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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)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.<strong>BPFK</strong>/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.<strong>BPFK</strong>/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 | 485

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