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January 23, 2026
Approximately 5 minutes
Overview of Supplying Therapeutic Goods in Australia – TGA Requirements
Overview of Supplying Therapeutic Goods in Australia – TGA Requirements
Legal Requirement for Supply
- Therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia.
- Supply includes import, export, manufacture, and distribution.
- Exceptions exist for certain exempt or special access scheme goods.
ARTG Inclusion Pathways
- Registered medicines: Full evaluation of quality, safety, and efficacy.
- Listed medicines: Lower-risk, pre-approved ingredients, limited claims.
- Medical devices & IVDs: Classified by risk (I–IV), conformity assessment evidence required.
- Biologicals: Specific pathways for tissues, blood products, and advanced therapies.
Sponsor Responsibilities
- Maintain accurate ARTG entry details.
- Ensure goods meet Essential Principles (devices) or applicable standards (medicines/biologicals).
- Implement appropriate conformity assessment procedures.
- Manage labelling, packaging, and instructions for use.
- Comply with advertising rules (no misleading claims).
- Report adverse events, incidents, and recalls promptly.
- Conduct post-market surveillance and vigilance.
Key Compliance Areas
- Labelling & Packaging:
- Include sponsor details, ARTG number, batch/lot, expiry.
- Use English; meet readability requirements.
- Advertising:
- Restricted for prescription-only and certain devices.
- Must be truthful, balanced, and substantiated.
- Post-Market Obligations:
- Adverse event/incident reporting.
- Field safety corrective actions/recalls.
- Ongoing monitoring of performance/safety.
Special Supply Mechanisms
- Special Access Scheme (SAS): For unapproved goods in limited clinical circumstances.
- Authorised Prescriber Scheme: For specific prescribers and patient groups.
- Clinical trials: Supply under CTN or CTA schemes.
- Exemptions: Certain low-risk or custom-made devices.
Detailed requirements for each product type, ARTG application processes, sponsor obligations, labelling standards, advertising rules, reporting systems, and special access provisions are outlined in the TGA overview of supplying therapeutic goods in Australia. Source: Overview of supplying therapeutic goods in Australia - TGA
This framework ensures only safe, quality-assured therapeutic goods reach the Australian market while supporting innovation and access.
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