DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Level of claimsRequirements for GMPGeneral/ Functionala) Malaysia Guidelines on Good Manufacturing Practice forTraditional Medicine and Health Supplement latest edition.Orb) The accepted standards for GMP will be determined bythe category the product is classified in the country oforigin.For example, if the product is classified as food in thecountry of origin, GMP certificate of food standard issuedby relevant country authority will be accepted on conditionthat the standards are similar to those practices inMalaysia.Orc) If the product is not regulated in the country of origin anddoes not require GMP certification, the manufacturer willhave to produce a GMP certificate issued by anindependent body recognised by the Authority. Informationincluding the standard/ regulations/ legislation to which theinspection was based upon must be mentioned.Disease RiskReductiona) Malaysia Guidelines on Good Manufacturing Practice forTraditional Medicine and Health Supplement latest editionOrb) The Pharmaceutical Inspection Convention andPharmaceutical Inspection Co-operation Scheme (PIC/S)Standards.Orc) GMP certificates issued by relevant country authority willbe accepted on condition that the standards are similar toPIC/S StandardsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 190
Drug Registration Guidance Document (<strong>DRGD</strong>)6. CONTRACT MANUFACTURERContract manufacturer is aplicable when product owner is not the product manufacturer7. SECOND SOURCE INFORMATIONAn application for a second source may be considered where deemed necessary. Thissecond source product shall be the same as the first product in all respects except for thesite of manufacture.8. PRODUCT CONTAINING PREMIXPremixed active ingredient(s) is a combination of two or more active ingredients that arepreviously manufactured by a different manufacturer.Certificate of GMP for manufacturer/ supplier is required for the premixed ingredient(s) informulation. The requirements for GMP are same as in Field 5 as above.9. REPLACEMENT PRODUCTA product registration holder is not allowed to register/ hold two or more products withsimilar formulation (same active ingredient of raw material, strength and dosage form) atany one time unless product variant.Letter of justification for replacement by product holder is required.10. OTHER MANUFACTURERAny manufacturer involved in Assembly, Fill & Finish, Active Ingredients, Packing, Labelingetc.11. IMPORTED PRODUCTSImported product needs to be declared.SECTION A: PRODUCT PARTICULARSProduct Description:State, briefly, visual and physical characteristics of the product, including as in thefollowing Table 8 (where applicable):National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 191
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Page 140 and 141: Drug Registration Guidance Document
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 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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