DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)8.6 POST-REGISTRATION PROCESSRegistration status of a product shall be valid for five (5) years or such period as specifiedin the registration certificate (unless the registration is suspended or cancelled by theAuthority).Upon approval for product registration by the Authority, applicants shall fulfill allcommitments and conditions imposed during approval of the product registration and shallbe responsible for the maintenance of the product in terms of quality, safety and efficacythroughout the validity period of registration. Failure to do so may result in rejection ofapplication for renewal of product registration.The Authority shall be notified of any changes to the product‟s efficacy, quality and safety,as described in detail at Section E: Post-Registration Process.8.7 REJECTED APPLICATIONAs stipulated in Regulation 18, CDCR 1984:a) Any person aggrieved by the decision of the Authority or the Director of PharmaceuticalServices, a written appeal may be made to the Minister of Health Malaysia;b) All notice of appeals shall be made within fourteen (14) days from the date ofnotification from the Authority;- A period of 180 days from the date of notice of appeal is given for submission of anyadditional information/ supplementary data/ documents for New Drug Products andBiologics.- A period of 90 days is allowed for other categories of product.- The appeal shall not be considered if all the required information is not submittedwithin the specified timeframe given. Any request for extension of this periodshall not be considered too.c) Any decision of the Minister made on an appeal shall be final.Re-submission for product registration of a rejected application due to reason of safety andefficacy shall not be accepted within two (2) years after the rejection. However, if theproduct is registered in the reference countries, submission of application can be madeearlier.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 82