The Therapeutic Products Bill has been in the works for many years and was introduced into Parliament on 30 November 2022. This Bill will replace the outdated Medicines Act 1981 and Dietary Supplements Regulations 1985.
As interested parties will appreciate, this Bill aims to provide a comprehensive, risk-appropriate regulation of therapeutic products, including medical devices, natural health products as well as active pharmaceutical ingredients.
The Bill will regulate how products are manufactured, tested, imported, supplied and exported. This will include regulating:
- medicines from general sale products like paracetamol to gene, cell and tissue therapies
- medical devices ranging from tongue depressors to implantable pacemakers.
According to the Ministry of Health, both medical devices and gene, cell and tissue therapies are currently not fully regulated in New Zealand.
Natural health products will also be included in the Bill but they will be in a separate category from medicines and medical devices, under the category of ‘therapeutic products’ recognising that they are generally lower risk than medicines and medical devices.
The Health Select Committee have extended the deadline for submissions to the Therapeutic Products Bill. The new deadline is 5 March 2023 (updated on 7 February 2023).
A link to the Bill can be found here.
If you would like to know more about the Therapeutic Products Bill and likely affects these changes may have on your business, please get in touch.
