The Therapeutic Products Bill became the Therapeutic Products Act on 26 July 2023, marking the beginning of a complete overhaul of the way in which therapeutic products are regulated in New Zealand. We have written about the objectives of the Act in our Therapeutic Products Bill set to improve the health of all New Zealanders article. The Act will impact every stage in the lifecycle of medicines, medical devices, medical software, and natural health products (eg dietary supplements) – from the development and testing process, to manufacturing, right through the supply chain, to advertising, wholesaling and exporting.
What will happen next?
The Act will come into force by 1 September 2026. Between now and then, all eyes will be on the Ministry of Health as it prepares and consults on the regulations and rules required to give the Act practical effect. For many therapeutic product businesses – especially those in the medical device, medical software and the natural health sectors – the content of those regulations and rules will determine the level of impact the legislation will have on their operations and ultimately, their financial bottom line. For that reason, we encourage all affected businesses to actively engage in the consultation process, whether individually or via industry associations.
What will happen when the legislation comes into force?
The legislation contains transitional provisions that will apply from the date that the Act comes into force. Amongst other things, the provisions automatically grant "market authorisations" (ie approvals) and licences for products that are lawfully in the market on the day the Act commences so that those products can continue to be manufactured and supplied. This will give affected businesses time to apply for and obtain the necessary market authorisations, licences and/or permits they will need to operate lawfully under the Act. The duration of the authorisations differs significantly across product types. As the legislation currently stands:
- Medicines that have approval under the current Medicines Act will automatically have "permanent" market authorisation
- Medical devices that are subject to the Medicines (Database of Medical Devices) Regulations 2003 will automatically have a temporary authorisation of either three or five years (depending on their class)
- Devices that are exempt from the Medicines (Database of Medical Devices) Regulations (eg in vitro devices) will automatically have a temporary authorisation of six months.
It will be critical that organisations that are involved in clinical trials, or the development, manufacture, supply or export of therapeutic products, to understand exactly what temporary market authorisations and/or licenses will automatically apply to each of their therapeutic products and their current business activities, and to plan for making applications for the appropriate market authorisations, plus any necessary licences and/or permits, by the time the temporary versions expire. If an organisation fails to do so, it could find itself without the legal right to carry on activities that are essential to its business.
Want more information?
You can read more about the legislation in our previous articles:
- Will the Therapeutic Products Bill prevent you from growing lemons and purchasing cinnamon?
- Proposed regulation of health software
- Major changes on the horizon for medical device businesses
- Therapeutic Products Bill set to improve the health of all New Zealanders.
Please note that since we published these articles, some changes were made to the Bill by the Select Committee, and through the Committee stage in Parliament.
Buddle Findlay will be writing more updates and hosting presentations on what the legislation will mean for various industry groups. If you would like to stay up-to-date, please subscribe to our health legal updates. If you would like specific advice about how the reforms will affect your business, please contact one of our therapeutic products experts.