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 61 to 70
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Reference materialGuidance on how to change sponsor details in PI and labels
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FormsSponsors should note that the Bioequivalence Study Information Form (BSIF) has been amended
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Reference materialIf an ingredient name is not on the approved list, you can submit a proposal for it to be included
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Reference materialGuidance for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines
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User guideElectronic data interchange for ICSR submission using the E2B R2 format
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Reference materialGuidance on how the Poisons Standard is amended and details of the processes that underpin the scheduling policy
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Reference materialRisk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form
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Reference materialGuidance on colourings in medicines for topical and oral use
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FormsChecklist to assist in a priority review designation application