRA/629

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