DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)8.2 SUBMISSION OF APPLICATIONApplication of product registration shall be submitted via the online QUEST system atwww.bpfk.gov.my.Applicant shall ensure all data requirements needed to support the application is fulfilledbefore submission.Upon submission, the application shall be given a call number for reference, which isspecific to a particular product. Applicant shall refer to this call number during allcorrespondence pertaining to the registration of the product.Applicants are advised to read the explanatory notes as stated in Appendix 11: Guidelineon Filling the Online Application Form for Product Registration via Quest System, and alsorelevant ASEAN or ICH guidelines and checklists, for full information on requirement forproduct registration.8.3 SCREENING OF APPLICATIONAfter an online submission of the product registration application has been done, theapplication shall be undergone an initial evaluation (or known as screening process) whichshall ensure the required data/ information of the submitted application are complete.Further evaluation shall be done after payment for the application has been made.8.3.1 SATISFACTORYOnly complete application shall be accepted and approved for payment.Upon approval from the screening process, applicant shall print three (3) copies of paymentvoucher and submit two (2) copies of payment voucher together with correct fees toFinance Department, NPCB for payment confirmation. Applicant shall keep a copy of thepayment voucher for future reference. A product reference number shall be given to theapplication upon payment confirmation.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 77