DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 286
Drug Registration Guidance Document (<strong>DRGD</strong>)2.7.2 SPECIFIC LABELLING STATEMENTS/ WARNING &PRECAUTIONSFor products containing the following active ingredients, specific cautionarystatement(s) as specified shall be included:For product containing Alfalfa (Medicago sativa), please state:This product contains Alfalfa (Medicago sativa).Individuals with a predisposition to systemic lupus erythematosus shallconsult their physician before consuming this product.For product containing „Anti-diarrhoea‟, please state:“Contraindicated in children below 1 year old.”For product containing Aspartame, please state:WARNING:“Unsuitable for phenylketonurics”For products containing BEE POLLEN, please state:- This product contains Bee Pollen and may cause severe allergicreactions, including fatal anaphylactic reactions in susceptible individuals.- Asthma and allergy sufferers may be at greater risks.For product containing Benzyl Alcohol/ Phenylmethanol (as preservative),please state:As this preparation contains benzyl alcohol, its use shall beavoided in children under 2 years of age. Not to be used inneonates.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 287
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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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