DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)h) Men‟s Health/ Kesihatan Lelaki“Traditonally used…./ “Digunakan secara tradisional….1. For energy and men‟s health/ for vitality/ untuk memulihkan tenaga dankesihatan lelaki.i) Skin And External Usage/ Kulit Dan Kegunaan Luar“Traditionally used…../ “Digunakan secara tradisional…1. For symptomatic relief of pain and itch associated with insect bites/untuk melegakan sakit dan gatal-gatal digigit serangga.2. For relief of minor burns/ untuk melegakan melecur ringan.3. For relief minor cuts/ untuk melegakan luka-luka ringan.4. For relief of minor bruises/ untuk melegakan lebam yang ringan.5. For reducing pimples/ untuk mengurangkan jerawat.6. To help maintaining healthy skin, nail and hair/ untuk kesihatan kulit,kuku dan rambut.7. For reducing pimples and mild itch/ untuk melegakan jerawat dangatal-gatal ringan.2.3.2 NON-PERMISSIBLE INDICATIONSTable 6:NO.NON-PERMISSIBLE INDICATIONS1. Penyakit atau kecacatan ginjal / Disease or defects of the kidney2. Penyakit atau kecacatan jantung / Disease or defects of the heart3. Kencing manis / Diabetes4. Epilepsi atau sawan / Epilepsy or fits5. Kelumpuhan / ParalysisNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 270
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 | 271
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Page 230 and 231: PART III: NON-CLINICAL DATADrug Reg
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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