Published: 2 March 2017

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The Medsafe Files – Episode Three: Product Categorisation

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Prescriber Update 38(1): 9-10
March 2017

What is Product Categorisation?

Product categorisation determines whether a product is a medicine, medical device, dietary supplement, supplemented food, psychoactive substance, cosmetic or related product. Product categorisation also determines the appropriate regulatory framework for the product.

Products with a therapeutic purpose are regulated under the Medicines Act 1981, while dietary supplements are controlled under the Dietary Supplement Regulations 1985. Dietary supplements, supplemented food and cosmetics are not permitted to make a therapeutic claim or contain any ingredients scheduled under the Misuse of Drugs Act 1975.

The current definitions of medicines, medical devices and therapeutic purpose can be found at www.legislation.govt.nz/act/public/1981/0118/latest/DLM53790.html.

Factors Influencing Categorisation

The categorisation process is dependent on the product ingredients, purpose of use and the manner in which it is presented in the market (ie, labelling or advertising). A number of factors are considered, such as the:

• indication claim
• mode of action of the product component associated with the indication
• alignment of the product component to the definition of medicine or medical device
• function of any ingredients in the product

For example, lubrication eye drops are categorised as a medical device due to its physical action, however, eye drops containing an ingredient with a pharmacological effect are categorised as a medicine. Antibiotic bone cement demonstrates the influence of the primary purpose on categorisation. Although the antibiotic prevents infection, the primary purpose of bone cement is to provide physical support, hence it is categorised as a medical device.

The same or similar product in New Zealand can be categorised differently overseas due to different legislation and regulatory schemes. Categorisation also depends on the claim the supplier submits to the regulator.

Further information on the categorisation of products in New Zealand is available at www.medsafe.govt.nz/regulatory/categorisation-of-products.asp.