DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)APPENDICESAppendix 1Appendix 2Appendix 3Appendix 4Appendix 5Appendix 6Appendix 7Appendix 8Appendix 9Appendix 10Appendix 11Appendix 12Appendix 13FeesRequirements for Product RegistrationGuidelines on Registration of BiologicsGuideline on Registration of Health SupplementsGuideline on Registration of Natural ProductsGuideline on Regulatory Control of Active PharmaceuticalIngredients (API)Special Conditions for Registration for a Particular Product orGroup of ProductsList of Permitted, Prohibited and Restricted SubstancesLabelling RequirementsGuideline on Patient Dispensing Pack for PharmaceuticalProducts in MalaysiaGuideline on Filling the Online Application Form for ProductRegistration via Quest SystemConditions and Supporting Documents Required forApplication of Variation Type I & Type IISupporting Documents Required for Change of ManufacturingSite (COS) ApplicationNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 126
Drug Registration Guidance Document (<strong>DRGD</strong>)APPENDIX 1:FEESOutline:1.1 Charges for USB Token of QUEST Membership;1.2 Processing and Analysis Fee for Product Registration;1.3 Charges for Application of Licence;1.4 Charges for Amendments to Particulars of a Registered Product; and1.5 Fee for Certificates.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 127
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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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