Repeal of the Therapeutic Products Act 2023: what changed for devices

1. Key takeaways

The Therapeutic Products Act 2023 (2023 No 37) was repealed on 18 December 2024, and its intended commencement on 1 September 2026 never occurred. The repealing statute is the Therapeutic Products Act Repeal Act 2024 (2024 No 55), which received royal assent on 17 December 2024, came into force the following day (18 December 2024) under its s 2, and repealed the TPA with a single provision in s 3: *“The Therapeutic Products Act 2023 (2023 No 37) is repealed.”*

Material stating “the TPA will commence on 1 September 2026” is out of date. GRZAN verified the official text on legislation.govt.nz: the TPA 2023 never entered into force and was repealed about 21 months before its intended commencement date.

The repealing statute’s structure is unusual: s 10 repeals the Act itself at the end of the 28th day after commencement. It is a self-consuming law — having completed its task it no longer exists on legislation.govt.nz as current legislation. A company searching current law for “which section repealed the TPA” will find nothing.

For device manufacturers the direct meaning is: the current regime is unchanged. Devices remain regulated under the Medicines Act 1981 (1981 No 118) and the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325); there is no pre-supply approval requirement; and the Sponsor (New Zealand sponsor) must complete WAND notification within 30 working days of becoming a Sponsor.

2. Legal basis

The tables below list the instruments and the complete official timeline.

Complete timeline (official dates):

3. Expert insights

Insight 1: the repeal Act disappears after completing its task. Section 10 repeals the Act itself at the end of the 28th day after commencement, 14 January 2025. Self-repeal clauses are uncommon in primary statutes and create a verification difficulty: legislation.govt.nz shows the TPA 2023 as repealed, but the Act that repealed it no longer appears among current law. GRZAN pins citations to the official number 2024 No 55 and the Bill number 67—1, never relying on the current-law search path.

Insight 2: the repeal Act did not just delete — it made consequential repairs. Beyond the core repeal in s 3, s 5 and s 6 amend the Food Act 2014 and s 8 and s 9 amend the Dietary Supplements Regulations 1985. The reason: after assent and before commencement, the TPA 2023 had already amended other laws; once repealed, those amendments had to be reversed, or dead cross-references would remain. The TPA 2023’s legal impact began at assent, not at commencement.

Insight 3: the government’s post-repeal intent is parallel lawmaking, not wholesale replacement. The Bill 67—1 explanatory material states that the government intends separate new schemes for medicines, medical devices and natural health products, with the current instruments remaining in force during the transition. This contrasts with the TPA 2023’s consolidation of medicines, devices and natural health products into one statute. A standalone natural health products bill has been confirmed (Cabinet papers CAB-26-MIN-0315 / SOU-26-MIN-0085, 25 September 2025).

Insight 4: the three timeline misreadings device companies most easily make. First, still treating 1 September 2026 as the TPA commencement date — nothing regulatory happens on that date. Second, assuming transition provisions exist after the repeal — the repeal Act set up none for devices, and the current regime has been unchanged since 2004. Third, misreading the repeal Act as a signal that “a new law is imminent” — it ended its force on 14 January 2025 and carries no forward-looking regulatory content.

4. Practical recommendations

• Clean all internal documents of TPA references. Search compliance manuals, tenders, client proposals and training materials for “TPA”, “Therapeutic Products Act” and “1 September 2026”, deleting statements that the TPA will commence on 1 September 2026 and replacing them with: the TPA 2023 (2023 No 37) was repealed by the Therapeutic Products Act Repeal Act 2024 (2024 No 55) on 18 December 2024 and never commenced.
• Pin verification conclusions at the official-number level. Use Therapeutic Products Act 2023 (2023 No 37) and Therapeutic Products Act Repeal Act 2024 (2024 No 55) in all writing, noting that the repeal Act self-repealed under s 10 at the end of 14 January 2025. Writing only “the TPA has been repealed” without numbers will draw requests for substantiation in compliance reviews.
• Plan production against the current three-layer framework. Deliverables consistently use the Medicines Act 1981 (1981 No 118, current version 10 July 2026), the Medicines Regulations 1984 (SR 1984/143) and the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325, current version 7 August 2020), and never place a bill not yet before Parliament on a project timetable.
• Run regulatory monitoring on a fixed rhythm, not event-driven. The TPA lasted about 17 months from assent to repeal, with repeated shifts of direction. GRZAN recommends a quarterly review of the device legislation pages on legislation.govt.nz and health.govt.nz, with “has a new Bill number appeared” as the only hard trigger.
• Retain the evidence chain that the regime did not change. Keep verification records for each key point in time (verification date, official URL, provision version), so that at any regime switch the company can show which law the Sponsor relied on.

5. Verification checklist

• □ No statement remains in internal documents that the TPA will commence on 1 September 2026
• □ The TPA 2023’s official number 2023 No 37 and assent date 26 July 2023 are recorded
• □ The repeal Act’s official number 2024 No 55, Bill number 67—1, assent 17 December 2024 and commencement 18 December 2024 are recorded
• □ It is noted that the repeal Act self-repealed at the end of 14 January 2025 under s 10
• □ The repeal Act’s s 3, s 5 / s 6 (Food Act 2014) and s 8 / s 9 (Dietary Supplements Regulations 1985) amendments are recorded
• □ Current compliance basis has reverted to the three-layer framework, with version dates noted (10 July 2026 / 10 July 2026 / 7 August 2020)
• □ The standalone natural health products bill is recorded per Cabinet papers CAB-26-MIN-0315 / SOU-26-MIN-0085 (25 September 2025)
• □ Regulatory monitoring runs on a fixed rhythm, with a Bill number as the trigger

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the New Zealand market. Our team manages adverse event reporting and recall coordination with Medsafe, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com