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30 result(s) found, displaying 1 to 25
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FormsPrescription medicines Minor Variation E-form now available
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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 - EMEA/CHMP/CVMP/QWP/17760/2009 Rev2
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User guideThis user guide is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device.
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FormsThe Registered medicine variation form (complementary medicines) should only be used when you wish to vary the particulars of complementary medicines which are already registered in the ARTG.
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FormsUse this form for Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines applications, or variations.
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User guideA user guide on how to change sponsor details in PI and labels.
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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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User guideThis user guide describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines
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FormsUse this form to request reinstatement of a cancelled entry on the Australian Register of Therapeutic Goods
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FormsSponsors can use this form to apply for an additional trade name for a registered prescription medicine, under section 23 of the Therapeutic Goods Act 1989.
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User guideThis user guide is for sponsors applying to change the entry in the ARTG for a registered non-prescription OTC medicine.
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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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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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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/310834/2012 Rev. 1
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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 scheduling changes.
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User guideThis document applies to all regulatory activities in electronic Common Technical Document (eCTD) format.
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User guideThis form is used to include a new biological or vary an existing biological on the ARTG
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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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FormsRequest cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG)
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/PRAC/222346/2014
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User guideHow to withdraw your ARTG application, for medical device sponsors (includes importers and exporters).
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FormsInformation on when a manufacturer's statutory declaration is required.
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User guideInstructions for applicants on how to organise and fill out a pre-submission planning form (PPF).
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User guideThe system now allows equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the ARTG