DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)TestsAcceptance Criteria/SpecificationFrequency of Test, in month (Kekerapan Ujian, bulan)0 3 6 9 12 15 18 21 24Heavy Metal Test:- Lead- Arsenic- Mercury- Cadmium≤10.0 mg/kg (≤ 10ppm)≤5.0 mg/kg (≤ 5ppm)≤0.5 mg/kg (≤ 0.5ppm)≤0.3 mg/kg (≤ 0.3ppm)Conclusion ------------------------------------------------------------Prepared by: (signature) Checked by: (signature)Name:Name:Designation:Designation:Date:Date:Approved by:Name:Designation:Date:(signature)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 278
Drug Registration Guidance Document (<strong>DRGD</strong>)2.7 LABELLING REQUIREMENTa) The following information as shown in Table 9 shall be included in the productlabel. Please refer example of label for natural products approved by theAuthority, as shown below.No.ItemsImmediateLabelOuter LabelPackageInsertBlisterPack1. Product name2. Dosage Form √ √ √ √3.4.Name of active ingredients,including part of plant usedStrength of active ingredientin weight5. Indication6. Batch number7. Manufacturing date8. Expiry date9. Dosage/ Use instruction10.Storage condition(s)- state temperature used inthe stability study- state “Protect from lightand moisture” (If productis not packed in moistureresistant container)11. Registration number (MAL)12.Name and address ofproduct registration holder(Example: ProductRegistration Holder: XXXXX)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 279
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ATTACHMENT 1Drug Registration Guida
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Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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