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623 result(s) found, displaying 26 to 50
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/237/95
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q2 (R1); CPMP/ICH/381/95
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S3A; CPMP/ICH/384/95
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S3B; CPMP/ICH/385/95
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/EWP/213056/2010.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline: CPMP/SWP/799/95
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - 3CC29a
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/257298/2018
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S7A; CPMP/ICH/539/00
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S8; CHMP/167235/2004
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S1C (R2); EMEA/CHMP/ICH/383/1995
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User guideWe have made templates for Product Information (PI) and Consumer Medicine Information (CMI) documents to assist sponsors lodging variation applications for solid-dose single ingredient paracetamol products affected by upcoming scheduling changes.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S4; CPMP/ICH/300/95
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Reference materialUpdated frequently asked questions to inform sponsors about discontinuing the pre-market evaluation of HCNs.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q3B (R2); CPMP/ICH/2738/99
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E1; CPMP/ICH/375/95
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/SWP/1042/99 Rev 1 Corr
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/ICH/1840/01
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Reference materialThe TGA has investigated potential safety issues with complementary medicines with soft gel capsule dosage forms
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/SWP/2592/02 Rev 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/133540/2017
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q1B; CPMP/ICH/279/95
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q1D; CPMP/ICH/4104/00
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q1E; CPMP/ICH/420/02
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - 3AB1a