DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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) 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 | 284
d) Example of label approved by the Authority:Drug Registration Guidance Document (<strong>DRGD</strong>)This is a traditional medicinePlease consult your pharmacist/doctor before taking this productJauhkan daripada kanak-kanakKeep out of reach of childrenIndication: Traditionally used forwomen‟s healthWarning: Pregnancy andbreastfeeding: Insufficient reliabledataKeep below 30 ° celciusProtect from light and moistureManufacturing date:Expiry date:Batch No.:KAPSUL PQR500MGMALXXXXXXXXT50 CAPSULEHologramEach Capsule (Vegetable capsule)contains :Folium XXFructus QY200mg300mgDosage : 2 capsule taken twice aday after foodMarketing authorization holder:Syarikat XYZ Sdn Bhd18, Jalan Utama47000 Sungai BulohSelangorManufactured by:Syarikat ABC Sdn Bhd3, Jalan Universiti46730 Petaling JayaSelangorManufacturing date :Expiry date:Batch No. :2.7.1 STATEMENTS TO BE STATED ON PRODUCT LABELThe following statements shall also be stated on the product label, whereapplicable:For product with an indication “For general health/ well being” or“Untuk kesihatan umum”, please state:- “Please consult your pharmacist / doctor before taking this product orSila merujuk kepada ahli farmasi/ doktor sebelum mengambilproduk ini.”For product with an indication “To relieve symptoms for…. (anyillness)” or “untuk mengurangkan tanda-tanda/ simptom….”, pleasestate:- “Please consult your pharmacist/ doctor if symptoms persist/ worsenor Sila merujuk kepada ahli farmasi/ doktor jika simptom berlarutan/bertambah teruk.”National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 285
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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