DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEMaterial (Label, Box, Package Insert or Patient InformationLeaflet)”b) Addition of the following paragraph under this title 2.7.4:"General requirement: The graphics printed on outer and innerlabel has to be standardized to avoid confusion to thecustomers."National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 486
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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