The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Prescription medicines collection
This collection provides a list of content related to prescription medicines.
Loading...
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
- Prescription medicines (75)
- Over the counter (OTC) medicines (12)
- Manufacturing (7)
- Australian Register of Therapeutic Goods (ARTG) (6)
- Complementary medicines (6)
- Non-prescription medicines (6)
- Regulatory compliance (6)
- Safety (6)
- Shortages (6)
- In Vitro Diagnostic medical devices (IVDs) (4)
- Labelling and packaging (4)
- Therapeutic goods regulation (4)
- Import and export (3)
- Listed medicines (3)
- Scheduling (national classification system) (3)
- Advisory bodies and committees (2)
- Biological medicines (2)
- Legislation (2)
- Medicine safety (2)
- Registered complementary medicines (2)
- Advertising (1)
- Alert/Advisory (1)
- Assessed listed medicines (1)
- Clinical trials (1)
- Electronic submissions (1)
- Fees and payments (1)
- Medicinal cannabis hub (1)
- TGA conformity assessment certification (1)
Collection content
100 result(s) found, displaying 21 to 30
-
GuidanceGuidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines
-
GuidanceGuidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.
-
GuidanceGuidance for sponsors and manufacturers of prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).
-
GuidanceGuidance on providing adventitious agent safety information in applications for medicines containing, or manufactured using, materials of animal or human origin.
-
GuidanceGuidance on provisional registration process for prescription medicines with provisional determination.
-
GuidanceThis guidance explains the administrative and prescribing (dossier) information you need to support the registration of a prescription medicine. It also applies to varying the details of an Australian Register of Therapeutic Goods (ARTG) registration for a prescription medicine.
-
GuidanceAustralian recommendations and requirements
-
GuidanceGuidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.
-
GuidanceGuidance about the types of notifications and variations for biological medicines.
-
GuidanceGuidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.