DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)Product registration holders are required to monitor and report any product safetyissues that arises locally or internationally to the NPCB and comply with all safetyrelateddirectives issued by the Authority.The product registration may be cancelled if the product registration holder fails toinform the Authority of any serious adverse reactions upon receipt of such reports.The WHO encourages reporting of ALL adverse drug reactions.For further information, please refer Malaysian Guidelines for the Reporting &Monitoring.17.2 POST-MARKET SURVEILLANCEa) Samples of products registered by the Authority may be taken and tested forcompliance with official or pharmacopoeia standards or specifications agreed by themanufacturer;b) If a sample fails to meet adequate specifications, the product registration holder willbe issued a warning. Unless the failure is serious enough to justify recall of theproduct, the product registration holder has up to thirty (30) days to identify thesource/ cause of quality defect and actions to be taken to improve quality.17.2.1 PRODUCT COMPLAINTSa) The product registration holder should notify the Director of PharmaceuticalServices of any product quality related problems (with registered products) thatthe holder is aware of;b) It is also the responsibility of the prescribers, the pharmacists, as well as all otherhealth professionals who come into contact with the drug to report.17.2.2 PRODUCT RECALLSa) Recalls of defective or unsafe products are instituted by the Authority, supportedby the Pharmaceutical Services Division, Ministry of Health Malaysia;National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 118