Canberra, 13 November 2025 — The Therapeutic Goods Administration (TGA), a division of Australia’s Department of Health, Disability and Ageing, has officially approved a new regulatory instrument mandating the use of an online supply information form for all therapeutic vaping goods. This change is part of the broader implementation strategy aimed at tightening control and improving oversight of vaping products within the country.
WHAT HAS BEEN APPROVED?
The newly released instrument titled “Therapeutic Goods (Therapeutic Vaping Goods Supply Information Form) Approval 2025” sets out that all manufacturers and sponsors of therapeutic vaping devices must now use a designated online form to provide supply information to the TGA.
The form, named:
“Supply of therapeutic vaping goods: Response to request for information”
is now the only approved method for submitting supply-related data. It is accessible via the Applications tab within the TGA Business Services portal.
LEGAL AND REGULATORY FRAMEWORK
The authority for this instrument stems from:
- Item 15, Schedule 5A of the Therapeutic Goods Regulations 1990, and
- Item 2.17, Schedule 4, Part 2 of the Therapeutic Goods (Medical Devices) Regulations 2002.
By formalizing the use of an online form, the TGA is reinforcing a shift towards digitized regulatory compliance, emphasizing traceability, efficiency, and accountability in product oversight.
WHY THIS MATTERS FOR MANUFACTURERS
This legislative update marks a critical shift in compliance expectations for companies in the vaping and therapeutic goods sectors. Manufacturers supplying therapeutic vaping goods in Australia will need to:
- Adopt the new online system for all information submissions.
- Integrate the process into internal regulatory and supply chain procedures.
- Ensure staff are trained to use the TGA Business Services portal effectively.
Failure to comply with this mandate could result in regulatory delays or penalties, as the use of outdated or incorrect forms would not meet the conditions set under the Therapeutic Goods Regulations 1990 and Medical Devices Regulations 2002.
IMPLEMENTATION TIMELINE
- Effective Date: The regulation is effective from 13 November 2025, one day after its formal issuance.
CONCULSION
Manufacturers and sponsors are urged to act promptly to avoid disruption in their regulatory obligations and ensure continuity in product supply.
This regulatory move by the TGA underscores Australia’s continued commitment to responsible oversight of vaping products, especially those marketed for therapeutic purposes. Manufacturers who stay ahead of these changes will not only maintain compliance but also build trust in an increasingly scrutinized market.
For official updates and access to the portal, visit the TGA website.