Regulatory decisions & notices
The Secretary can, under the Therapeutic Goods Act 1989 and under the Therapeutic Goods Regulations 1990, make decisions in relation to individual sponsors, manufacturers and advertisers. Some of those decisions are made in the event of non compliance with regulatory requirements and some are made at the request of the sponsor or manufacturer.
Records of decisions
- Failure to pay annual charges
The Secretary can cancel the entry of therapeutic goods in the ARTG if the sponsor has failed to pay the annual charge for the goods within 28 days (or 20 working days in the case of medical devices) after it becomes payable
- Failure to pay annual charges - manufacturing licences revoked
If a sponsor fails to pay the annual licence charge or prescribed inspection fees, the Secretary can revoke the manufacturing licence.
- Cancellations requested by the sponsor
The Secretary can cancel the entry of therapeutic goods in the ARTG at the request of the sponsor
- Cancellations requested by the sponsor of certain devices within an entry
The Secretary can cancel some of the devices covered by an ARTG entry
- Consent to import, supply or export goods that do not comply with standards
This database provides information about the therapeutic goods that the TGA has given consent to import, supply, or export therapeutic goods that are not compliant with standards