Transcription of APPENDIX 9: LABELLING REQUIREMENTS
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APPENDIX 9: LABELLING REQUIREMENTS
Drug Registration Guidance Document (DRGD) National Pharmaceutical Regulatory Division, Ministry of Health Malaysia. Second Edition, Sept 2016. Revised July 2018 Page | 411 APPENDIX 9: LABELLING REQUIREMENTS This APPENDIX comprises of two (2) parts: a) General LABELLING REQUIREMENTS for: i) Section D : Label (Mock-Up) for Immediate Container and Outer Carton ii) Section D : Proposed Package Insert (PI) iii) Section E8/ F8 : Consumer Medication Information Leaflet (RiMUP) b) Specific LABELLING REQUIREMENTS Drug Registration Guidance Document (DRGD) National Pharmaceutical Regulatory Division, Ministry of Health Malaysia. Second Edition, Sept 2016. Revised July 2018 Page | 412 GENERAL LABELLING REQUIREMENTS The following information in Table 1 shall present on the label of a product at outer carton, immediate container or blister/ strips: No.
(e.g. X Brand Paracetamol Tablet 500mg) • The generic name cannot be used alone as product name but in combination with another name, other than the generic name. ... Tongkat Ali Capsule ---- But product contains tongkat ali, ginseng, ect. Drug Registration Guidance Document (DRGD)
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