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 91 to 98
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Reference materialApplications for extension of indications to align with a reference product can be submitted via the Variation e-form. This electronic form is available through the TBS portal.
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Reference materialThe purpose of this guidance is to assist applicants compile a literature based submission (including mixed applications), and replaces the previous TGA guidance: Literature-Based Submissions - Points to consider (2003).
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User guideHow to search TGA business services for approved ingredients and accepted TGA terminology.
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Reference materialSearch the Code Tables for codes needed to apply for good manufacturing practice (GMP) clearance.
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PublicationsThese guidelines apply to company-sponsored post-marketing surveillance studies of drug safety and toxicity
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PublicationsTGA approach to disclosure of commercially confidential information (CCI)
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CommitteeInformation on the role and membership of ACM and proposed meeting dates.