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Priority review Rule Amended Final

National Health (Minimum Stockholding) Amendment Determination (No. 3) 2026

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Published March 26th, 2026
Detected March 26th, 2026
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Summary

The Australian Department of Health has issued the National Health (Minimum Stockholding) Amendment Determination (No. 3) 2026. This amendment revises the minimum stockholding requirements for pharmaceuticals, with changes taking effect on April 1, 2026, and October 1, 2026.

What changed

The National Health (Minimum Stockholding) Amendment Determination (No. 3) 2026, issued by the Australian Department of Health, amends the National Health (Minimum Stockholding) Determination 2023. This legislative instrument revises the minimum stockholding requirements for pharmaceuticals, impacting the supply chain and availability of medicines. The amendments are scheduled to take effect in two phases: April 1, 2026, and October 1, 2026.

Pharmaceutical manufacturers and distributors must review and comply with the updated stockholding obligations. Failure to adhere to these revised requirements could lead to penalties under the National Health Act 1953. Compliance officers should ensure their inventory management systems and supply chain strategies align with the new deadlines and stockholding levels to avoid regulatory action.

What to do next

  1. Review updated minimum stockholding requirements for pharmaceuticals
  2. Adjust inventory management and supply chain strategies to meet new requirements
  3. Ensure compliance with stockholding levels by April 1, 2026, and October 1, 2026

Source document (simplified)

- Interactions

National Health (Minimum Stockholding) Amendment Determination (No. 3) 2026

In force Administered by
- Department of Health, Disability and Ageing
This item is authorised by the following title:


View document Legislative instrument Explanatory statement Filter active Table of contents
- 1 Name
- 2 Commencement
- 3 Authority
- 4 Schedules
- Schedule 1—Amendments commencing 1 April 2026
- National Health (Minimum Stockholding) Determination 2023
- Schedule 2—Amendments commencing 1 October 2026
- National Health (Minimum Stockholding) Determination 2023

Named provisions

Name Commencement Authority Schedules

Classification

Agency
GP
Published
March 26th, 2026
Instrument
Rule
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
F2026L00379
Supersedes
National Health (Minimum Stockholding) Determination 2023

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Pharmaceutical Stockholding
Geographic scope
Australia AU

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Pharmaceuticals Public Health

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