We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | OTC Medicines Regulatory Guidance | November 2015 |
| V1.1 | Update to steps 2, 8 and 9 of the process to reflect the new OTC fee structure commencing on 1 January 2016. | COMB - OTC Medicines Evaluation Section | December 2015 |
| V1.2 | Update to steps to reflect the new notification process commencing 1 July 2017. | OTC Medicines Evaluation Section / Scientific Operations Management Section | June 2017 |
| V1.3 | Update step 13 of the process to include information on publishing PI/CMIs on the TGA website | Complementary and OTC Medicines Branch | August 2020 |