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 91 to 100
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User guideSteps to register a new fixed combination medicine.
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Reference materialThis information is intended for sponsors applying to the TGA to enter a radiopharmaceutical in the Australian Register of Therapeutic Goods (ARTG).
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FormsSubmission dossier checklist for prescription medicines
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FormsCertified product details (CPD) - Chemical prescription medicines
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User guideInformation on how to compile a literature based submission (including mixed applications).
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User guideHow to search TGA business services for approved ingredients and accepted TGA terminology.
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Reference materialSearch the Code Tables for codes needed to apply for good manufacturing practice (GMP) clearance.
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PublicationsThese guidelines apply to company-sponsored post-marketing surveillance studies of drug safety and toxicity
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PublicationsTGA approach to disclosure of commercially confidential information (CCI)
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CommitteeInformation on the role and membership of ACM and proposed meeting dates.