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 71 to 80
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Reference materialActive ingredient names section updated, following publication of Nomenclature of biological medicines consultation
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User guideThis is a step-by-step guide for agents and sponsors who wish to apply for Priority review, Provisional determination or Orphan drug designation of a prescription medicine.
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Reference materialThe Scheduling Policy Framework (Scheduling Policy) sets out the national policy for applying access restrictions on medicines and chemicals.
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Reference materialThe NeeS specification is an interim arrangement as applicants plan the move to full eCTD
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Reference materialUpdate to the six clinical evaluation streams and the functions each unit provides
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Reference materialA new version of the code of practice for tamper-evident packaging of therapeutic goods is now available
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Reference materialUpdate to Stability testing of prescription medicines
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FormsA revised CPD template for Biological medicines and vaccines is now available for sponsors