DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 106
Drug Registration Guidance Document (DRGD)No.2.Type I: Minor changeReplacement, addition or deletionof company logo on the packagingcomponents (without any changeson graphic or label content)3. Change in product owner4. Change in importer/ store address5.6.7.8.Change or addition of imprints,bossing or other markings (exceptscoring/ break lines) on tablets orprinting on capsules, includingreplacement, or addition of inksused for product markingChange in shape or dimensions ofthe container or closure without anyother changesChange in pack size of the drugproduct (Finished product), withoutchange in primary packagingmaterial; or change in the numberor units (e.g. tablets, ampoules) in apack; or change in volume of nonsterile preparationsTightening of specification limits ofdrug product (finished product)and/or drug substance (activeingredient)VariationType II: Major changeChange in content of leaflet orprescribing information/ PatientInformation Leaflet (PIL)/ Summaryof Product Characteristics (SPC)Change in content of label inclusiveof change in graphics/ artworkChange in manufacturing process ofthe finished productChange in overage of activeingredient or excipientReplacement of an excipient with acomparable excipient and/or changein content of excipientChange in batch sizeChange in hard capsule shell (color,size or source)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 107
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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