DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCE3.January2013Section E, 14.Maintenance ofRegistrationAt 14. Maintenance of Registration:Addition of the following paragraph:In order to maintain registration of an imported product, startingon 1 st January 2014, applicant shall comply with GMPrequirement as stated in the directive issued by the Director ofPharmaceutical Services under Regulation 29, CDCR 1984Arahan Bil. 1 Tahun 2012 Syarat Pendaftaran ProdukFarmaseutikal Dari Luar Negara Berkaitan Keperluan AmalanPerkilangan Baik (APB) (Reference: Circulars Bil (25) dlmBPFK/PPP/01/03 Jld 1 and Bil (96)dlm.BPFK/PPP/01/03 Jld. 2).The Authority shall not consider any renewal application thatfails to comply with the stipulated requirement.At 16.2.2 Conditions on Good Manufacturing Practice (GMP):Addition of a hyperlink of Bil (96)dlm.BPFK/PPP/01/03 Jld. 2), 28December 2012: Surat Pekeliling Bagi Direktif Mengenai SyaratPendaftaran Produk Farmaseutikal Dari Luar Negara BerkaitanKeperluan Amalan Perkilangan Baik (APB)Directive Bil (25) dlmBPFK/PPP/01/03 Jld 1, 9February 2012: DirektifMengenai SyaratPendaftaran ProdukFarmaseutikal Dari LuarNegara BerkaitanKeperluan AmalanPerkilangan Baik (APB)andCircular(96)dlm.BPFK/PPP/01/03Jld. 2, 28 December 2012:Surat Pekeliling BagiDirektif Mengenai SyaratPendaftaran ProdukFarmaseutikal Dari LuarNegara BerkaitanKeperluan AmalanPerkilangan Baik (APB)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 484
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 | 485
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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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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