Resources
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- Prescription medicines (12)
- Listed medicines (8)
- Complementary medicines (5)
- Biological medicines (3)
- Manufacturing (2)
- Over the counter (OTC) medicines (2)
- Regulatory compliance (2)
- Assessed listed medicines (1)
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16 result(s) found, displaying 1 to 16
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/CVMP/QWP/17760/2009 Rev2
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/441071/2011 Rev. 2
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1
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Reference materialExplanatory guide on the quality modules to be submitted for influenza vaccine registration, for manufacturers and sponsors.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/63699/2014.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/310834/2012 Rev. 1
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FormsFind out what process to follow if a product is manufactured using a human embryo or a human embryonic stem cell, or any material sourced from such an embryo or stem cell.
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Reference materialGuidance for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/VWP/457259/2014
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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 - EMA/PRAC/222346/2014
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FormsInformation on when a manufacturer's statutory declaration is required.
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User guideFinished product (medicine) analytical procedure validations for complementary medicines.
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Reference materialOverview of stability testing of Listed complementary medicines
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User guideInformation on quality for the medicine/finished product
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User guideUser guide for sponsors that provides the pilot specification and guidance information relevant for preparation of an electronic Common Technical Document (eCTD) sequence to the TGA.