DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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