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Information for Industry

Revised: 22 June 2015

Categorisation of Products

See also: Changes to the Definition of Medicines and Medical Devices Effective 1 July 2014 - Actions for Sponsors

This guide has been prepared to help companies understand the factors that determine the category under which a product is regulated.

The categorisation of a product is determined by its ingredients, its purpose for use and the manner in which it is presented in the market.

Ingredients

Products categorised as dietary supplements, supplemented foods, cosmetics, or related products are not permitted to contain ingredients scheduled as Controlled Drugs under the Misuse of Drugs Act 1975 or scheduled as prescription medicines, restricted (pharmacist-only) medicines or pharmacy-only medicines under the Medicines Act 1981.

Medsafe's searchable database can be used to check whether an ingredient is scheduled under the Medicines Act. When searching for a substance in the schedule remember to check synonyms if the initial seach gives a "not found" result.

Lists of Controlled Drugs can be found in Schedules at the end of the Misuse of Drugs Act.

Purpose for use

Therapeutic claims are not permitted for products supplied as dietary supplements, supplemented foods or cosmetics. Independent advice is available on whether a claim implies a therapeutic purpose. The Association of New Zealand Advertisers offers a Therapeutic Advertising Pre-vetting Service (TAPS). For a fee an adjudicator will assess labels and advertising material and advise if it is compliant with NZ legislation. TAPS also offer advice on how statements could be modified to avoid non-compliance with the Medicines Act 1981. Alternatively there are a number of regulatory affairs consultants who specialise in advertising compliance. A list is available on this web site.

Another useful resource is the TAPS website. This website contains some guidelines on therapeutic claims and provides examples of claims that do not imply a therapeutic purpose.

Other sources of information

Distributors wishing to import unprocessed plant or animal material, should contact NZ Biosecurity to determine which import standards apply.

The New Zealand Customs Service is also able to advise on the requirements for commercial importation.

Copies of all the New Zealand Acts and Regulations discussed above may be downloaded for free from www.legislation.govt.nz

The following can be used to determine the appropriate regulatory coverage for a product.

 

Categorisation decision tree

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Categorisation Guidance

The following table provides categorisation information for various types of product.

The examples that have been selected for inclusion in the table are illustrative of product types that will change categorisation from 1 July 2014 or product types that lie close to the medicine / medical device interface.

Product Type Category
(from 1 July 2014)
Absorbable intra-ocular and synovial visco-elastic fluids used in surgery Medical device
Artificial tears or saliva
Blood bags with / without anticoagulant / preservative
Bone cement with antibiotic
Catheter with heparin / antibiotic coating
Contact lens lubricants and solutions
Condoms with spermicide / viricide / local anaesthetic
Cryogenic gases
Dental cement with antibiotic / adrenaline
Dermal Fillers (e.g. collagen injections) with / without local anaesthetic included in the formulation
Douches for body "cleaning"
Haemodialysis solutions
Haemostatic agents - collagen and non-medicated Medical device
Haemostatic agents - fibrin Medicine
Hormone eluting intra-uterine contraceptive devices Medicine
Injectable contrast agents for use in diagnostic imaging (e.g PET, CAT, NMR, X-Ray, Ultra-sound) Medicine
Intra-uterine contraceptive devices other than hormone eluting IUCDs (includes copper containing IUCDs) Medical device
In-vitro pregnancy tests
Irradiating apparatus
Lubricating gels with / without local anaesthetic included in the formulation
Manuka honey dressings provided the action of the honey is not described as being an antibiotic / antibacterial
Medicated dressings where the primary purpose of the dressing is to cover and protect the wound and provide an environment that supports healing (in contrast to being a delivery mechanism for the medication).
Peritoneal dialysis solutions and substances Medicine
Procedure kits (no medicines included) Medical device
Procedure kits which include an approved medicine in its original pack Medical device
Saline nasal sprays Medical device
Saline for injection Medicine
Solutions for irrigation Medical device
Tamponade solutions for eye surgery Medical device
Tissue adhesives (including fibrin based) Medical device
Toothpastes for sensitive teeth where the mode of action is physical (e.g by blocking open pores). Fluoride content (if any) must be no greater than that allowed in a general sales medicine Medical device
Total Parenteral Nutrition (TPN) solutions Medicine
Transdermal patches Medicine
Vascular balloons with / without medicinal coating Medical device
Urea ointment for nail debridement Medical device
Ultrasonic therapy apparatus Medical device
Water for injection Medicine

Requesting a Product Categorisation from Medsafe

If assistance is required in determining whether a product is a medicine or a medical device the sponsor of the product should collate the following information and submit this to Medsafe together with their request for the categorisation status of the product.

  • Name and contact details of the sponsor
  • Name and location details of the manufacturer
  • Name of the product
  • A description of the purpose of the product
  • Information about the mode(s) of action of the product
  • A description of the form of the product
  • Information about any regulatory approvals the product has from other regulators or notified bodies including;
    • The name of the regulator/notified body
    • The type of approval granted (CE Mark, FDA 510k, FDA Pre Market Assessment, TGA Registration or Inclusion, etc)
  • A copy of the promotional material for the product
  • URL of a website detailing the product
  • A copy of the product label

Medsafe may also request further information about the product in order to make a decision.

The above information should be submitted to Medsafe by one of the following methods;

  • Electronically - by email to devices@moh.govt.nz
  • Courier - to Medsafe, Level 6, 10 Brandon Street, Wellington, 6011
  • Post - to Medsafe, PO Box 5013, Wellington, 6145

Definitions

Therapeutic Purpose

Therapeutic purpose - means any of the following purposes, or a purpose in connection with any of the following purposes:

  1. preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury; or
  2. influencing, inhibiting, or modifying a physiological process; or
  3. testing the susceptibility of persons to a disease or ailment; or
  4. influencing, controlling, or preventing conception; or
  5. testing for pregnancy; or
  6. investigating, replacing, or modifying parts of the human anatomy
Medicine -
  1. means any substance or article that -
    1. is manufactured, imported, sold, or supplied wholly or principally for administering to 1 or more human beings for a therapeutic purpose; and
    2. achieves, or is likely to achieve, its principal intended action in or on the human body by pharmacological, immunological, or metabolic means; and
  2. includes any substance or article -
    1. that is manufactured, imported, sold, or supplied wholly or principally for use as a therapeutically active ingredient in the preparation of any substance or article that falls within paragraph (a); or
    2. of a kind or belonging to a class that is declared by regulations to be a medicine for the purposes of the Medicines Act; but
  3. does not include -
    1. a medical device; or
    2. any food within the meaning of section 2 of the Food Act 1981; or
    3. any radioactive material within the meaning of section 2(1) of the Radiation Protection Act 1965; or
    4. any animal food in which a medicine (within the meaning of paragraph (a) or (b)) is incorporated; or
    5. any animal remedy; or
    6. any substance or article of a kind or belonging to a class that is declared by regulations not to be a medicine for the purposes of the Medicines Act
Medical Device -
  1. means any device, instrument, apparatus, appliance, or other article that -
    1. is intended to be used in, on, or for human beings for a therapeutic purpose; and
    2. does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means (but may be assisted in its function by such means); and
  2. includes a material that -
    1. is intended to be used in or on human beings for a therapeutic purpose; and
    2. does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means (but may be assisted in its function by such means); and
  3. also includes -
    1. anything that is intended to be used with a device, instrument, apparatus, appliance, article, or material referred to in paragraph (a) or (b) to enable the device, instrument, apparatus, appliance, article, or material to be used as its manufacturer intends; and
    2. any device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is declared by regulations to be a medical device for the purposes of the Medicines Act; but
  4. does not include a device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is declared by regulations not to be a medical device for the purposes of the Medicines Act
Supplemented Food

Supplemented foods are regulated under the Food Act 1981 and are subject to the NZ Food (Supplemented Food) Standards 2010.

The standards can be downloaded from www.foodsafety.govt.nz.

Dietary Supplement

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.

Cosmetic

A product is a cosmetic if it is used to beautify, cleanse or protect the hair, skin. teeth or complexion.

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 restricted.
It is available from www.epa.govt.nz

Refer also to regulations 22, 24 and 26-36 of the Medicines Regulations 1984 for requirements that apply to cosmetics.

Psychoactive Substance

Psychoactive substances are regulated under the Psychoactive Substances Act 2013. This act contains the definition of psychoactive substances.

Further information is available at psychoactives.health.govt.nz

"Therapeutic type" Dose Form

A therapeutic type dose form is a presentation of the product in a form generally used in pharmaceuticals such as tablets, capsules and controlled amounts of oral liquids or powders.

A product is considered a supplemented food if it is represented as a food that has a substance or substances added to it or that has been modified in some way to perform a physiological role beyond the provision of nutritive requirement.

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