DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)SECTION D: LABELLING REQUIREMENTSLabel (mock-up) for immediate container, outer cartonOuter Unit Carton, Immediate & Blister/ Strips LabelsThe following information in Table 13 shall be present on the label of theproduct:No. ParametersOuter Carton(Unit Carton)ImmediateLabelsBlister/Strips1. Product Name 2. Dosage Form * NA3. Name of Active Substance(s) **4. Strength of Active Substance(s) **5. Batch Number 6. Manufacturing Date * NA7. Expiry Date 8. Route of Administration NA9. Storage Condition * NA10. Country‟s Registration Number * NA11.12.13.Name & Address of ProductRegistration Holder (PRH)Name & Address ofManufacturerWarnings and/or SpecificLabelling(if applicable) *At least nameof town/ cityand country ofmanufacturer*At least nameof town/ cityand countryofmanufacturerName/ LogoofManufacturer/ProductOwnerNA * NANational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 204
Drug Registration Guidance Document (<strong>DRGD</strong>)No. ParametersOuter Carton(Unit Carton)ImmediateLabelsBlister/Strips14. Pack Sizes (unit/ volume) NA15.16.17.18.19.20.Name & content ofpreservative(s) where presentName & content of alcohol,where presentTo declare source ofingredients derived from animalorigin, including gelatin (active,excipient, and/or capsule shell)Recommended daily allowance(RDA) for vitamins/multivitamins/ mineralpreparations used as dietarysupplementsThe words “Keep medicine outof reach of children” or wordsbearing similar meaning in bothBahasa Malaysia & EnglishOther country specific labellingrequirements(if applicable) NA NA NA NA * NA * NA21. Security Label (Hologram) # * NANotes:NA - Not applicable** For multi-vitamins and minerals preparations it is suggested to label as multivitaminsand mineralsIf the product is without an outer carton, the inner label shall bear all the informationthat is requiredInformation on the Product Name and Name and Strength of active ingredient(s)must be printed repeatedly.# In case of no outer carton, the security label shall be applied to the immediatelabels. The security label shall not be applied onto outer shrink wrap of a product.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 205
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Page 154 and 155: Drug Registration Guidance Document
Page 202 and 203: Appearance/organoleptic(odor, color
Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 230 and 231: ATTACHMENT 2Drug Registration Guida
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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