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The Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024 (the Amendment Regulations) was approved by the Governor-General at the Federal Executive Council meeting on 12 December 2024 and was registered on the Federal Register of Legislation on 13 December 2024.
The Amendment Regulations amend the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 to:
- clarify the circumstances in which certain therapeutic vaping goods are exempt—under the ‘notified vaping goods exemptions’—from inclusion in the Australian Register of Therapeutic Goods. This will better enable the Therapeutic Goods Administration (TGA) to regulate such goods within the lawful supply chain, including by removing goods that do not comply with the regulatory requirements, and providing greater clarity to industry participants about the circumstances in which such goods are exempt;
- support the safety, quality and performance of notified vaping goods by updating existing conditions to clarify that notified vaping goods must comply with current versions of the applicable product standards, as updated and in force from time;
- support the TGA in monitoring the lawful supply of notified vaping goods by enabling the Secretary to require a sponsor to provide information in a specified form about the supply of notified vaping goods; and
- make other minor or ancillary amendments and corrections.
Commencement
The Amendment Regulations commenced on 14 December 2024.