DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Latin Compendium NameTanacetum VulgareThuja OccidentalisTurnera DiffusaTrigonella foenumgraecumTrillium ErectumTussilago FarfaraCommon/ ChineseNameTansyArbor VitaeDamianaFenugreekBethrootColtsfootRemarksV Venenum Bufonis Chan SuViscum AlbumEuropean MistletoeX Xanthoxylum Americanum Prickley AshTable 11: Restricted in PregnancyNo.Latin Compendium Name1. Zingiber Officinalis GingerCommon/Chinese NameRemarks> 1g dryweight/dayNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 296
Drug Registration Guidance Document (<strong>DRGD</strong>)2.7.4 PROHIBITED VISUAL/ GRAPHICS/ STATEMENT ON PACKAGING MATERIAL (LABEL, BOX, PACKAGEINSERT OR PATIENT INFORMATION LEAFLET)General requirement:The graphics printed on outer and inner label has to be standardized to avoid confusion to the customers.Table 12:No. Subject Matter Example(s) Notes1. Marketing strategy Example:“Money back guarantee”“Buy 1 free 1”“ Backed by RM5 millionproduct Liability Insurance”Such statements are prohibited onlabels, as per Medicines (Advertisementand Sale) Act 1956 requirements2. Usage guide which promotes use ofother product(s)Example:“After consumption of thisproduct (Product A), for betterresults, it is recommended totake Product B”Not allowed3. Consumer testimonial Prohibited on product labelNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 297
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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