DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 280
Drug Registration Guidance Document (<strong>DRGD</strong>)No.ItemsImmediateLabelOuter LabelPackageInsertBlisterPack19.Additional statement(if applicable)20.Contraindication/ Precaution(if any)21. Security Label (Hologram) #b) All labels and package inserts must be in Bahasa Malaysia or English. Inadditional to this, translation to another language will be allowed.c) # In case of no outer carton, the security label shall be applied to theimmediate labels. The security label shall not be applied onto outer shrinkwrap of a product.d) Please ensure all requirements as specified below are stated on the labelsand package inserts:State the weight per dosage formState the quantity/ content of active ingredients per dosage formFor products in liquid form (syrup), content of active ingredients shall bestated as follows:“Each ____ml (per dosage) product contains extract of the followingingredients”Herb X = ___mgHerb Y = ___mgCheck and correct all spelling/ grammar and translations.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 281
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ATTACHMENT 1Drug Registration Guida
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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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