DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)c) batch size;d) packaging materials, thickness of same packaging materials, pack sizes;(Note: Use of different packaging material shall be supported with stability study report.)e) manufacturer of API; andf) source of excipients;EXCEPT differences in shape, embossment and thickness of tablet, in order to avoidchange in product identity and subsequently causing confusion.The manufacturer shall declare with support of manufacturing validation process data thatthere is no change in formulation, specification of active ingredient(s) and excipient(s), andfinished product for the second source product compared to the first source.For pharmaceutical product, no third source is allowed for same product unless inemergency situation such as outbreak of infectious disease.For biologics, a third source may be considered if justified.8.1.7 VARIANTSVariants refer to products with differences in terms of fragrance/ flavour or consequentlycolour.When variants are registered:a) The variants should only differ in terms of fragrance/ flavour and colour.b) Product name of the variants shall remain the same, with the addition of an identifyingvariant name.c) Each variant shall be registered as one (1) product with a different registration number.A maximum of five (5) variants to the registered product may be considered for thefollowing dosage forms:a) Products Containing Scheduled PoisonONLY for pediatric oral liquid preparationsb) Products Containing Non-Scheduled Poisoni) Lozenges;ii) Chewable tablets;National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 76
Drug Registration Guidance Document (<strong>DRGD</strong>)iii) Effervescent powders/ tablets;iv) Powder;v) Granule;vi) Oral liquid;vii) Dental preparations (rinses, dentifrices);viii)Medicated soaps (bar, liquid); andix) Vaginal creams and douches.8.1.8 LANGUAGEAll data and information including supporting documents for product registration such ascertificates, letters and product labels shall be in English or Bahasa Malaysia.8.2 SUBMISSION OF APPLICATIONApplication of product registration shall be submitted via the online QUEST system atwww.bpfk.gov.my.Applicant shall ensure all data requirements needed to support the application is fulfilledbefore submission.Upon submission, the application shall be given a call number for reference, which isspecific to a particular product. Applicant shall refer to this call number during allcorrespondence pertaining to the registration of the product.Applicants are advised to read the explanatory notes as stated in Appendix 11: Guidelineon Filling the Online Application Form for Product Registration via Quest System, and alsorelevant ASEAN or ICH guidelines and checklists, for full information on requirement forproduct registration.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 77
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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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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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