Resources
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637 result(s) found, displaying 626 to 637
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline- ICH M13 A
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH M4S; CPMP/ICH/2887/99 - Safety
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – EMEA/CHMP/QWP/49313/2005 Corr
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User guideThis document is for Australian sponsors and manufacturers of sterile medicines and active pharmaceutical ingredients (APIs) made or supplied in Australia.
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Compositional guidelinesCompositional Guideline: Lauryl Methacrylate/Sodium Methacrylate Crosspolymer Dispersion (40 per cent) permitted for use in listed medicines.
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Compositional guidelinesCompositional Guideline: Stearoyl Glutamic Acid permitted for use in listed medicines.
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Compositional guidelinesCompositional guideline Sorbitan Distearate permitted for use in listed medicines.
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Compositional guidelinesCompositional guideline for Nicotinamide mononucleotide permitted for use in listed medicines.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/HMPC/104613/2005 Rev. 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/239/95 Rev. 1, Corr.1*
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International scientific guidelines adopted in AustraliaEMA/HMPC/CHMP/CVMP/162241/2005 Rev. 3 adopted by the Therapeutic Goods Administration (TGA)
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ChecklistsThis checklist outlines key considerations for sponsors and manufacturers seeking to comply with Australia’s Unique Device Identification (UDI) requirements.