DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Package inserts (Optional)The following information is required to be included in a package insert:(i)(ii)(iii)(iv)(v)(vi)(vii)(viii)(ix)(x)(xi)(xii)(xiii)(xiv)(xv)Brand or Product NameName and Strength of Active Substance(s)Product DescriptionIndicationDose/ Use InstructionContraindicationsWarnings and PrecautionsInteractions with Other MedicationsStatement on usage during pregnancy and lactationAdverse Effects/ Undesirable EffectsOverdose and TreatmentStorage Conditions (may be omitted if the information is stated on thelabel or outer carton labels)Dosage Forms and packaging availableName and Address of manufacturer/ product registration holderDate of Revision of Package InsertNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 206
Drug Registration Guidance Document (<strong>DRGD</strong>)Standard Labelling for Health SupplementsName and Strength ofactive substances, RDAPreservative(s) (wherepresent)Alcohol (where present)IndicationDose / Use InstructionFunctional ClaimWarnings (If applicable)Name & address ofMarketingAuthorization HolderName & address ofManufacturerName & address ofRepacker (ifapplicable)Sources (animalorigin)Storage ConditionKeep out of reachof children / Jauhi darikanak-kanakPack SizeDosage FormBatch NumberManufacturing DateExpiry DateMAL ……………………...Note:Product label shall follow the standard labelling for Health SupplementInformation stated in the left and right panel is interchangeable.All information on the label must be truthful and not misleading to the consumers.Batch number, manufacturing date, expiration date: can be stated on label, on top of cap orbottom of bottleNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 207
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Page 156 and 157: Drug Registration Guidance Document
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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