DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)9.1 GENERAL LABELLING REQUIREMENTS9.1.1 LABEL (MOCK-UP) FOR IMMEDIATE CONTAINER AND OUTER CARTONThe following information in Table 1 shall present on the label of a product at outercarton, immediate container or blister/ strips: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 * NA14. Pack Sizes (unit/ volume) NA15.Name & content ofpreservative(s) where present NANational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 344
Drug Registration Guidance Document (<strong>DRGD</strong>)No. ParametersOuter Carton(Unit Carton)ImmediateLabelsBlister/Strips16.17.18.19.20.21.Name & 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)The words “ControlledMedicine/ Ubat Terkawal”(For scheduled poison only) NA NA NA * NA * NA * NA22. Security Label (Hologram) # * NANA : Not Applicable* Exempted for small labels such as used in ampoules/ cartridge and vials.** For multi-vitamins and minerals preparations it is suggested to label as multivitaminsand minerals.# 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 aproduct.No. 15, 19, 21 & 22 of the above are country specific requirements for Malaysia.Additional Information:a) If the product is without an outer carton, the inner label shall bear all theinformation that is required.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 345
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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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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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