Prescription medicines collection
Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
This collection provides a list of content relevant to the regulation of prescription medicines. It assists sponsors registering a new, or varying an existing, prescription medicine ARTG entry in Australia.
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Topics
- Prescription medicines (74)
- Over the counter (OTC) medicines (12)
- Manufacturing (7)
- Safety (7)
- Australian Register of Therapeutic Goods (ARTG) (6)
- Complementary medicines (6)
- Non-prescription medicines (6)
- Regulatory compliance (6)
- Shortages (5)
- Therapeutic goods regulation (5)
- In Vitro Diagnostic medical devices (IVDs) (4)
- Labelling and packaging (4)
- Import and export (3)
- Listed medicines (3)
- Medicines safety (3)
- Scheduling (national classification system) (3)
- Advisory bodies and committees (2)
- Alert/Advisory (2)
- Biological medicines (2)
- Legislation (2)
- Registered complementary medicines (2)
- Assessed listed medicines (1)
- Clinical trials (1)
- Electronic submissions (1)
- Fees and payments (1)
- Medical devices safety (1)
- Medicinal cannabis hub (1)
- TGA conformity assessment certification (1)
Results for
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Collection content
100 result(s) found, displaying 1 to 10
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DatasetFind information about adverse events related to medicines, vaccines and biological therapies used in Australia.
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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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PageImportant information on the Database of TGA Laboratory testing results.
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PageFind out about the discontinuation of Protaphane InnoLet insulin cartridges and the substitute product available.
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PageThis information explains your responsibilities when obtaining Good Manufacturing Practice (GMP) clearance by any pathway, or by GMP certification following our inspection.
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PageFind out about obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site.
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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.