DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)9.1.3 PATIENT INFORMATION LEAFLETPatient Information Leaflet (PIL) or in Bahasa Malaysia known as RisalahMaklumat Ubat Pesakit (RiMUP), is compulsory for products which are selfadministeredby patients, including:a) Scheduled poisons (Category A);b) Over-the-Counter, OTC products (Category X);c) Health supplements with high claims (disease risk reduction).For details, please refer to:i) Direktif Penguatkuasaan Keperluan Mengemukakan Risalah Maklumat Ubatuntuk Pengguna (RiMUP) Bil. 5 Tahun 2011 Bil (15) dlm BPFK/PPP/01/03 Jld 1ii) Garispanduan Pelaksanaan Risalah Maklumat Ubat untuk Pengguna (RiMUP)The draft copy of the PIL in both English and Bahasa Malaysia shall be submitted forevaluation.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 352
Drug Registration Guidance Document (DRGD)9.2 SPECIFIC LABELLING REQUIREMENTSPlease refer Table 2: List of Substances Which Requires Specific LabellingRequirements and Table 3: Details of Specific Labelling Requirements.Table 2: List of Substances Which Requires Specific Labelling Requirements:NO.SUBSTANCES1. 5-ALPHA REDUCTASE INHIBITOR (5-ARI)2. ACE INHIBITORS3. ACETYLSALICYLIC ACID (ASPIRIN)4. ACTIVATED CHARCOAL/ ATTAPULGITE5. ALBENDAZOLE & BENZIMIDAZOLE ANTIHELMINTICS6. ALFALFA (MEDICO SATIVA)7. ALLOPURINOL8. ALPHA DIHYDROERGOCRYPTINE9. ALPRAZOLAM10. AMIODARONE11. ANTIDEPRESSANTS12. ANTIEPILEPTICS13. ANTIPSYCHOTIC AGENTS14. APOMORPHINE15. ARGININE16. ARIPIPRAZOLE17. ASPARTAME18. BEE POLLEN19. BENZOYL PEROXIDE20. BENZYL ALCOHOL21. BLACK COHOSH (CIMICIFUGAE RACEMOSAE)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 353
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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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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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