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What’s changed?
In 2025, the Therapeutic Goods (Exempt Monographs) Amendment Determination was introduced under the Therapeutic Goods Act 1989 (the Act). This amendment updates the 2021 determination to exempt specific labelling requirements in certain pharmacopoeial monographs.
Who does this affect?
This change applies to listed medicines (excluding export-only products) that contain certain whole live microorganisms as active ingredients—commonly known as probiotic medicines.
What’s the exemption?
There is a requirement in monograph 3053 for Live Biotherapeutic Products for Human Use of both the British Pharmacopoeia (BP) and European Pharmacopoeia (EP) that states:
The label must include the name of any stabilisers and other excipients.
This requirement no longer applies to eligible listed medicines in Australia.
This exemption means that the specified labelling statement is not considered part of the default standards under the Act. As a result, sponsors of affected products are not required to include this information on their labels to meet monograph 3053.