DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)SECTION C: PARTICULARS OF PACKINGPackaging‣ Maximum pack size allowed for tablets, pills, capsules is based on dailydosing for a quantity not exceeding six (6) months usage.‣ Maximum pack size allowed with disease risk reduction claim for 1 monthsupply of products unless justified.‣ Product with dosage form of softgel with tail (twist and squeeze) shall comewith children proof cap.Packing particulars to the listing of packing as follows ;- C1: pack size and fill details by weight, or volume or quantity;- C2 : container type- C3 : Barcode/ serial No (optional);- C4 : recommended distributor‟s price (optional);- C5 : recommended retail price (optional);National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 206
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 | 207
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Page 230 and 231: PART III: NON-CLINICAL DATADrug Reg
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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