Resources
Search our resources for user guides, checklists, international scientific guidelines, compositional guidelines and forms.
Can't find what you’re looking for? You can also:
- search our Publications
- use the site search bar in the top right of this screen for more results.
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
Topic
- Safety monitoring and information (51)
- Clinical trials (44)
- Legislation (23)
- Manufacturing (23)
- Import and export (10)
- Compliance and enforcement (7)
- Advertising (4)
- Labelling and packaging (4)
- Medicinal cannabis hub (4)
- Shortages and supply disruptions (3)
- Vaping hub (3)
- Committees and advisory bodies (2)
- Fees and payments (2)
- Scheduling (national classification system) (2)
- Unique Device Identification (UDI) hub (1)
Search
630 result(s) found, displaying 76 to 100
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/457920/2012 rev 1
-
FormsUse this form to request reinstatement of a cancelled entry on the Australian Register of Therapeutic Goods.
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/247713/2012
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/311805/2014.
-
FormsThe application form to amend the current Poisons Standard.
-
FormsUpdated form used to notify us of proprietary ingredient mixtures for use in therapeutic goods.
-
FormsUse this form to apply for an Australian Approved Name (AAN).
-
FormsForm to notify the TGA of the Exceptional Release of a non-conforming biological.
-
User guideThis user guide outlines how to communicate effectively with consumers using the revised Consumer Medicine Information (CMI) template
-
-
International scientific guidelines adopted in AustraliaInternational scientific guideline - (CPMP/QWP/2819/00) EMEA/CVMP/814/00
-
FormsApply to import and supply substitute medicines under section 19A
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/488220/2012.
-
FormsRequest cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG).
-
User guideStep by step user guide on submitting applications to register a complementary medicine or over the counter (OTC) medicine in the Australian Register of Therapeutic Goods, using the TGA Business services.
-
ChecklistsThis checklist can help you assess if your advertising complies with legislative requirements.
-
FormsSubmission dossier checklist for prescription medicines
-
International scientific guidelines adopted in AustraliaInternational Scientific Guideline - (CPMP/QWP/2820/00) EMEA/CVMP/815/00
-
FormsComplete this form to authorise or remove an agent (e.g. a regulatory affairs consultant) or people external to your company to undertake regulatory correspondence with us.
-
FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N2 application
-
User guideElectronic data interchange for ICSR submission using the E2B R2 format
-
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.
-
User guideThis user guide will assist you in providing the required information for completing (and submitting) an application for an assessed listed medicine (either for new ARTG entries or changes to existing ARTG entries)
-
FormsThis form is used to nominate a new representative from your organisation to be the administrator
-
FormsApply for a Certificate of Free Sale or an Export Certificate for a medical device.