We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
Topics
- Shortages and supply disruptions (21)
- Safety monitoring and information (13)
- Manufacturing (7)
- Compliance and enforcement (6)
- Labelling and packaging (4)
- Import and export (3)
- Scheduling (national classification system) (3)
- Committees and advisory bodies (2)
- Legislation (2)
- Advertising (1)
- Clinical trials (1)
- Fees and payments (1)
- Medicinal cannabis hub (1)
Collection content
113 result(s) found, displaying 21 to 30
-
GuidanceGuidance on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.
-
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.
-
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.