From 5 November 2026, the Poisons and Therapeutic Goods Act 1966 and Poisons and Therapeutic Goods Regulation 2008 will be replaced respectively by the:
The requirements on this page 5 November 2026 onwards.
For requirements before 5 November 2026, see Application for Authority to Prescribe Certain Restricted Substances.
A nominated Schedule 4 medicine is a prescription-only medicine that has additional restrictions due to the potential significant risks associated with its use.
Nominated Schedule 4 medicines include retinoids (such as acitretin or oral isotretinoin), ovulatory stimulants (such as clomiphene), prostaglandins (such as dinoprost), plus thalidomide and lenalidomide. A full list is available in the table below.
Treatment with these medicines should only be initiated by a medical practitioner with the appropriate qualifications and expertise. A list of the medicines and the relevant practitioner qualifications is provided in the table below.
All other prescribers such as those continuing treatment under a relevant specialist will require approval from NSW Health.
Some exemptions apply as listed below.
Approval from NSW Health is not required under the following circumstances:
1. You are a prescriber with the above specialty prescribing, supplying, or administering the listed medicine under your specialty.
2. You are covering another practitioner temporarily
When prescribing, supplying or administering medicines on behalf of another practitioner who holds approval and is temporarily unavailable, and you:
3. You are treating patients in hospital
When treating a patient who is admitted to, or receiving emergency treatment in, a public or private hospital.
4. You are continuing treatment in correctional centres
When treating a person who enters custody in a correctional centre and requires continuation of treatment with a medicine they were receiving immediately prior to entering custody.
5. You are a veterinary practitioner treating an animal.
Applications for approval to prescribe, supply, or administer nominated Schedule 4 medicines will be available in late 2026.
If you require an approval before 5 November 2026, refer to Application for Authority to Prescribe Certain Restricted Substances.
More information is available in the relevant section of the Medicines, Poisons and Therapeutic Goods Act 2022and the Medicines, Poisons and Therapeutic Goods Regulation 2026.
The information on this webpage is provided for general guidance only. While reasonable care has been taken to ensure the accuracy, reliability, and currency of the information, users should refer to the Medicines, Poisons and Therapeutic Goods Act 2022 and the Medicines, Poisons and Therapeutic Goods Regulation 2026 for full and current legal requirements.
