DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)As the use of Ginkgo may increase the tendency of bleeding, please consultyour physician/ pharmacist if you are on or intend to start using any othermedicines and before you undergo any surgical/ dental procedure.(Memandangkan Ginkgo boleh meningkatkan kemungkinan pendarahan, silarujuk kepada doktor/ ahli farmasi sekiranya anda sedang atau/ akanmenggunakan ubat lain dan sebelum prosedur pembedahan/ dentaldijalankan).7. GINSENGThe following statements shall be included on the labels and in the packageinsert of products containing Ginseng (including all Panax genus):Contraindicated in pregnant women.Safe use in lactating women and children has not been established.Do not exceed the stated dose.Safety on long term use has not been established.8. INGREDIENTS DERIVED FROM SEAFOODThe following statement shall be included on the labels and in the packageinsert of products.“DERIVED FROM SEAFOOD”9. ROYAL JELLYThis product contains royal jelly and may cause severe allergic reactionsincluding fatal anaphylactic reactions in susceptible individuals.Asthma and allergy sufferers may be at the greater risk.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 204
Drug Registration Guidance Document (<strong>DRGD</strong>)10. SODIUM METABISULPHITE (Excipient)The following statement shall be included in the package insert of productscontaining Sodium metabisulphite:WARNING:This preparation contains Sodium metabisulphite that may cause seriousallergic type reactions in certain susceptible patients. Do not use if known tobe hypersensitive to bisulphites.Prohibited Visual/ Graphics on Label, as shown in Table 14 below:No. Issue Example Note1.Marketing strategyExample:“Money back guarantee”“Buy 1 free 1”“Backed by RM5 millionproduct Liability Insurance”Such statementsare prohibited onlabels, as perMedicines(Advertisementand Sale) Act1956 requirements2.Usage guide whichpromotes use ofother product(s)Example:“After consumption of thisproduct (Product A), forbetter results, it isrecommended to takeProduct B”Prohibited onproduct label3. Consumer testimonialProhibited onproduct labelNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 205
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Page 154 and 155: Drug Registration Guidance Document
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Page 222 and 223: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 232 and 233: 1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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