On this page
-
…
Documents relating to the Medical Products Bill
Released 28 May 2026
On 7 April 2026, Cabinet agreed to further policy matters for the Medical Products Bill, including in relation to:
- The regulation of sunscreens and ‘boundary’ products
- Enabling safe access to medicines, including off-label use.
The Ministry has released a range of material relating to these decisions, including a Regulatory Impact Statement associated with the decision to regulate sunscreens under the Medical Products Bill.
- Cabinet Material: Medical Products (Sunscreen Regulations and Other Policy Matters) Bill.
- Regulatory Impact Statement: The regulation of sunscreens.
Released 14 October 2025
On 18 August 2025, Cabinet agreed to a range of policy matters for the Medical Products Bill, specifically about:
- the regulation of pharmacies, including pharmacy ownership and a new supervisory pharmacist role
- advertising of medicines and medical devices
- statutory timeframes
- how the Bill can support medical product exporters
- offences and penalties
- the role of Medsafe as the medical products regulator.
Further information can be found in media statements issued by Hon Casey Costello (Associate Minister of Health).
- Media release: Medical Products Bill taking shape
The Ministry has released a range of materials related to these decisions.
Released 19 August 2025
On 28 July 2025, Cabinet agreed to regulatory settings for supporting innovation under the Medical Products Bill. Cabinet’s decision provides clarity on how the Bill will regulate innovative medical products, clinical trials, and software as a medical device.
- Cabinet materials and advice: Supporting innovation through the Medical products Bill
- Regulatory Impact Statement: Clinical trials
- Regulatory Impact Statement: Innovative medical products and regulatory pathways to market
Medical Products Bill webinar
7 November 2024
On 7 November 2024, the Ministry of Health presented a public webinar on the planned Medical Products Bill. The Medical Products Bill is intended to replace the Medicines Act 1981, and to provide modern, risk-proportionate regulation of medicines and medical devices.
The webinar includes a question and answer segment. Not all questions could be answered during the available time, but these can be downloaded in the Q&A document below.
Transcript
Released 11 October 2024
- Cabinet material: Modernising the Regulation of Medicines and Medical Devices
Documents relating to the Therapeutic Products Act (2023)
Released 13 January 2024
- Cabinet material: Amending the Therapeutic Products Act Repeal Bill
Released 29 October 2024
This set of documents about the Therapeutic Products Act Repeal Bill was published on the New Zealand Parliament website.
- Health Committee’s report back on the Bill
- Ministry of Health Initial Briefing
- Ministry of Health Departmental Report
Released 5 August 2024
- Cabinet material: Therapeutic Products Act Repeal Bill approval to introduce
Released 21 June 2024
In 2023, the Ministry of Health commissioned a report on international approaches to the regulation of natural health products to assist in developing secondary legislation under the Therapeutic Products Act 2023 (the TPA). Following the Government’s announcement that it would repeal the TPA, all work on developing secondary legislation ceased.
On 8 May 2024, Hon Casey Costello announced her intention to develop a separate modernised regime for natural health products. The report on international approaches is being released as it may assist stakeholders in understanding how other countries regulate natural health products and support future engagement by the Ministry.
Released 23 May 2024
Released 24 August 2023
The Government has released key documents that led to its decision to amend the Therapeutic Products Bill to create an exemption regime for small-scale natural health product (NHP) producers and remove most obligations for rongoā.
We have released:
- advice provided to the Minister on direct to consumer advertising of prescription medicines (DTCA-PM)
- and a Regulatory Impact Statement (RIS) which provides analysis on both small-scale Natural Health Product (NHP) manufacturers and rongoā.
The Ministry’s Māori Health Directorate (Te Pou Hauora) has also released documents relating to advice given from the rongoā workstream to Ministers during development of the Act.
Released 13 June 2023
This set of documents was published on the New Zealand Parliament website.
- Health Committee’s report back on the Bill
- Manatū Hauora Initial Briefing (PDF, 1.1 MB)
- Manatū Hauora Departmental Report (PDF, 1.1 MB)
- Appendix 2 (clause by clause analysis) (PDF, 2.5 MB)
- Appendix 3 (response to questions from Oral Hearings) (PDF, 170 KB)
- Appendix 4 (Response to the Legislative Scrutiny Memo) (PDF, 844 KB)
- Appendix 5 (response to Regulations Review Committee) (PDF, 548 KB)
- Appendix 6 (Literature Review – Evidence of harm from NHPs) (PDF, 428 KB)
- Appendix 7 (Literature Review – DTCA-PM) (PDF, 345 KB)
Released 17 January 2023
- Cabinet paper: Therapeutic Products Bill: Approval for introduction (PDF, 712 KB)
- Legislation Committee minute: Therapeutic Products Bill: Approval for introduction (PDF, 673 KB)
- Cabinet minute: Therapeutic Products Bill: Approval for introduction (PDF, 684 KB)
Released 30 November 2022
- Regulatory Impact Statement: Therapeutic and Natural Health Products Regulation – Supplementary Analysis 2022 No 1
- Regulatory Impact Statement: Therapeutic and Natural Health Products Regulation – Supplementary Analysis 2022 No 2
- Cabinet paper: Pharmacy Ownership and Licensing (PDF, 663 KB)
- Cabinet minute: Pharmacy Ownership and Licensing (PDF, 660 KB)
- Regulatory Impact Statement: Pharmacy Ownership and Licensing
- Cabinet paper: Crown Liability under the Therapeutic Products Bill and Other Offence and Penalty Matters (PDF, 706 KB)
- Cabinet minute: Crown Liability under the Therapeutic Products Bill and Other Offence and Penalty Matters (PDF, 652 KB)
- Cabinet paper: Therapeutic Products and Natural Health Products Regulatory Scheme (PDF, 854 KB)
- Cabinet minute: Therapeutic Products and Natural Health Products Regulatory Scheme (PDF, 662 KB)
Released 17 March 2022
- Cabinet paper: Regulating Natural Health Products (PDF, 306 KB)
- Cabinet minute: Regulating Natural Health Products (PDF, 118 KB)
- Regulatory Impact Statement: Regulating natural health products
Released 14 December 2018
- Cabinet paper: Therapeutic Products Regulatory Scheme: Overview and Consultation on Bill Exposure Draft (PDF, 191 KB)
- Cabinet minute: Therapeutic Products Regulatory Scheme: Overview and Consultation on Bill Exposure Draft (PDF, 128 KB)
- Regulatory impact statement: Therapeutic Products Bill – Personal Import of Medicine by mail/courier
Minutes from November 2015 and March 2016 Cabinet papers
- Cabinet minute: Therapeutic Products Regulation Paper 1: Context and Overview (PDF, 144 KB)
- Cabinet minute: Therapeutic Products Regulation Paper 2: Proposals for a Therapeutic Products Bill (PDF, 141 KB)
- Cabinet minute: Therapeutic Products Regulation: Further Policy Approvals (PDF, 150 KB)
Released 28 April 2016
- Therapeutic Products Regulation Paper 1: Context and Overview (Word, 35 KB)
- Therapeutic Products Regulation Paper 2: Proposals for a Therapeutic Products Bill (Word, 157 KB)
- Regulatory Impact Statement 1 (for Cabinet Papers 1 and 2)
- Therapeutic Products Regulation Paper 3: Further Policy Approvals (Word, 46 KB)
- Appendix 1 for Cabinet Paper 3: A3 (PowerPoint, 68 KB)
- Regulatory Impact Statement 2 (for Cabinet Paper 3)
