DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)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 | 83