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 (24)
- 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
637 result(s) found, displaying 501 to 525
-
User guideCheck out our user guide to assist sponsors when using the code tables for GMP Clearance applications.
-
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.
-
FormsSponsors should note that the Bioequivalence Study Information Form (BSIF) has been amended
-
FormsThis form guides you through the classification of biologicals and captures sufficient information about your product for us to provide advice
-
User guideThis document will assist applicants completing biowaiver templates for inclusion in an application for a new prescription generic medicine.
-
User guideElectronic data interchange for ICSR submission using the E2B R2 format
-
User guideA user guide for sponsors on how to fill in a device incident report.
-
Compositional guidelinesCompositional guideline for 'Streptococcus salivarius M18' permitted for use in listed medicines
-
Compositional guidelinesCompositional guideline for 'Calcified Lithothamnion species' permitted for use in listed medicines
-
Compositional guidelinesCompositional guideline for 'Resveratrol' permitted for use in listed medicines
-
User guideUser guide on the Adverse Event Management System (AEMS) for health professionals.
-
-
FormsChecklist to assist in a priority review designation application
-
FormsThis checklist is to be used by sponsors to apply for priority review determination
-
Compositional guidelinesCompositional guideline for 'Streptococcus salivarius K12' permitted for use in listed medicines
-
FormsThe Module 1.2.1: Assessed listed medicine general application information form must be completed in conjunction with the Assessed listed medicines application form.
-
FormsThis form must be completed and submitted for all L(A)1 applications in Module 1.5.7 of the application. Completing this form provides the assurances required to accompany a L(A)1 application.
-
User guideThis is a step-by-step guide for agents and sponsors who wish to apply for Priority review, Provisional determination or Orphan drug designation of a prescription medicine.
-
FormsThis checklist is intended to assist applicants to determine if they have provided all the necessary information to allow the TGA to make an informed decision on the determination application.
-
FormsUse these forms to request a meeting and to record agenda items and outcomes.
-
Compositional guidelinesCompositional guideline for 'Larix arabinogalactan' permitted for use in listed medicines
-
Compositional guidelinesCompositional guideline for 'Chicken comb extract' permitted for use in listed medicines
-
Compositional guidelinesCompositional guideline for 'DHA/EPA rich Schizochytrium algal oil' permitted for use in listed medicines
-
FormsTransfers of conformity assessment certificates.
-
User guideThe OTC Dossier Documents Matrix (the 'matrix') provides a summary of which documents are required for each application level (N1, N2, N3, N4, N5, C1, C2, C3 or C4)