,1 min read
For pharmaceutical companies operating in or exporting to Australia, regulatory compliance doesn’t end at approval—it extends to ensuring product authenticity across the entire supply chain. In a recent alert, the Therapeutic Goods Administration (TGA) issued strong warnings regarding the growing presence of counterfeit medicines entering the Australian market, posing serious risks to patient safety and brand credibility.
The TGA’s concern is not isolated. The rise in unapproved online sales, unauthorized imports, and diverted distribution channels has made it critical for sponsors to implement strict anti-counterfeiting measures. These include tamper-proof packaging, serialisation, track-and-trace systems, and proactive pharmacovigilance protocols.
Importantly, under Australian law, the sponsor or MAH (Marketing Authorisation Holder) is responsible for ensuring that only legitimate, approved products reach patients. Even unintentional breaches due to third-party distributors can result in regulatory action, fines, product recalls, or reputational damage.
At Freyr, we help clients establish robust anti-counterfeiting frameworks, aligned with TGA expectations. From supply chain mapping and verification systems to label compliance, post-market surveillance, and recall readiness—we ensure your product is protected and compliant from manufacturing to patient delivery.
With increased scrutiny from TGA, a proactive approach is no longer optional—it's essential for regulatory success in Australia.