DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO.NON-PERMISSIBLE INDICATIONS6. Tibi / Tuberculosis7. Asma / Asthma8. Kusta / Leprosy9. Kanser / Cancer10. Kepekakan / Deafness11. Ketagihan dadah / Drug addiction12. Hernia atau pecah / Hernia or rupture13. Penyakit mata / Disease of the eye14. Hipertensi (Darah Tinggi) / Hypertension15. Sakit otak / Mental disorder16. Kemandulan / Infertility17. Kaku / Frigidity18.Lemah fungsi seks atau impoten / Impairment of sexual function orimpotency19. Penyakit venerus / Venereal disease20.Lemah urat saraf atau aduan atau kelemahan lain timbul daripadaatau perhubungan dengan perhubungan seks / Nervous debility orpother complaint of infirmity arising from or relating to sexualintercourse.2.4 PRODUCT NAMEa) If the product owner wishes to use the formulary name, any amendments madeto the product formulation such as the addition of active ingredients, removal ofactive ingredients or change in strength of active ingredients is not permitted.b) A brand name in front of the formulary name shall be requested to be added, inorder to differentiate and identify their product from products with the sameformulary name.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 268
Drug Registration Guidance Document (<strong>DRGD</strong>)c) Any product name which is the same or similar either in writing/ pronunciation,with the product name of an adulterated product is prohibited.d) 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 | 269
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 230 and 231: ATTACHMENT 2Drug Registration Guida
Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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