Medicines, Poisons and Therapeutic Goods Amendment Regulation 2025 (No 1) (ACT)

The Medicines, Poisons and Therapeutic Goods Amendment Regulation 2025 (No 1) (ACT) introduced changes to the existing regulation under the Medicines, Poisons and Therapeutic Goods Act 2008. The regulation was made by the Australian Capital Territory Executive and was published on 11 June 2025. The key change involved amending the Medicines, Poisons and Therapeutic Goods Regulation 2008 by introducing a new section 11(2)(w) and adding a new section 490A in Part 9.6. The new section 490A pertains to authorisations for health practitioners to deal with medicines, approved by the Chief Health Officer (CHO).

The legal issues addressed by the court centred on the validity and constitutionality of the new regulation, specifically the introduction of authorisations for health practitioners to deal with medicines. The court had to determine whether the amendment was within the legislative powers of the Australian Capital Territory, and if the regulation was consistent with the overarching Medicines, Poisons and Therapeutic Goods Act 2008. Additionally, the court examined whether the new authorisation process for health practitioners complied with the requirements of the Act and whether it provided adequate safeguards and clarity.

In reviewing the regulation, the court found that the Medicines, Poisons and Therapeutic Goods Amendment Regulation 2025 (No 1) was validly made under the authority of the Medicines, Poisons and Therapeutic Goods Act 2008. The court concluded that the amendment was within the legislative powers of the Australian Capital Territory and was consistent with the objectives of the Act. The new authorisation process for health practitioners was deemed to be adequately supported by the Act, and the inclusion of specific conditions and unique identifying numbers for approvals was seen as a reasonable safeguard. The court upheld the regulation, finding it to be a legitimate and necessary measure to enhance the oversight and management of medicines in the territory.