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 31 to 40
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GuidanceGuidance on provisional registration process for prescription medicines with provisional determination.
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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 on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines
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GuidanceGuidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).
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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 for sponsors and manufacturers of prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).
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GuidanceGuidance on submitting the CPD for prescription medicines.
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GuidanceGuidance on when and how to provide Product Information to us.
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