DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEii) Amendment of the following paragraph and addition oflink at 17.2 POST-MARKET SURVEILLANCEa) It is the prime responsibility of the holder to ensure productsmarketed are in accordance to the standards andrequirements of the Authority. Samples of productsregistered by the Authority may be taken and tested forcompliance with official or pharmacopoeia standards orspecifications agreed by the manufacturer;5. May 2013Section E:Post-RegistrationProcessb) Samples of products Registered products by the Authoritymay be taken sampled and tested for compliance withofficial or pharmacopoeia standards or specifications agreedby the manufacturer. Labels and package inserts of thesamples will also be checked to ensure compliance to therequirements as approved.c) The Authority will take necessary action on products whichdo not conform to the standards/ specifications andrequirements in the form of warnings or recalls. If a samplefails to meet adequate specifications, the productregistration holder will be issued a warning. Unless thefailure is serious enough to justify recall of the product, Theproduct registration holder has up to thirty (30) days toidentify the source/ cause of quality defect and actions to betaken for to improvement quality.Memo from Center for PostRegistration of Product Bil(87)dlm.BPFK/17/SV/21.16,10 May 2013National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 495