DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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e) 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 | 282
Drug Registration Guidance Document (<strong>DRGD</strong>)“This is a traditional medicine/Ini adalah ubat tradisional.” OR “This is ahomeopathy medicine/Ini adalah ubat homeopati.”Unless otherwise supported, all herbal/ traditional products label shallstate the following general cautionary statement, EXCEPT for productwith indication for men‟s health or product for children use only:“Pregnancy and breastfeeding: Insufficient reliable data”For product with an indication to be taken/ used specially for women,please refer 2.6.3 Cautionary Statement for Products SpeciallyUsed in Women.“Keep out of reach of children & Jauhi dari kanak-kanak” (in bothBahasa Malaysia and English).“Protect from light and moisture.”Please state the storage condition according to the temperature statedin stability data.For products containing ingredients as specified below, please add therequired statements:i) Animal part(s):“This product contains animal part(s).”ii) Animal origin(s):“This product contains substance(s) from animal origin.”iii) Porcine:“This product contains animal part(s) (porcine/ pig).”iv) Alcohol:- “This product contains alcohol.”- Please declare the percentage of alcohol contained in theproduct.For the following dosage forms, please add this statement:i) Topical preparations: “For external use only.”ii) Liquids and suspensions: “Shake well before use”National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 283
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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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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