DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 288
Drug Registration Guidance Document (<strong>DRGD</strong>)No. Subject Matter Example(s) Notes4. Clinical Trial results or anyinformation on clinical trial done onproductExample:“Clinically Tested”“Randomized Double BlindPlacebo Control Clinical Study”Such statements are prohibited onlabels, as per Medicines (Advertisementand Sale) Act 1956 requirement5. Photograph of product pioneer Not allowed6. Reference to Hadith/ Al-Quran/Bible/Prohibited on product labelReligious books7. Opinion of prominent figure(s) onproduct or its active ingredient/content8. Label design (graphic and color)similar to labels from anothercompanyExample:Opinion of product/formulation inventorProhibited on product labelProhibited on product label9. Statement on herbal origin Example:Source from theMountains of AlpsAllowed if proven trueNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 289
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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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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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