DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NMTNPCBNRVOTCPh. Eur.PIPIC/SPILPMFPOAppmPRHPSURPVRNARSDSIRIMSPCspp.Syn.Not More ThanNational Pharmaceutical Control BureauNutrient Reference ValueOver-the-CounterEuropean PharmacopoeiaPackage InsertPharmaceutical Inspection Co-operation SchemePatient Information LeafletPlasma Master FileProtocol of Analysisparts per millionProduct Registration Holder(Previously known as Marketing Authorization Holder, MAH)Periodic Safety Update ReportProcess ValidationRibonucleic acidRelative Standard DeviationStandards and Industrial Research Institute of MalaysiaSummary of Product CharacteristicsSpeciesSynonymNational Pharmaceutical Control BureauFirst Edition, January 201310
Drug Registration Guidance Document (<strong>DRGD</strong>)TAMCTGATLCTSETYMCUSPUSPIUVVVMWCBWHOTotal Aerobic Microbial CountTherapeutic Goods AdministrationThin Layer ChromatographyTransmissible Spongiform EncephlopathiesTotal Yeasts and Moulds CountUnited State PharmacopeiaUS Package InsertUltra-VioletVaccine Vial MonitorWorking Cell BankWorld Health OrganisationNational Pharmaceutical Control BureauFirst Edition, January 201311
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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