DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)e) Applicant shall submit sample of natural product for laboratory testing to the Centre forQuality Control, NPCB within fourteen (14) days from date of confirmed payment.Failure to do so within thirty (30) days from the date of the payment shall result inrejection of the application;8.1.5 MULTIPLE APPLICATIONSSeparate application for product registration shall be required for each product for thefollowing conditions:a) Products containing the same ingredients but made to different specifications, in termsof strength/ content of ingredient(s), dosage form, description, etc.; orb) Different manufacturer.However, different packings (materials) or pack sizes (quantity/ volume) of a product madeby the same manufacturer to the same specifications, formulation and dosage form(including parenteral preparations, peritoneal dialysis fluids and haemofiltration solutionswhich are introduced into human bodies) shall require only one application for productregistration. The product registration shall be for the packings and pack sizes stated in theregistration documents only.Note:Registration of same product in all aspects but with different product name by the samePRH is not allowed by the Authority.8.1.6 SECOND OR THIRD SOURCEIt is defined as product which is the same as the product from first source in all aspects,except for the site of manufacture.An application for a second source may be considered by the Authority but only withjustification.For biologics, a third source may be considered if justified.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 76
Drug Registration Guidance Document (<strong>DRGD</strong>)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;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.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 77
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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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