DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCE1.March2013Appendix 5,Guideline onRegistration ofNaturalProducts- Replacement of information at 2.1.3 (c) ASEANHarmonisation Negative List of Ingredients with (c)Ingredients (Botanicals and Substance Derived fromAnimals) which are banned due to safety reasons.- Renumbering of tables in the appendix.Memo from Sub-Section ofComplementary Medicine(11)dlm.BPFK/PPP/06/17Jilid 30, 20 February 20132.March2013Appendix 8:List ofPermitted,Prohibited andRestrictedSubstancesAt 8.1.2 List of Restricted Active Ingredients and Combinations:Amendment on substance No. 16 Dextromethorphan from“Single Active Ingredient Tablet Formulation” to “Single ActiveIngredient in Tablet Form, including lozenges”Drug Evaluation CommitteeNo. 5/2013,6 March 2013Amendment from:3.March2013Appendix 9:LabellingRequirementsPatient Information Leaflet (PIL) or in Bahasa Malaysiaknown as Risalah Maklumat Ubat Pesakit (RiMUP), iscompulsory for products containing scheduled poison which areself-administered by patients.For details, please refer to Direktif Penguatkuasaan KeperluanMengemukakan Risalah Maklumat Ubat Pengguna (RiMUP)Bil. 5 Tahun 2011 Bil (15) dlm BPFK/PPP/01/03 Jld 1 andGarispanduan Pelaksanaan Risalah Maklumat Ubat untukPengguna (RiMUP)Memo from Center forPost-Registration ofProducts(16)dlm.BPFK/17/FV/14, 14March 2013National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 486
Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEPIL may also be submitted for OTC products in place of apackage insert (PI). However, if the product is intended to besold without a PI or PIL, the information required to beingincluded in the PI or PIL shall be included in the unit outercarton of the product.The draft copy of the PIL in both version of English and BahasaMalaysia shall be submitted for evaluation.Amendment to:Patient Information Leaflet (PIL) or in Bahasa Malaysiaknown as Risalah Maklumat Ubat Pesakit (RiMUP), iscompulsory for products which are self-administered bypatients, including:d) Scheduled poisons (Category A);e) Over-the-Counter, OTC products (Category X);f) Health supplements with high claims (disease riskreduction).For details, please refer to:iii) Direktif Penguatkuasaan Keperluan MengemukakanRisalah Maklumat Ubat untuk Pengguna (RiMUP) Bil. 5Tahun 2011 Bil (15) dlm BPFK/PPP/01/03 Jld 1iv) Garispanduan Pelaksanaan Risalah Maklumat Ubatuntuk Pengguna (RiMUP)The draft copy of the PIL in both English and Bahasa Malaysiashall be submitted for evaluation.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 487
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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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