DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)145. ZOLPIDEM TARTRATEPlease refer to SEDATIVE – HYPNOTIC PRODUCTS146. ZOPICLONEPlease refer to SEDATIVE – HYPNOTIC PRODUCTSNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 422
Drug Registration Guidance Document (<strong>DRGD</strong>)APPENDIX 10GUIDELINE ON PATIENT DISPENSING PACK FORPHARMACEUTICAL PRODUCTS IN MALAYSIAOutline:10.1 Purpose10.2 Objective10.3 Definition10.4 Benefits10.5 Criteria for Implementation of Patient Dispensing Pack10.6 Products Exempted from this Requirements10.7 Other Considerations for Implementation10.8 Implementation Timeline10.9 ConclusionNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 423
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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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