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 (8)
- Advertising (5)
- 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
638 result(s) found, displaying 26 to 50
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/QWP/BWP/259165/2019
-
User guideA step-by-step guide to completing the form
-
User guideThis document applies to all regulatory activities in electronic Common Technical Document (eCTD) format.
-
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.
-
Compositional guidelinesCompositional guideline for Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate permitted for use in listed medicines.
-
User guideHow to view and respond to notifications related to an application for consent to import, supply, or export medical devices that do not meet the Essential Principles.
-
ChecklistsThese checklists summarise key obligations for psychiatrists applying to prescribe and access MDMA and psilocybine under the Authorised Prescriber scheme.
-
User guideThis user guide is for sponsors wanting to submit GMP clearance application by the TGA Business services (TBS) portal.
-
FormsThis form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.
-
FormsUpdated form used to notify us of proprietary ingredient mixtures for use in therapeutic goods.
-
User guideHow to successfully complete and submit an application for consent to import, supply, or export medical devices that do not meet the Essential Principles.
-
ChecklistsThis checklist can help you assess if your advertising complies with legislative requirements.
-
User guideApply for our approval to use a restricted representation in advertising.
-
User guideInformation on how to compile a literature based submission (including mixed applications).
-
FormsTemplates to help you with your communications under the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).
-
FormsThis form is used to nominate a new representative from your organisation to be the administrator
-
Compositional guidelinesCompositional guideline for 'Steviol glycosides' permitted for use in listed medicines
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/QWP/1401/98 Rev. 1/Corr **
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CPMP/4548/03/Final/Rev 1
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E3 Q&As (R1); EMA/CHMP/ICH/435606/2012
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/BWP/477/97
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/VWP/457259/2014
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/303353/2010.
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/189724/2018
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/40072/2010 Rev. 1.