DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)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