The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Prescription medicines collection
This collection provides a list of content related to prescription medicines.
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- Prescription medicines (75)
- Over the counter (OTC) medicines (12)
- Manufacturing (7)
- Australian Register of Therapeutic Goods (ARTG) (6)
- Complementary medicines (6)
- Non-prescription medicines (6)
- Regulatory compliance (6)
- Safety (6)
- Shortages (6)
- In Vitro Diagnostic medical devices (IVDs) (4)
- Labelling and packaging (4)
- Therapeutic goods regulation (4)
- Import and export (3)
- Listed medicines (3)
- Scheduling (national classification system) (3)
- Advisory bodies and committees (2)
- Biological medicines (2)
- Legislation (2)
- Medicine safety (2)
- Registered complementary medicines (2)
- Advertising (1)
- Alert/Advisory (1)
- Assessed listed medicines (1)
- Clinical trials (1)
- Electronic submissions (1)
- Fees and payments (1)
- Medicinal cannabis hub (1)
- TGA conformity assessment certification (1)
Collection content
100 result(s) found, displaying 61 to 70
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Medicine shortage alertsPharmacists can use a Serious Scarcity Substitution Instrument (SSSI) to dispense Protaphane Penfill human insulin in the place of a Protaphane InnoLet cartridge.
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FormsFind out how the free trade agreement affects your application to include a product on the Australian Register of Therapeutic Goods.
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User guideFind out when you should use a literature-based submissions (LBS) for your application.
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User guideUser guide on how to submit shortage/discontinuation notifications to the TGA
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FormsApplication form to import, supply or export a therapeutic good that does not comply with standards.
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Reference materialGuidance now includes advice on lodgement of provisional variation applications
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Reference materialGuidance for applicants on how to request and prepare for pre-submission meetings.
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User guideThis user guide describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines
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Reference materialGuidance on how to change sponsor details in PI and labels
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FormsSponsors should note that the Bioequivalence Study Information Form (BSIF) has been amended