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 (72)
- Over the counter (OTC) medicines (12)
- Safety (8)
- Australian Register of Therapeutic Goods (ARTG) (7)
- Manufacturing (7)
- Complementary medicines (6)
- Non-prescription medicines (6)
- Regulatory compliance (6)
- 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)
- Shortages (3)
- Advisory bodies and committees (2)
- Electronic submissions (2)
- Legislation (2)
- Registered complementary medicines (2)
- Alert/Advisory (1)
- Assessed listed medicines (1)
- Biological medicines (1)
- Clinical trials (1)
- Fees and payments (1)
- Medical devices safety (1)
- Medicinal cannabis hub (1)
- TGA conformity assessment certification (1)
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Collection content
98 result(s) found, displaying 51 to 60
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Reference materialInformation about what to include in the PI and CMI for products included in the Black Triangle Scheme.
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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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Reference materialFind 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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Reference materialImportant information on the Database of TGA Laboratory testing results.
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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 materialIf sponsorship is transferred to you, you need to notify the TGA