What this instrument does
The federal government has registered a new legislative instrument called the Therapeutic Goods (Information Specification - Annual Charge Exemption Scheme) Instrument 2026. It was registered on 23 September 2026 and is administered by the Department of Health, Disability and Ageing.
The instrument sets out what therapeutic goods information can be released publicly in connection with the annual charge exemption scheme.
What it replaces
The instrument formally repeals the earlier Therapeutic Goods Information (Exemptions from Annual Charges) Specification 2016. That earlier specification no longer has effect.
What the instrument does not specify
The source document does not set out:
- which businesses or goods qualify for the annual charge exemption
- what the exemption amounts are
- what steps a business must take to access the exemption
Key actions
- Businesses that register therapeutic goods with the TGA and currently claim or plan to claim an annual charge exemption can read the full instrument at https://www.legislation.gov.au/F2026L01279 to check whether the new rules change eligibility or obligations compared to the 2016 specification it replaces.
- Businesses that relied on the Therapeutic Goods Information (Exemptions from Annual Charges) Specification 2016 can confirm their current arrangements still comply under the 2026 instrument, as the 2016 specification has been formally repealed.
- The Department of Health, Disability and Ageing can be contacted for guidance on how the new instrument affects TGA annual charge exemption arrangements. The source does not provide a direct contact number or email address.
This is a plain-English summary for information only, not legal or compliance advice. Always check the official source or consult a qualified professional.