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 21 to 30
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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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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 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 about the types of notifications and variations for chemically derived (non-biological) prescription medicines.
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GuidanceGuidance on bioavailability and/or bioequivalence aspects of prescription medicines including information on biowaivers.
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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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Applying for new over-the-counter inhalation or nasal spray medicines or changing existing medicines
GuidanceGuidance about application pathways and data requirements for new generic medicines, and variations to existing medicines. -
GuidanceGuidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries 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.