DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)The NPCB reserves the rights to approve or reject any application for the QUESTmembership.4. FEESUnder the CDCR 1984, Regulation 8(3): The Authority may charge any applicantsuch costs as it may incur for the purpose of carrying out any evaluation orinvestigation prior to the registration of any product.Any payment made shall NOT be REFUNDABLE once the application has beensubmitted and payment confirmed.Applications without the correct fees will not be processed.4.1 FEES IMPOSEDPlease refer to Appendix 1: Fees for fees imposed, which include:a) Charges for USB Token of QUEST Membership;b) Processing and Analysis Fee for Product Registration;c) Charges for Application of Licence;d) Charges for Amendments to Particulars of a Registered Product; ande) Fee for Certificates.4.2 MODE OF PAYMENTThe processing fee and any other charges shall be paid in the form of bank draft/banker‟s cheque/ money order/ postal order made payable to “Biro PengawalanFarmaseutikal Kebangsaan”.A separate bank draft/ banker‟s cheque/ money order/ postal order are required foreach application.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 58
Drug Registration Guidance Document (DRGD)5. TYPES OF APPLICATION5.1 REGISTRATION OF PRODUCTS5.1.1 APPLICATION FOR PRODUCT REGISTRATION FOR THEFOLLOWING CATEGORIES:a) New Drug Products;b) Biologics;c) Generic;d) Health supplements; ande) Natural Products.For details, please refer to Section A, 1.2 Categories of Product and SectionB: Product Registration Process.5.1.2 REGISTRATION OF COMBINATION PACK (COMBO PACK)a) Refers to products which are packed together in combination for atherapeutic regimen such as for the treatment of Helicobacter Pylori,Hepatitis C, etc.).b) Shall be registered as a single product.c) Must consist of registered products only:i. Where a combination pack consists of registered and unregisteredproducts, the unregistered product needs to be registered first, priorto submission of the application;ii.Where a combination pack consists of registered products fromdifferent product owners/ PRH, letters of authorization whichinclude product name and product registration number from eachproduct owner shall be submitted.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 59
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PART III: NON-CLINICAL DATADrug Reg
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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