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There are a number of regulatory requirements for importing, distributing or otherwise supplying therapeutic products in New Zealand. If you are thinking about importing or supplying a therapeutic product in New Zealand, make sure that:

  • your product is compliant with New Zealand laws; and
  • you are aware of your legal requirements as the product sponsor. 

Current Therapeutic Product Regulation 

In New Zealand, there are certain requirements for approval, classification, manufacture, sale, distribution, advertising, prescribing and dispensing of therapeutic products. The body responsible for administering the regulatory framework in New Zealand is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). Medsafe works to ensure therapeutic products are of an acceptable standard of safety, quality and efficacy. 

Some therapeutic products, such as narcotic and psychotropic products, are classified as controlled drugs. These products face other legal regulations. 

What Is a Therapeutic Product?

A therapeutic product includes medicines, medical devices and other related products. Therapeutic products are products for use in or on humans for a therapeutic purpose. Therapeutic purpose means (as well as meaning a purpose in connection with any of the following): 

  • preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for a disease, ailment, defect or injury;
  • influencing, inhibiting or modifying a physiological process;
  • testing the susceptibility of persons to a disease or ailment;
  • influencing, controlling, or preventing conception;
  • testing for pregnancy; or 
  • investigating, replacing, or modifying parts of the human anatomy.  

Your product may be a therapeutic product if you claim or imply a therapeutic purpose for the product. For instance, this could be via a claim on the product labelling.

For example, an e-cigarette product that makes therapeutic purpose claims, such as “supports or aids smoking cessation”, will be considered a therapeutic product.

The regulation exempts certain products and product types if you meet certain conditions. For example, this includes oral hygiene products like toothpaste or mouthwash. The Medicines Act does not regulate oral hygiene products, provided that:

  • such products do not contain a substance which is a scheduled medicine; and
  • any claimed benefits from the use of the product only relate to improvements in oral hygiene and prevention of tooth decay. 

Medicines

A medicine is a substance which:

  • is manufactured, imported, sold or supplied for administering to a human for a therapeutic purpose; and
  • achieves, or is likely to achieve, its principal intended action in or on the human body by pharmacological, immunological, or metabolic means. 

Medicines in New Zealand are generally classified under three categories. These categories are: 

  • prescription medicines;
  • restricted medicines; and
  • pharmacy-only medicines.

Prescription medicines are medicines that can only be sold, supplied or administered in accordance with a prescription given by an authorised prescriber. An authorised prescriber could be a nurse practitioner, medical practitioner or dentist.

Restricted medicines are medicines that you may sell without a prescription. However, only a registered pharmacist in a pharmacy can sell them. 

Pharmacy-only medicines are medicines that you may sell in:

  • community or hospital pharmacies; or
  • a shop in an isolated area that has a license to sell that particular medicine.

Any salesperson can sell pharmacy-only medicines. 

Some herbal remedies are also regulated as medicines under the Medicines Act. Herbal remedies do not contain prescription, restricted or pharmacy-only ingredients. 

Related Products

A related product is a product that is a food, dentifrice or cosmetic product that is claimed to be effective for a therapeutic purpose.

For example, certain vitamin supplements and antiseptic throat lozenges are related products. 

Antiperspirants, most moisturisers, anti-wrinkle and anti-ageing products which have a superficial cosmetic effect (and not physiological effect) and general use antiseptics are all cosmetic products. You do not need consent to distribute these products in New Zealand. 

Medical Devices

A medical device is any device, instrument, apparatus or appliance that is intended to be used primarily on human beings for a therapeutic purpose. This is provided it does not achieve its principal intended action by pharmacological, immunological, or metabolic means.

Currently, medical devices do not have strict regulations in New Zealand. Unlike medicines and related products, the only requirement for supply of a medical device in New Zealand is to file an online notification via the Web Assisted Notification of Devices (WAND) portal. The New Zealand sponsor of the medical device must file a WAND notification and must include details such as the: 

  • risk classification of the device;
  • name of the manufacturer and sponsor of the device (together with their relevant business addresses and contact details); and 
  • product description attributed to the device by the Global Medical Device Nomenclature System. 

The government has been working to develop a new regulatory framework for therapeutic goods, which would look to replace the existing Medicines Act and more fully regulate medical devices in New Zealand. 

Distributing or Supplying Medicines and Related Products in New Zealand

You must obtain consent from the Minister of Health before you can distribute, sell or advertise your medicine or related product in New Zealand. You must: 

  • submit an application for consent to Medsafe; and 
  • comply with the requirements of the Medicines Act. 

Medsafe will make an initial assessment to ensure that you have:

  • submitted your application in the correct category; and
  • provided all the required data.

The application will then progress to the evaluation phase. In this phase, Medsafe will determine that your application sufficiently demonstrates the safety, quality and efficacy of your product and that the benefits outweigh the risk of harm to the patient. If this phase is successful, Medsafe will recommend that the Minister should grant consent. 

The New Zealand resident manufacturer or importer of a therapeutic product is the “sponsor” for the product. As the sponsor, you are responsible for ensuring the therapeutic product is compliant with New Zealand laws, including in relation to advertising and promotion, undertaking product recalls and withdrawals and reporting adverse reactions.

Sometimes a patient may require treatment by a medicine that has not been approved for use or supply in New Zealand. Access may be provided to such unapproved medicines via special pathways, such as a clinical trials scheme, compassionate use supply for a named patient, or an authorised prescriber (the practitioner exemption). 

Key Takeaways

Therapeutic products can present serious risks of harm, especially if manufactured, advertised or used inappropriately or in ways that do not comply with applicable regulation. If you need advice about distributing or advertising your therapeutic products in New Zealand, contact LegalVision’s commercial health lawyers on 0800 005 570 or fill out the form on this page.

FAQs

What regulation is there over New Zealand therapeutic products?

In New Zealand, there are certain requirements for approval, classification, manufacture, sale, distribution, advertising, prescribing and dispensing of therapeutic products.

What is a therapeutic product?

A therapeutic product includes medicines, medical devices and other related products.

What is a medical device?

A medical device is any device, instrument, apparatus or appliance that is intended to be used primarily on human beings for a therapeutic purpose

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