NOTE 1
For a product to be regulated under the Medicines Act 1981, it must be intended to be used in humans for a therapeutic purpose.  Therapeutic purpose is defined in the Act as:

1. Treating or preventing disease; or
2. Diagnosing disease or ascertaining the existence, degree, or extent of a physiological condition; or
3. Effecting contraception; or
4. Inducing anaesthesia; or
5. Altering the shape, structure, size, or weight of the human body; or
6. Otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating or reducing or postponing, or increasing or accelerating, the operation of that function, or in any other way; or
7. Cleaning, soaking, or lubricating contact lenses.

NOTE 2
Medical device is defined in the Medicines Act 1981.  It means: any device, instrument, apparatus, or contrivance, including component parts and accessories thereof, that is manufactured, imported, sold, or supplied for use wholly or principally on or by one or more human beings for a therapeutic purpose; and includes bandages and other surgical dressings, except medicated dressings where the medication has a curative function that is not limited to sterilising the dressing; but does not include-

• Any ultrasonic therapy apparatus within the meaning of section 2 of the Physiotherapy Amendment Act 1953:
• Except in section 38 of this Act, any irradiating apparatus within the meaning of section 2 (1) of the Radiation Protection Act 1965.
• Any article of a kind or belonging to a class that is declared by regulations made under this Act to be a kind or class of article that is not a medical device for the purposes of this Act:

This definition of medical device is the current definition under NZ legislation and is the definition that must be applied when categorising products.  It is not consistent with other definitions used internationally which, while sensible, are not applicable in New Zealand.  For example, a pregnancy test kit is not a medical device (see definition of medicine); medicated dressing is not a medical device (see definition of medical device).

• Deliver or elute a chemical substance to achieve their therapeutic purpose (e.g., an IUCD that releases copper, a condom with spermicide),
• Should be sterile for safe use (e.g., saline irrigation solutions)
• Are implantable or injectable (e.g., a collagen injection).

NOTE 4
Related product is defined in the Medicines Act 1981.  A related product is a cosmetic or dentifrice or food in respect of which a claim is made that the substance or article is effective for a therapeutic purpose.  It does not include any medicine.

A product that is used "wholly or principally" for a therapeutic purpose is a medicine.  A related product has a therapeutic purpose that is not its principal purpose (e.g. a fluoride toothpaste, where the principal purpose is to clean the teeth).

Many products at the food-therapeutic product interface are likely to be related products (e.g. a capsule containing vitamins and minerals where the principal purpose is to supplement the dietary intake of those substances).

Definition of medicine
Medicine is defined in the Medicines Act 1981.  A medicine is any substance or article, other than a medical device, that is manufactured, imported, sold, or supplied wholly or principally for administering to one or more human beings for a therapeutic purpose (including use as a pregnancy test).

The following are not medicines:

• substances used in dental surgery for filling dental cavities

• bandages and other surgical dressings, except medicated dressings where the medication has a curative function that is not limited to sterilising the dressing

• any radioactive material within the meaning of section 2(1) of the Radiation Protection Act 1965

• any animal food in which a medicine is incorporated

• any animal remedy

• any other substance or article of a kind or belonging to a class that is declared by regulations made under this Act to be a kind or class of substance or article that is not a medicine for the purposes of this Act.

NOTE 5
Refer to the Cosmetic Products Group Standard 2006 published by the Environmental Protection Authority (EPA) under the Hazardous Substances and New Organisms (HSNO) legislation. This group standard includes lists of chemicals whose use in cosmetics is prohibited or restricted. It is available from www.epa.govt.nz/hazardous-substances/approvals/group-standards/Pages/cosmetic.aspx. Refer also to regulations 24 and 26-36 of the Medicines Regulations 1984 for requirements that apply to cosmetics.

NOTE 6
Dietary Supplements are regulated under the Food Act 1981 and are subject to the Dietary Supplements Regulations 1985 (administered by Medsafe).  These regulations specify a number of requirements for dietary supplements relating to matters such as composition, labelling and maximum permitted daily doses for many vitamins and minerals.

NOTE 7
Supplemented foods are regulated under the Food Act 1981 and are subject to the NZ Food (Supplemented Food) Standard 2010.  The standard can be downloaded from http://www.foodsafety.govt.nz/elibrary/industry/Zealand_Food-Regulations_Regulations.pdf.  Contact the Ministry of Agriculture and Forestry (http://www.foodsafety.govt.nz/contact-us/) for further information on the regulation of supplemented foods.