The Therapeutic Products Act 2023 (Act) will come into force on 1 September 2026 (unless an earlier date is chosen by the Government). The Act consolidates the rules relating to all therapeutic products, replacing the Medicines Act 1981 and the Dietary Supplements Regulations 1985. It will be important for all manufacturers of medical devices to be aware of how the Act will affect the production and use of those devices.
What is covered
The definition of a therapeutic product is wide-ranging, covering products that are intended for use in, on, or in relation to humans for a therapeutic purpose, products that are intended for use as an active ingredient of a medicine, and any products that are specified in regulations.
Therapeutic products are divided into four types:
- medicines, which include pain relief available at supermarkets (such as paracetamol), vaccines, chemotherapy medicines, and patient-specific genetic treatments;
- medical devices, including products ranging from tongue depressors and bandages to implantable devices (such as pacemakers), cell-phone-based diagnostic software, and robotic surgery machines;
- active pharmaceutical ingredients (APIs), which are the active ingredients of medicines; and
- natural health products (NHPs), which include products such as vitamin and mineral supplements, herbal remedies, animal extracts, probiotics, enzymes, and essential fatty acids.
The Act provides for the regulation of all therapeutic products, to ensure that they are of acceptable quality and safety, that medicines and APIs are of acceptable efficacy, that medical devices have acceptable performance, and that the health benefit claims of NHPs are substantiated.
Although therapeutic products are products intended for human use, the Act also controls veterinary activities that involve the use of human medicines or medical devices for animal patients.
Market authorisation
Most medical devices will not be able to be imported, supplied, or exported unless they have a market authorisation (which will be issued by the Therapeutic Products Regulator), or there is a specific licence or permit. However, some custom-made devices are expected to be exempt from this requirement once regulations are developed.
Once a product has a market authorisation, the person to whom the authorisation was issued (known as the sponsor) is responsible for ensuring that the product conforms to the authorisation and meets the applicable product standards. The sponsor must be based in New Zealand, and must be considered to be a fit and proper person to be a sponsor. The sponsor will also have ongoing obligations in relation to post-market surveillance, record-keeping, record keeping, and reporting.
Market authorisation will only be automatically granted to medicines that are currently consented under the Medicines Act 1981. Other products, including all medical devices that were lawfully supplied in New Zealand before the Act comes into force, will have temporary authorisations. A sponsor will have between six months and five years in which to seek market authorisation, with the length of time depending on whether or not the device was an exempt medical device under the Medicines (Database of Medical Devices) Regulations 2003.
Controlled activities
The Act will regulate who can carry out controlled activities involving therapeutic products. These controlled activities include cover various aspects of the business of a medical device manufacturer, including:
- manufacturing;
- wholesale and non-wholesale supply; and
- exporting.
Every person in the supply chain for therapeutic products must comply with an extensive set of rules. Manufacturers of medical devices will need to follow rules relating to:
- when, where, how, and by whom the activity is carried on;
- the equipment and materials used;
- quality control and assurance processes; and
- having procedures in place to deal with expired or recalled items.
Penalties
Penalties for a breach of the Act for an individual can be imprisonment for a term not exceeding five years and/or a fine not exceeding $200,000, and for a company a fine not exceeding $1 million.
Civil penalties, for contravening specific provisions in the course of a business or undertaking, and for the purpose of making a commercial gain or avoiding a commercial loss, can result in having to pay the greatest of whichever of the following are applicable:
- if the conduct constituting the contravention was a transaction, the consideration for the transaction;
- if the contravention resulted in the person making a commercial gain or avoiding a commercial loss, three times the amount of the gain made or loss avoided as a result of the contravention (if it can be ascertained);
- if the person is an individual, $250,000; and
- if the person is not an individual, $2,000,000.
If you have any questions about how the Act may affect your business, or about health sector laws generally, please contact a member of our health law team.
You can read the other related articles here:
- The Therapeutic Products Act 2023 – key information for pharmacists
- The Therapeutic Products Act 2023 – key information for health practitioners
Disclaimer: The content of this article is general in nature and not intended as a substitute for specific professional advice on any matter and should not be relied upon for that purpose.
