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 11 to 20
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PageGLP-1 receptor agonists such as Ozempic (semaglutide) and its derivatives are regulated as prescription-only medicines.
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GuidanceGuidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.
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GuidanceGuidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.
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GuidanceGuidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.
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GuidanceGuidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.
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GuidanceGuidance on submitting an effective prescription medicines application.
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GuidanceGuidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance on when and how to provide Product Information to us.
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GuidanceGuidance on bioavailability and/or bioequivalence aspects of prescription medicines including information on biowaivers.
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GuidanceThis guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).