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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/6292013 © MyChemicalMonitoring. ALL Rights Reserved. About Us | Terms and Conditions
