The Therapeutic Products Act 2023 (New Act) has now passed into law, marking the most significant change to New Zealand’s medicines, medical devices, and natural health products regulatory regime in the past 40 years. The New Act intends to modernise and replace the Medicines Act 1981 (Medicines Act) in a way that supports innovation while ensuring control over evolving technologies. Under the New Act, ‘therapeutic products’, which include medicines, medical devices, and certain natural health products will require market authorisation to be imported into, supplied within, or exported from, New Zealand.
Our experts outline below the key changes including the implementation timeline, and suggest how affected businesses can get ready for this new regime.
Market authorisation required for therapeutic products
Therapeutic products, including medicines, medical devices (which specifically include software), and certain natural health products will require market authorisation before they can be imported into, supplied within, or exported from, New Zealand. Market authorisation will be conditional on the new, independent regulator – the Therapeutics Product Regulator (Regulator) – being satisfied with a therapeutic product’s safety and quality. This new process will replace the Medicines Act’s current ministerial consent process.
A ‘therapeutic product’ is any product that is:
- intended for use in, on, or in relation to humans for a ‘therapeutic purpose’;
- deemed by the Therapeutic Products Regulations (yet to be drafted) to be therapeutic product; or
- intended for use as an active ingredient of a medicine.
The New Act’s definition of ‘therapeutic purpose’ is broader than it was under the Medicines Act and includes the purposes identified below. This widening of the purpose section intends to capture a wider and more comprehensive range of products and as a consequence will generate compliance obligations and costs that did not exist under the previous regime.
| ‘therapeutic purpose’ = new categories |
||
|---|---|---|
| preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for a disease, ailment, defect, or injury | influencing, inhibiting, or modifying a human physiological process | testing the susceptibility of humans to a disease or an ailment |
| influencing, controlling, or preventing human conception | testing for human pregnancy | investigating, replacing, modifying, or supporting part of a human’s anatomy |
| investigating a human physiological process | supporting or sustaining human life | providing vitamin, mineral, or other human nutritional supplementation |
| maintaining or promoting human health | disinfecting medical devices: | + as well as any purpose connected to those purposes |
Notably, the following product categories that did not require ministerial consent under the Medicines Act will require market authorisation under this new regime:
| Medical devices | Software as a medical device | Natural Health Products (NHP) |
|---|---|---|
|
Device that:
|
Software that
|
Product that
|
When do these new requirements come into force?
Despite the New Act having passed, most of its provisions have not come into force yet. Once in force, there will be transition periods for most existing products to obtain market authorisation under the new regime. The New Act provides that the last date by which the full regime must come into force is 1 September 2026. This staggered entry into force allows time for the Regulator to be established, regulations to support the Act to be drafted, and “rules” relating to certain matters to be developed.
| Transition periods for previously unregulated products | |
|---|---|
| Under the Medicines Act 1981 | Under the Therapeutic Products Act 2023 (once in force) |
| Unlisted medical device or unregulated product |
|
| Unregulated NHP |
|
| Transition periods for previously regulated products | |
|---|---|
| Under the Medicines Act 1981 | Under the Therapeutic Products Act 2023 (once in force) |
| Medical devices listed on the WAND Database |
|
| Medicines with existing consent |
|
| Medicines with provisional consent |
|
In addition, all pending applications for consent under the1981 Act will be considered as if the 1981 Act continued in force.
What should you be doing now?
Pending expiry of the Medicines Act, we recommend being proactive about educating yourself as to the application of the New Act, including identifying the steps to be taken to ensure you achieve compliance with the new regime by the relevant time and exploiting any opportunities that may arise. To prepare, you should:
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Assess the legal implications and opportunities: understand how the New Act’s specific requirements may affect your activities, products, and services. For example, in relation to NHPs, the New Act may materially impact the products you choose to offer, how you formulate those products, and how you choose to market those products going forward. While these steps may involve additional compliance costs, it is also an opportunity to improve product quality, increase trust in your product and align yourself with international good practices and standards.
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Plan your compliance solution: it may be that your product becomes regulated for the first time, or that you need to update your compliance solution in light of the New Act. If you are starting from anew, you could develop an obligations register which will outline the key obligations, use compliance management software to engrain these obligations within your organisation, and create a compliance officer role to oversee compliance with the register and engage with the Regulator (once established). This new process, or update to your processes, could also provide an opportunity to take advantage of opportunities to export your product to other jurisdictions that may have mutually comparable regimes regarding therapeutic products.
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Be informed: as the regime develops it is important to keep up to date with developments concerning the new regulations, rules and the Regulator. As a lot of the details concerning this new regime will be contained in regulations and rules, there will likely be further opportunities to impact the final shape of these secondary regulations and rules through a public consultation process. You can stay up to date with the alerts concerning the regime here.
Our experts welcome enquiries around how the New Act may impact you and your business, the engagement process going forward, and how to best implement a compliance solution that works for you.
This article was co-authored by Danielle Cooper, a Solicitor in our Corporate and Commercial team.
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