DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 282
Drug Registration Guidance Document (<strong>DRGD</strong>)No.ItemsImmediateLabelOuter LabelPackageInsertBlisterPack13.Name and address ofmanufacturer(Example: Manufacturer:XXXXX)At least nameof town/ cityand countryofmanufacturerAt least nameof town/ cityand countryofmanufacturer14.Warning label (if applicable)a. Ginsengb. Bee pollenc. Senna leaf (Cassia) andRhubarb/ radix orRhizoma Rheid. Camphore. Chelidonium majusf. Alfalfa (Medicago sativa)g. St. John‟s Worth. Black cohoshi. Propolisj. Royal jellyk. Ginkgo biloba / Ginkgoextractl. Pelargonium sidoidesm. Benzyl Alcohol /Phenylmethanol(preservative)n. Red Yeast Riceo. Substance from seafood15. Pack size (unit/ volume)16.17.Name and strength ofpreservativeName and content ofalcohol,where present18.To declare source ofingredients (active, excipient,and / or capsule shell) -derived from animal originNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 283
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PART III: NON-CLINICAL DATADrug Reg
Page 232 and 233: - All information must be provided
Page 234 and 235: Drug Registration Guidance Document
Page 242 and 243: 1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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