DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)For product containing Chelidonium Majus, please state (in BahasaMalaysia & English):- Warning: This Product may cause adverse reaction to the liver.- Amaran: Produk ini mungkin boleh menyebabkan kesansampingan pada hepar (hati).For products containing GAMAT/ STICHOPUS spp. for ORAL USE ONLY,please state:“Please consult your pharmacist, doctor, or other healthcare providersabout any other supplements/ medications you are taking and otherhealth care problems. There may be a potential for interactions or sideeffects.”For product contraining Ginkgo biloba/ Ginkgo extract, please state:“As the use of Ginkgo may increase the tendency of bleeding, pleaseconsult your physician/ pharmacist if you are on or intend to startusing any other medicines and before you undergo any surgical/dental procedure.”(Memandangkan Ginkgo boleh meningkatkan kemungkinanpendarahan, sila rujuk kepada doktor/ ahli farmasi sekiranya andasedang atau sedang akan menggunakan ubat lain dan sebelumprosedur pembedahan/ dental dijalankan.)For products containing GINSENG (including all PANAX genus), please state:- “Contraindicated in pregnant women.”- “Safe use in lactating women and children has not beenestablished.”- “Do not exceed the stated dose.”- “Safety on long term use has not been established.”National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 280
Drug Registration Guidance Document (<strong>DRGD</strong>)For product containing Momordica Charantia, please state:- “Shall not be used in pregnant and breast-feeding women.”- “Be sure to tell your pharmacist, doctor, or other healthcareproviders about any other supplements you are taking. There maybe a potential for interactions or side effects.”For product containing Pelargonium sidoides, please state:In very rare cases, pelargonium sidoides may causehypersensitivity reactionsFor product containing Propolis (topical preparation), please state:“Propolis may cause allergic skin reaction.”For product containing Propolis (for oral use), please state:- “This product contains propolis and may cause severe allergicreactions including fatal anaphylactic reaction in susceptibleindividuals.”- “Asthma and allergy sufferers may be at a greater risk.”For product containing Royal Jelly (for oral use), please state:- “This product contains royal jelly and may cause severe allergicreactions including fatal anaphylactic reaction in susceptibleindividuals.”- “Asthma and allergy sufferers may be at a greater risk.”For product containing naturally occurring SALICYLIC ACID (e.g. WillowSalix spp.), please state:- “People allergic to aspirin/ other NSAID should avoid thisproduct.”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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ATTACHMENT 2Drug Registration Guida
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Page 230 and 231: APPENDIX 5:Drug Registration Guidan
Page 232 and 233: 1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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