DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)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:Table XIV:No.1.Type I: Minor changeChange in name of manufacturerand/or other manufacturers withoutany change in address of siteVariationType II: Major changeChange of product nameNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 105