The Therapeutic Goods Administration (TGA) has issued an infringement notice, to the value of $19,800, to Cellife Health Care Pty Ltd (Cellife) for the alleged supply of a listed medicine that did not comply with an applicable standard, in contravention of the Therapeutic Goods Act 1989 (the Act).
Cellife paid the infringement notice in July 2026.
The alleged non-compliance relates to the supply of a medicine without the required child-resistant packaging, where the level of iron in the medicine exceeded the threshold at which child-resistant packaging is required.
Child-resistant packaging is an important safety control designed to reduce the risk of accidental poisoning, particularly in children. The absence of this safeguard increases the risk of serious harm, particularly for medicines containing higher levels of iron.
The therapeutic goods regulatory framework requires sponsors to ensure that all medicines supplied in Australia comply with applicable standards. Failure to comply with these standards undermines key safety protections and may expose consumers to avoidable risk.
The TGA will continue to take action where non-compliance with the Act is identified in accordance with our regulatory compliance framework. This may include cancellation from the ARTG, infringement notices, or civil or criminal proceedings.
If you suspect non-compliance in relation to therapeutic goods, you can report it to the TGA at any time.
