DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)SECTION E: POST-REGISTRATION PROCESS14. MAINTENANCE OF REGISTRATIONRegistration 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).Application for renewal of product registration of a product shall be done within six(6) months prior to the expiry of the validity period of a product registration. Afterthe expiry date, status of product registration shall change to status of expired, andapplication for renewal of the product registration can‟t be submitted.In order to maintain registration of an imported product, starting on 1 st January 2014,applicant shall comply with GMP requirement as stated in the directive issued bythe Director of Pharmaceutical Services under Regulation 29, CDCR 1984 ArahanBil. 1 Tahun 2012 Syarat Pendaftaran Produk Farmaseutikal Dari Luar NegaraBerkaitan Keperluan Amalan Perkilangan Baik (APB) (Reference: Circulars Bil (25)dlm BPFK/PPP/01/03 Jld 1 and Bil (96)dlm.BPFK/PPP/01/03 Jld. 2). The Authorityshall not consider any renewal application that fails to comply with the stipulatedrequirement.15. WITHDRAWAL OF PRODUCT REGISTRATIONThe Product Registration Holder shall inform the Authority pertaining to decision towithdraw the registration of a product before the end of the validity of suchregistration and shall state the reasons for the decision. The onus is on the holder toinform the manufacturer/ contract manufacturer.The registration of a product, once withdrawn, shall not be reinstated and certificateof registration of the withdrawn product shall be invalid.A new application shall be submitted if the product registration is required again at alater date.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 105