DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)APPENDIX 1:FEESOutline:1.1 Charges for USB Token of QUEST Membership;1.2 Processing and Analysis Fee for Product Registration;1.3 Charges for Application of Licence;1.4 Charges for Amendments to Particulars of a Registered Product; and1.5 Fee for Certificates.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 130
Drug Registration Guidance Document (<strong>DRGD</strong>)1.1 CHARGES FOR USB TOKEN OF QUEST MEMBERSHIPApplicationcategoryFirst-time UserSupplementaryUserRenewal of USBtokenChargesPackage A(USB Token of 2-years validity + Guide Manual) : COST RM335Package B(USB Token of 1-year validity + Guide Manual) : COST RM320Package A(USB Token of 2-years validity + Guide Manual) : COST RM335Package B(USB Token of 1-year validity + Guide Manual) : COST RM320Package C1(New USB Token of 2-years validity) : COST RM280Package C2(Utilized old USB Token of 2-years validity) : COST RM100National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 131
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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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