DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)c) Product names which are not permitted to be registered are as specified inTable 7 below:No. Non-Permissible Product Names Example1.2.3.4.5.Prohibited use of disease names asstated in the Medicines (Advertisementand Sale) Act 1956 (Revised 1983)Prohibited use of a single activeingredient as a product name inproducts containing more than oneactive ingredient unless product namecontains words such as „Plus,Compound, Complex, HerbanikaProhibited use of superlative - Nameswhich indicates superiority inefficacyProhibited use of spelling of wordswhich may cause confusionWords which involve names of/partthereof:i) 20 disease names prohibited in theMedicines (Advertisement and Sale)Act 1956 (Revised 1983)ii) Other diseases without scientific proofiii) Prohibited indicationProhibited use of names which maycause ambiguityAmbiguous product nameExample :Diabetes, Asthma, CancerExample :Tongkat Ali Capsule ----But product contains tongkat ali,ginseng, ect.Example :Power/ Kuasa, Superior, Pure,Mustajab, Safe, Healthy/ Sihat,Penawar/ Shifa, VIP, Good, Heal/Sembuh, Premium, Mustajab,Men/ Women/ Children Complete,Men/ Women/ Children Enriched,Paradise/ Syurga, MenawanExample :a) Go Out = GOUT (label)b) UTixExample:B For Energy?National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 272
Drug Registration Guidance Document (<strong>DRGD</strong>)No. Non-Permissible Product Names Example6.7.8.9.10.11.12.Prohibited use of names which may beoffensive or indecentProhibited use of product names whichare incoherent with the approvedindicationName containing a product claim whereasproduct is indicated for more than theapproved indicationProhibited use of product names whichhas elements of ludicrous beliefStatements referring to ancient believe/negative spirits/ supernatural powerProhibited use of product names similarto the existing approved product namesProduct names similar to the spelling andpronunciation of words of the existingproduct namesProhibited use of product names whichmay cause ambiguity in the nature ofproduct (drug/ food/ beverage)Product names similar to a food/ beverageproductProhibited use of product names whichrepresents professional advice oropinion or referring to the professionProhibited use of product names whichrepresent weight loss/ slimmingpropertiesExample:SENXBIG=SEnXBIG(label)Sexy, Enjoy, Paradise,Heavenly, Blue boy, Casanova,Desire(Dezire),Sensual(Xenxual),Asmara,SyokExample:Cough Syrup X= Approvedindication for cough, dizziness, fluand itchExample:Words such as miracle, magic,magical, miraculous, saintly,heavenlyExample:Tenormin vs Tenormine vsTenormyRe-Liv vs Re-LifExample:Juice, Health drink, Beverage,KookyExample:Dr Sunny, Dr Noortier RooiboseTea, Professor, Herbalist, DoctorExample:Slim, Langsing, Trim, Trimnfit,Sleen, Kurus, Susut perutNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 273
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Page 222 and 223: Drug Registration Guidance Document
Page 230 and 231: PART III: NON-CLINICAL DATADrug Reg
Page 232 and 233: - All information must be provided
Page 242 and 243: 1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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