DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)h) Promotion of sale including product information;i) Product recall;j) Product disposal;k) The cost of product recall or product disposal;l) Clinical trials; orm) Records and statistics pertaining to manufacture, sale, supply, import or export ofany products.7. USE OF HALAL LOGOHalal logo may be used voluntarily on registered product label for the following categories,for both local and export market, provided that such products have been certified andapproved halal by the Malaysia Department of Islamic Development (Jabatan KemajuanIslam Malaysia, JAKIM):a) Non-scheduled poison, excluding parenteral dosage form and veterinary products;Reference: Circular (95)dlm.BPFK/PPP/01/03 Jld. 2b) Health supplements;c) Natural products; andd) Cosmetics.However, the logo is NOT allowed to be used on label of registered products other than thecategories as listed above.Only halal logo issued by JAKIM or any Islamic Body which is recognized by JAKIM shallbe accepted.Consideration by the Authority for use of halal logo on product label of such products shallbe based on application as it is not a mandatory requirement.Applicant shall submit application for variation type II to NPCB for approval to affix halallogo on product label of a registered product of which a halal certification has been granted.A copy of the halal certificate must be submitted as a supporting document.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 68
Drug Registration Guidance Document (DRGD)SECTION B: PRODUCT REGISTRATION PROCESSThe process of product registration ensures that pharmaceutical products are evaluated forits safety, efficacy and quality, whereas natural products are evaluated for its safety andquality, prior to being registered by the Authority and finally released into the market.8. FLOW OF REGISTRATION PROCESSFigure 4:Process of Product RegistrationApplicationRejectedNon-SatisfactorySubmission ofApplicationScreening ofApplicationSatisfactoryEvaluation ofApplicationRegulatoryOutcomeApprovedPost-RegistrationProcessRejectedAppealNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 69
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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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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