DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCE4.January2013Section A,1.3.2Classification ofFDI ProductsAddition of examples and a hyperlink of the related circularfor gamat (Stichopus spp.) at a) Main Criteria, number ii)Substances or ingredients used for therapeutic purposes shallnot be added to food. For examples: gypsum fibrosum, pearlpowder and gamat (stichopus spp.).Circular(98)dlm.BPFK/PPP/01/03Jld. 2, 8 January 2013:Keperluan PendaftaranProduk Food-DrugInterface yangmengandungi bahan aktifgamat (Stichopus spp)5.January2013Section D, 13.2LicenseApplicationFormAddition of a hyperlink at number 4, Import License, regardingrequirement of Certificate of Analysis (CoA) for each batch ofregistered product which is imported into Malaysia.Circular(99)dlm.BPFK/PPP/01/03Jld. 2, 11 January 2013:Sijil Analisa (Certificate ofAnalysis, COA) UntukSetiap Kelompok ProdukBerdaftar Yang DiimportKe MalaysiaNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 482
Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCE6.January2013Appendix 5,Guideline onRegistration ofNaturalProducts- Amendment at 2.1.3 Prohibited/ Banned Ingredients:a) Table 1: Botanicals (and botanical ingredients) containingscheduled poisons as listed under the Poisons Act 1952,for ingredient “Valerian”, as follows:Species: Deletion of “Extract only”Constituent(s) of concern: Addition of “Valepotriates”.b) Table 4: List B: Botanicals which may be Adulterated withAristolochic Acid:Addition of botanical name starting at Cocculusorbiculatus DC. [Common or Other Names: Mokuboui(Japanese)] to the last botanical namesStephania tetrandra S. Moore and Vladimiria souliei(franch.) LingMemo from Sub-Section ofComplementary Medicine(53)dlm.BPFK/PPP/06/17Jilid 29, 18 January 2013- Amendment at 2.7.1 Statement to be stated on productlabel:“If symptoms persist, please consult a doctor.” and “This is anatural medicine/ Ini adalah ubat tradisional.” OR “This is ahomeopathy medicine/ Ini adalah ubat homeopati.” TOFor product with an indication “For general health/ wellbeing” or “Untuk kesihatan umum”, please state:- “Please consult your pharmacist / doctor before takingNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 483
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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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