TGA Sponsor-Requested Cancellations of Therapeutic Goods: Regulatory Process and Actions

1. Overview

The Therapeutic Goods Administration (TGA) processes cancellations of therapeutic goods from the Australian Register of Therapeutic Goods (ARTG) when requested by the sponsor under the Therapeutic Goods Act 1989. These are distinct from TGA-initiated cancellations. Published information covers decisions on cancellations, revocations, and reviews. Once cancelled, the sponsor cannot import, export manufacture, or export the goods unless exempt or otherwise approved. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/cancellations/information-about-cancellations-requested-sponsor-regulatory-actions

2. Effects of Cancellation

Effective cancellation prohibits the sponsor from importing into, manufacturing in, or exporting from Australia the cancelled goods, except where exemptions or approvals apply under the Act. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/cancellations/information-about-cancellations-requested-sponsor-regulatory-actions

3. Revocation of Cancellation

Within 90 days of the cancellation taking effect, the sponsor may request revocation under:

• Section 30A (for listed and registered therapeutic goods)
• Section 32GD (for biologicals)
• Section 41GLA (for medical devices)

Particulars of revocation decisions are published in the database under 'Decision status'. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/cancellations/information-about-cancellations-requested-sponsor-regulatory-actions

4. Review Options

A person whose interests are affected by the cancellation may request review by a delegate of the Minister for Health under section 60 of the Act within 90 days. Further review may be sought from the Administrative Review Tribunal (ART). Decisions revoking cancellations (by sponsor request or Minister's delegate) are published in the database under 'Decision status'. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/cancellations/information-about-cancellations-requested-sponsor-regulatory-actions

5. Publication and Database

The database contains records of regulatory decisions required under the Act, including initial cancellations and any revocations. Records remain available even if the goods are reinstated. To confirm current authorisation, check the ARTG directly. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/cancellations/information-about-cancellations-requested-sponsor-regulatory-actions

6. Affected Product Types

Cancellations may apply to biologicals, faecal microbiota transplant products, human cell and tissue products, medical devices, medicines, unapproved therapeutic goods, and medicinal cannabis. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/cancellations/information-about-cancellations-requested-sponsor-regulatory-actions

7. Additional Notes

Last updated: 17 October 2024. This information focuses on sponsor-requested cancellations as regulatory actions. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/cancellations/information-about-cancellations-requested-sponsor-regulatory-actions