TGA & Australian Compliance

TGA-Compliant Pharmaceutical Promotional Materials

Ensure your pharmaceutical promotional content meets TGA Therapeutic Goods Advertising Code (No. 2) 2018, Therapeutic Goods Act 1989, and Medicines Australia Code of Conduct. Streamline ARTG compliance with automated claim extraction and reference validation.

The Challenge of Australian Pharmaceutical Compliance

$26B
Market Size
Australia's pharmaceutical market value
26M
Population
English-speaking market with PBS coverage
$2,500
Per Violation
TGA advertising code breach penalties

Key TGA Regulatory Requirements

  • • Therapeutic Goods Advertising Code (No. 2) 2018
  • • Therapeutic Goods Act 1989 Section 42DL (advertising offences)
  • • Medicines Australia Code of Conduct Edition 19
  • • Australian Register of Therapeutic Goods (ARTG) alignment
  • • Product Information (PI) and Consumer Medicine Information (CMI) consistency
  • • Advertising Pre-vetting System (APVS) requirements for prescription medicines

How PromoPack Ensures TGA Compliance

Automated TGA Advertising Code Compliance

Every promotional material is validated against TGA Advertising Code (No. 2) 2018 requirements, ensuring compliance with Australian advertising standards before APVS submission.

Product Information Alignment

Validates that all claims align with TGA-approved Product Information (PI) documentation.

ARTG Registration Check

Ensures promotional materials only reference ARTG-registered therapeutic goods.

Evidence Substantiation

Links claims to peer-reviewed evidence meeting TGA's substantiation requirements.

Medicines Australia Code

Validates compliance with voluntary Medicines Australia Code of Conduct standards.

PubMed + Australian Clinical Trial Data

Access 36M+ PubMed citations plus Australian and New Zealand clinical trial data to support your promotional claims with evidence meeting TGA substantiation requirements.

Australia/NZ Data Priority

TGA prefers Australian and New Zealand clinical data when available. PromoPack automatically prioritizes local trial data in reference suggestions.

  • ✓ ANZCTR (Australia New Zealand Clinical Trials Registry) integration
  • ✓ Medical Journal of Australia (MJA) priority ranking
  • ✓ PBS (Pharmaceutical Benefits Scheme) evidence alignment

APVS Submission Packages

Generate submission-ready packages for TGA Advertising Pre-vetting System (APVS) review:

  • Claims & References Report: Complete mapping of promotional claims to supporting literature
  • Product Information Alignment: Documentation showing consistency with TGA-approved PI
  • Audit Trail: Complete documentation of review and approval workflow
  • ARTG Compliance: Verification of therapeutic goods registration status

Why Australian Pharma Teams Choose PromoPack

75%
Faster Reviews
Reduce APVS submission prep time from weeks to days
90%
Fewer Violations
Catch compliance issues before TGA submission
100%
Audit Trail
Complete documentation for TGA inspections

Ready to Streamline Your TGA Submissions?

Join Australian pharmaceutical companies using PromoPack to reduce APVS review cycles and ensure TGA compliance.