We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
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.
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
Topics
- Prescription medicines (74)
- Over the counter (OTC) medicines (12)
- Safety (8)
- Manufacturing (7)
- Australian Register of Therapeutic Goods (ARTG) (6)
- Complementary medicines (6)
- Non-prescription medicines (6)
- Regulatory compliance (6)
- Shortages (5)
- 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)
- Advisory bodies and committees (2)
- Alert/Advisory (2)
- Legislation (2)
- Registered complementary medicines (2)
- Assessed listed medicines (1)
- Biological medicines (1)
- Clinical trials (1)
- Electronic submissions (1)
- Fees and payments (1)
- Medical devices safety (1)
- Medicinal cannabis hub (1)
- TGA conformity assessment certification (1)
Results for
"[search-keyword]"
Collection content
99 result(s) found, displaying 1 to 10
-
GuidanceGuidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92
-
Medicine shortage alertsPharmacists can use a Serious Scarcity Substitution Instrument (SSSI) to dispense Protaphane Penfill human insulin in the place of a Protaphane InnoLet cartridge.
-
GuidanceGuidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.
-
GuidanceGuidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.
-
GuidanceGuidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.
-
GuidanceGuidance on submitting an effective prescription medicines application.
-
GuidanceGuidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceGuidance on when and how to provide Product Information to us.
-
GuidanceGuidance on bioavailability and/or bioequivalence aspects of prescription medicines including information on biowaivers.
-
GuidanceThis guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).