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 31 to 40
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GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.
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GuidanceGuidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.
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GuidanceGuidance about application pathways and data requirements for new generic medicines, and variations to existing medicines.
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GuidanceGuidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).
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GuidanceGuidance for sponsors about how to apply for orphan drug designation for a prescription medicine.
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GuidanceGuidance on submitting the CPD for prescription medicines.
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GuidanceGuidance on specific criteria and paperwork required for submission to the TGA to ensure conformance with TGO 93.
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GuidanceGuidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.
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GuidanceGuidance on applying for a provisional determination, which is the first step of the provisional approval pathway.
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GuidanceGuidance on how to request early scientific advice on a biowaiver justification.