DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)No.ParticularsConvenientPackCombinationPack(Combo Pack)4. New indication No Yes5. Sale of product6. ExampleCan be soldindividually or asa packConfinement Setor Set JamuBersalinOnly to be soldas a packKlacid HP7(for treatment ofpeptic ulcerdiseasesassociated withH. pyloriinfection)17. POST-MARKETING ACTIVITIES17.1 PHARMACOVIGILANCE17.1.1 ADVERSE DRUG REACTION REPORTING AND SAFETY UPDATESIn accordance with Regulation 28 : Reporting adverse reaction under Control ofDrugs and Cosmetics Regulations 1984, Sale of Drugs Act 1952 (amendment 2006),the product registration holders or any person who possesses any registeredproduct shall inform immediately the Director of Pharmaceutical Services of anyadverse reaction arising from the use of the registered product.All product registration holders must ensure that a pharmacovigilance system is inplace by the company and appropriate action is taken, when necessary.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.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 123