Prescription medicines collection
Formerly the 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 (75)
- Over the counter (OTC) medicines (13)
- Complementary medicines (7)
- Non-prescription medicines (7)
- Manufacturing (6)
- Regulatory compliance (6)
- Safety (6)
- Therapeutic goods regulation (6)
- In Vitro Diagnostic medical devices (IVDs) (5)
- Australian Register of Therapeutic Goods (ARTG) (4)
- Listed medicines (4)
- Shortages (4)
- Advisory bodies and committees (3)
- Import and export (3)
- Labelling and packaging (3)
- Medicines safety (3)
- Scheduling (national classification system) (3)
- Assessed listed medicines (2)
- Electronic submissions (2)
- Legislation (2)
- Alert/Advisory (1)
- Clinical trials (1)
- Medical devices safety (1)
- Medicinal cannabis hub (1)
- Registered complementary medicines (1)
- TGA conformity assessment certification (1)
Results for
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Collection content
103 result(s) found, displaying 1 to 10
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Reference materialThis page is for industry stakeholders (e.g. manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA
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GuidanceGuidance on the regulatory requirements for therapeutic goods that contain, or are produced from, human blood or plasma
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GuidanceGuidance on how to request early scientific advice on a biowaiver justification.
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GuidanceGuidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
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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 for sponsors about how to apply for orphan drug designation for a prescription medicine.
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GuidanceGuidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).
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GuidanceGuidance on how we make use of assessments from comparable overseas regulators (CORs).
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GuidanceGuidance for sponsors of antibiotics on collecting and providing pre- and post-market information about antibiotic resistance.
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