DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEthis product or Sila merujuk kepada ahli farmasi/ doktorsebelum mengambil produk ini.”For product with an indication “To relieve symptomsfor…. (any illness)” or “untuk mengurangkan tandatanda/simptom….”, please state:- “Please consult your pharmacist/ doctor if symptomspersist/ worsen or Sila merujuk kepada ahli farmasi/doktor jika simptom berlarutan/ bertambah teruk.”“This is a traditional medicine/Ini adalah ubat tradisional.”OR “This is a homeopathy medicine/Ini adalah ubathomeopati.”Unless otherwise supported, all herbal/ traditionalproducts label shall state the following generalcautionary statement, EXCEPT for product withindication for men‟s health or product for children useonly:“Pregnancy and breastfeeding: Insufficient reliabledata”- Amendment at 2.7.2 Specific Labelling Statements/ Warning& Precautions:a) For product containing Royal Jelly: Addition of “(for oraluse)” after the word of “Royal Jelly”.b) Addition of new active ingredient i.e. “For productNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 478
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 | 479
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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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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