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
636 result(s) found, displaying 1 to 25
-
FormsThis form collects information about the legal entity making applications under the Therapeutic Goods Act 1989.
-
FormsForms for notifying the TGA of a change in sponsorship.
-
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.
-
FormsWe are redeveloping the Conformity Assessment application form to enable applicants to provide all the required information at the time of submitting their application.
-
FormsRequest cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG).
-
FormsThis form is used to nominate a new representative from your organisation to be the administrator
-
-
FormsThis form is to be completed by the ingredient owner to authorise sponsors to use a protected ingredient that is the subject of an exclusivity period to list a medicine in the Register
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/239/95 final
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/239/95 Rev. 1, Corr.1*
-
User guideUpdated information for registered users of the Australian Adverse Drug Reaction Reporting System
-
User guideHow to use the ADR reporting template in the Best Practice software
-
User guideHow to install the ADR reporting template in the Best Practice software.
-
FormsSuspected adverse events that occur after having a vaccination can be reported to the TGA
-
FormsUse this form to report suspected adverse reactions to vaccines and prescription, over the counter and complementary medicines.
-
User guideUsing the ADR reporting template in the Medical Director software
-
User guideInstalling the ADR reporting template in the Medical Director software.
-
FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N2 application
-
FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N1 application
-
ChecklistsThis checklist assists sponsors to prepare a change application at the C1 level for a registered OTC medicine.
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH E6(R3) Guideline for Good Clinical Practice
-
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH E6 (R2) Integrated Addendum
-
FormsThe application form to amend the current Poisons Standard.
-
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.
-
FormsThis form allows sponsors of notified therapeutic vaping goods, which includes therapeutic vaping kits, to provide information to the TGA about the supply of those goods during a specified period, upon formal request by the Secretary or their delegate.