DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)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 | 494
Drug Registration Guidance Document (<strong>DRGD</strong>)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEMaterial (Label, Box, Package Insert or Patient InformationLeaflet)”b) Addition of the following paragraph under this title 2.7.4:"General requirement: The graphics printed on outer and innerlabel has to be standardized to avoid confusion to thecustomers."1. April 2013Section E:Post-RegistrationProcessReplacement with the latest information at 16.3 Change ofProduct Registration HolderDrug Control AuthorityMeeting No. 263, 29 April2013National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 495
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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