DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)7) However, the existing PRH is allowed to deplete the stocks and still holds theresponsibility in the event of pharmacovigilance issues or quality defectsassociated with the product arises during the interim transfer period.8) The existing PRH or new approved PRH shall submit a written request to depleteexisting stocks after DCA approval for the transfer. The PRH who submit therequest shall holds the responsibility in the event of pharmacovigilance issues orquality defects associated with the product.9) Application shall be rejected if the applicant fails to provide satisfactory requireddocuments within 30 working days starting from the first correspondence date.16.3.3 MODE OF APPLICATIONMode ofApplication/sRequirements ofApplicationLocation for Submission of HardCopiesManual- Two (2) hard copies ofcompleted ApplicationForm BPFK-430.5 (refer16.3.7)- Borang PenyerahanPermohonan (BPFK-001) and processing fee(refer 16.3.4)- Original supportingdocuments (refer16.3.6)Finance Department:a) One(1) copy of completedApplication Form BPFK-430.5;b) Processing Fee.c) Borang PenyerahanPermohonan (BPFK-001)Secretariat:a) One(1) copy of completedApplication Form BPFK-430.5;b) Original supporting documents.c) Borang PenyerahanPermohonan (BPFK-001)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 116
Drug Registration Guidance Document (DRGD)16.3.4 PROCESSING FEE AND PAYMENT MODE1. NON-REFUNDABLE processing fee.For Traditional Product : RM 500.00For Poison/ Non-Poison product : RM 1,000.002. The processing fee with attachment, as stipulated in 16.3.3 Mode ofApplication; shall be paid in the form of a bank draft/ banker‟s cheque/ moneyorder/ postal order, made payable to "Biro Pengawalan FarmaseutikalKebangsaan” at Finance Department of NPCB.3. Application/s without correct processing fee will not be accepted forprocessing.4. Foreign currencies are not acceptable.16.3.5 PROCEDURE OF APPLICATION1. The existing PRH shall submit an application accordingly, as stipulated in16.3.3 Mode of Application.2. Upon receipt of application plus processing fee, the Finance Department ofNPCB shall confirm the payment and issue a receipt.3. The secretariat shall evaluate the complete paid application.4. The evaluated application shall be tabled to DCA for approval/ rejection. Forrejected application, the applicant shall be notified.5. Upon approval, the Secretariat shall issue a notification of transfer approval,to the proposed new PRH and a notification of termination to the existingPRH.6. Please refer 16.3.9 Flowchart for the Change of Product Registration Holder.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 117
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PART III: NON-CLINICAL DATADrug Reg
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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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