Revised: 22 June 2015
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.
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.
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.
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.
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.
(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|
|Dental cement with antibiotic / adrenaline|
|Dermal Fillers (e.g. collagen injections) with / without local anaesthetic included in the formulation|
|Douches for body "cleaning"|
|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|
|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|
|Vascular balloons with / without medicinal coating||Medical device|
|Urea ointment for nail debridement||Medical device|
|Ultrasonic therapy apparatus||Medical device|
|Water for injection||Medicine|
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.
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;
Therapeutic purpose - means any of the following purposes, or a purpose in connection with any of the following purposes:
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 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.
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 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
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.