We’re experiencing issues with our datasets and search. We apologise for any inconvenience while we work to fix this.
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
Topics
- Shortages and supply disruptions (23)
- Safety monitoring and information (11)
- Manufacturing (7)
- Compliance and enforcement (6)
- Labelling and packaging (4)
- Import and export (3)
- Scheduling (national classification system) (3)
- Committees and advisory bodies (2)
- Legislation (2)
- Advertising (1)
- Clinical trials (1)
- Fees and payments (1)
- Medicinal cannabis hub (1)
- Weight loss products (1)
Collection content
116 result(s) found, displaying 91 to 100
-
User guideThis user guide describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines
-
User guideA user guide on how to change sponsor details in PI and labels.
-
FormsSponsors should note that the Bioequivalence Study Information Form (BSIF) has been amended
-
User guideElectronic data interchange for ICSR submission using the E2B R2 format
-
FormsForms and proformas for CTD Module 1 submissions, including administrative requirements and supporting documentation for lodging applications with the TGA.
-
FormsChecklist to assist in a priority review designation 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.
-
FormsUse these forms to request a meeting and to record agenda items and outcomes.
-
FormsA revised CPD template for Biological medicines and vaccines is now available for sponsors
-
User guideQuestions and answers for drafters/submitters