DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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.For pharmaceutical products which were submitted for registration before 2009,applicants shall ensure that stability study for the products at zone IV B has beenconducted and granted variation approval before submission of registration renewalapplication. Please refer circular (1)dlm.BPFK/PPP/01/03Jld.3, 5 April 2013 for moreinformation.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 The onus is on the holder toinform the manufacturer/ contract manufacturer.The registration of a product, once withdrawn, shall not be reinstated and certificateof registration of the withdrawn product shall be invalid.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 104
Drug Registration Guidance Document (DRGD)A new application shall be submitted if the product registration is required again at alater date.16. AMENDMENTS TO PARTICULARS OF A REGISTEREDPRODUCTThroughout the life cycle of a registered product, changes to improve the product‟sefficacy, quality and safety are likely to occur. Therefore, applicant shall inform theAuthority pertaining to any changes or amendment to particulars of a registeredproduct via applications.Starting on 1 st January 2014, applicant who wishes to apply for any application forimported products of which GMP requirement shall be considered, such as changeof manufacturing site and variation, shall comply with the requirement, as stated indirective issued by the Director of Pharmaceutical Services under Regulation 29,CDCR 1984 Arahan Bil. 1 Tahun 2012 Syarat Pendaftaran Produk FarmaseutikalDari Luar Negara Berkaitan 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 Authority shall not consider any application in which the requirement is failedto comply with.16.1 VARIATIONVariation refers to change of particulars of a registered product. No change of anyparticulars of a registered product shall be made without prior approval from NPCB.The registration of a product shall be reviewed for suspension or cancellation ifchanges are made without prior approval of the Authority.There are two types of variation, which are Variation Type I and Variation Type II:National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 105
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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