The Therapeutic Products Bill was quietly passed into law in late July 2023, to little fanfare despite the months of criticism levelled at the proposed law prior to its passing. The new Therapeutic Products Act (‘TPA’) is now in effect as of 27 July 2023, although a lengthy transition period means the majority of its provisions will not come into effect until 1 September 2026.

A new regime for therapeutic products

As we explained in January 2023, the TPA replaces the Medicines Act 1981 and Dietary Supplements Regulations 1985 with a new regulatory system for medicines, active pharmaceutical ingredients (‘APIs’), medical devices and natural health products (‘NHPs’).

‘Market authorisation’ will be required in order to import, supply or export medicines, medical devices and NHPs. Medical devices will also include software as a medical device – see our earlier article for information about what this means for the health software industry. 

Certain ‘controlled activities’ (including manufacturing, wholesale and non-wholesale supply, prescribing and administering, possession and conducting clinical trials) may only be carried out in relation to therapeutic products under licence or permit, or by persons specifically authorised by the TPA, such as pharmacists.

The TPA allows certain matters to be dealt with in separate regulations entered into under that Act. It is likely that any grey areas or areas of public contention will be tackled over the next 3 years through the secondary legislation process, and the finer details of the TPA will become clearer as we get closer to September 2026.

Original bill largely unchanged

Despite facing significant (and continued) opposition from both inside and outside of Parliament, the TPA remains largely the same as the version we reported on earlier this year. Key changes we have identified are:

• Provisions relating to advertisement of therapeutic products have been amended to ensure the TPA does not prohibit legitimate fundraising and advocacy activities relating to non-authorised products.
• The exemption for importing a non-authorised medicine for personal use has been extended to include prescription as well as non-prescription medicines, provided the medicine has been lawfully prescribed for the importer.
• Market authorisation and manufacturer licensing requirements no longer apply to NHPs (but remain for medicines) manufactured by rongoā practitioners for use in rongoā services and activities.
• The TPA expressly allows regulations to be made to permit certain NHPs to be manufactured without market authorisation or a manufacturing licence, and to allow non-wholesale supply of such products. This change is specifically targeted at small-scale producers of NHPs, although the scope of this exemption will be determined by regulation.
• In relation to software-as-a-medical device, the TPA now clarifies that cellphone-based diagnostic software is intended to be captured as a standalone medical device, and software-in-a-medical device is not (as such software will be assessed as a constituent part of the physical product).

Many other changes are clarificatory in nature and merely provide further detail about the types of products and activities captured by (or excluded from) the TPA’s reach.

What’s next?

Keep an eye out for further information from us about the implications of the TPA for your industry and the steps you will need to take in the lead-up to September 2026. We will be publishing more detailed guidance on the transitional process for medicines which hold a consent under the current regime, medical devices registered on WAND, and other products now subject to the TPA. If you have any questions in the meantime, get in touch with one of our experts.

Talk to the experts

Our specialists David Lewis and Hayley Miller have extensive experience advising members of the healthcare industry, including manufacturers of medicines, other therapeutic products and medical devices, and health software providers, on their regulatory obligations in New Zealand.

This article was written by Ashleigh Ooi, an Associate in our commercial, technology and privacy team.