DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCE2.4 Product NameItem No. 11:Issue: Addition of „or referring to the profession‟.Example: Addition of „Herbalist, Doctor‟.7.March2013Appendix 5,Guideline onRegistration ofNaturalProducts*For Ginseng:Appendix 4,Appendix 5 andAppendix 9Addition of new item which is numbered as No. 13:Issue:Prohibited use of product names referring to any religiouscontentExample: Maksum, Mahmudah, Arifbillah2.7 Labelling Requirementd) Example of label approved by the AuthorityReplacement with a new example.2.7.2 Specific Labelling Statements/ Warning & Precautionsa) Amendment from:For products containing GINSENG (including all Panaxgenus), please state:- “Safe use of ginseng in pregnant women and childrenhas not been established.”- “Do not exceed the stated dose.”“Safety on long term use has not been established.”Memo from Sub-Section ofComplementary Medicine(24)dlm.BPFK/PPP/06/17Jilid 31, 29 March 2013To:National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 490
Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEFor products containing GINSENG (including all PANAXgenus), 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.”b) Addition of the following:For product containing naturally occurring SALICYLICACID (e.g. Willow Salix spp.), please state:“People allergic to aspirin/ other NSAID should avoid thisproduct.”For products containing GAMAT/ STICHOPUS spp. forORAL USE ONLY, please state:“Please consult your pharmacist, doctor, or other healthcareproviders about any other supplements/ medications you aretaking and other health care problems. There may be apotential for interactions or side effects.”2.7.4 Prohibited Visual/ Graphics/ Statement On Label OfNatural Productsa) Amendment of the title 2.7.4 to the following:“Prohibited Visual/ Graphics/ Statement on PackagingNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 491
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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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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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