DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)17.3 PUNITIVE ACTION FROM THE AUTHORITY17.3.1 ADULTERATIONAs stated in circular Bil (30) BPFK/PPP/01/03, 13 th May 2009, punitive action shall be takenagainst companies who are involved in adulteration.Any registered products found to have been adulterated, the following action shall be takenby the Director of Pharmaceutical Services:a) The registration of the related product shall be cancelled and recall of all batches ofthe product shall be done immediately;b) The manufacturer‟s license of the related manufacturer shall be revoked for six (6)months for the first offence and one (1) year for the subsequent offence, from the dateof revocation letter;c) All transactions (including application for product registration, application for change ofproduct registration holder, application for change of manufacturing site) for theadulterated product registration holder shall be frozen for six (6) months for the firstoffence and one (1) year for the subsequent offence, from the date of cancellationletter from the Authority.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 128
Drug Registration Guidance Document (DRGD)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 | 129
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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