DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Under the CDCR 1984, Regulation 8(9): Any person who knowingly supplies anyfalse or misleading information to the Authority with his application for theregistration of a product commits an offence.c) Responsible for all matters pertaining to quality, safety and efficacy of theregistered product, including:i. Data updates on product quality, safety and efficacy or current GoodManufacturing Practice (cGMP) compliance of the manufacturers (andrepackers, where applicable).Under the CDCR 1984, Regulation 8(5): Any change in any document,item, sample, particulars or information which shall be notified in writing bythe applicant to the Authority within fourteen (14) days from the date ofsuch change.ii. Any decision to withdraw the registration of the product with reasons.d) To notify the Authority of any change in correspondence details, including thename, address, contact person, telephone number, fax number and email;e) To notify the Authority immediately upon cessation of the applicant as theproduct registration holder;3.3 HOW TO APPLYFor registration of products, only web-based online submissions via QUEST athttp://www.bpfk.gov.my shall be accepted.To conduct transactions via QUEST system, the applicant must first register amembership for QUEST system with NPCB and purchase a USB Token thatcontains a User Digital Certificate, from Digicert Sdn. Bhd., which shall be installedto the applicant‟s computer.For details, please refer to Frequently Asked Questions on QUEST System.For charges regarding QUEST USB token, please refer to Appendix 1: Fees.The applicant shall be responsible for any act of fraudulence or misuse pertaining toits authorized QUEST USB token(s).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 56
Drug Registration Guidance Document (<strong>DRGD</strong>)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 | 57
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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