DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEcontaining Propolis (for oral use), please state:- “This product contains propolis and may causesevere allergic reactions including fatalanaphylactic reaction in susceptible individuals.- Asthma and allergy sufferers may be at a greaterrisk.”Updates according to the circular (100)dlm.BPFK/PPP/01/03Jld. 2, 21 January 2013: Pemansuhan Pengeluaran SijilPerakuan Pendaftaran Produk (SPP), i.e.:7.January2013Section A,8.5.3 Certificateof RegistrationForm 1 (Certificate of Registration) for a product with theprovisions, conditions, limitations and etc. of the registration, asstipulated in Regulation 8(8) of CDCR 1984, has been deletedfrom the regulation in year 2006 via amendment of PU(A)336/06. Therefore, the certificate will no longer be issued by theAuthority.Circular(100)dlm.BPFK/PPP/01/03Jld. 2, 21 January 2013:Pemansuhan PengeluaranSijil Perakuan PendaftaranProduk (SPP)Applicant shall refer to the product registration approvalnotification sent by the Authority or the Approved ProductRegistration List in NPCB website.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 488
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 EvaluationCommittee No. 5/2013,6 March 2013Amendment from:3.March2013Appendix 9:LabellingRequirementsPatient Information Leaflet (PIL) or in Bahasa Malaysia knownas Risalah Maklumat Ubat Pesakit (RiMUP), is compulsory forproducts containing scheduled poison which are selfadministeredby 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/14,14 March 2013National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 489
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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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