DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCE17.2.1 PRODUCT COMPLAINTSa) The product registration holder should notify the NPCBDirector of Pharmaceutical Services of any product qualityrelated problems (with registered products) that the holder isaware of;b) It is also the responsibility of the prescribers, thepharmacists, as well as all other health professionals whocome into contact with the drug to report to NPCB by usingthe NPCB complaint form i.e. BPFK 419 / BPFK 418.4together with complaint sample (if any).c) All complaints received will be investigated by the NPCB aswell as product registration holder/ manufacturer. It is theresponsibility of the company to determine the appropriatecorrective and preventive action.Guidelines on Good Distribution Practice, Chapter 9.17.2.2 PRODUCT RECALLSa) The decision for recalls of defective or unsafe a productsshall be made when there is or may cause potential risk tothe user of the products. Recalls may be done voluntarily bythe product registration holder or as directed are institutedby the Authority, supported by the Director ofPharmaceutical Services Division, Ministry of HealthMalaysia;National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 496
Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEb) The product registration holder is responsible for conductingrecalls of defective or unsafe products. No recall should takeplace without first consulting/ informing the Authority.Director of Pharmaceutical Services.Guidelines on Good Distribution Practice, Chapter 10.Replacement of this statement at 4.1.4 Exclusion as HealthSupplement:6. May 2013Appendix 4:Guideline onRegistration ofHealthSupplement“(iii) Any human part or substance derived from any part of thehuman body;” (deleted)With the following:Pharmacy RegulatoryPolicy MeetingNo. 1/2013“iii) Any cells, tissues, organs or any substance derived fromthe human body;” (replacement)7. May 2013Appendix 4:Guideline onRegistration ofHealthSupplements;Appendix 5:Guideline onRegistration ofNaturalAddition of the following paragraph as “#” at column OuterCarton for Security Label (Hologram):“In case of no outer carton, the security label shall be applied tothe immediate labels. The security label shall not be appliedonto outer shrink wrap of a product.”NPCB Dialogue with MOPI,PhAMA and MAPS onDRGD& Pharmacy RegulatoryPolicy Meeting No. 1/2013National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 497
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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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