Compliance

Marketing Products Which Are Not Approved Medicines

Introduction
Marketing of medicines supplied under exemption provisions in the Medicines Act 1981
Marketing products intended to be supplied as “complementary health care products”, “natural health products”, dietary supplements, etc.
Further information

Introduction

This page provides guidance in relation to marketing of:

unapproved medicines supplied through the exemption provisions in sections 25 to 32 of the Medicines Act 1981. These cannot be advertised.
products intended to be supplied as “complementary health products”, “natural health products”, dietary supplements etc. These are not medicines. (Note that currently there is no legislation that permits the marketing of products with low level therapeutic claims, often referred to as “complementary health care products” or “natural health products”).

This page does not provide guidance in relation to marketing of:

approved medicines
medical devices
controlled drugs.

The Medsafe website contains guidance to determine whether your product is a medicine according to the Medicines Act 1981.

If your product has a therapeutic purpose, and meets the definition of a medicine, the requirements of the Medicines Act 1981 apply.

Medsafe operates this approval system for medicines.

Marketing medicines supplied under exemption provisions in the Medicines Act 1981

This section provides guidance on marketing products which are exempt from the requirements of section 20 and 24 of the Medicines Act and are considered unapproved medicines. These products cannot be advertised.

There are some instances where medicines are exempt from the requirement to be approved before distribution (i.e. exempt from section 20 and 24 of the Medicines Act). Exemptions for these unapproved medicines are defined in the Medicines Act 1981, sections 25 – 33. Although sections 25 – 33 of the Medicines Act provides an exemption in some circumstances from the requirement for approval), this does not include any exemption regarding advertising these unapproved medicines.

The definition of advertisement / advertising in the Medicines Act is broad. It applies to all entities, which includes anyone advertising a medicine, regardless of whether they are directly involved in sale of the medicine or not. It also applies to all audiences, including advertising targeting the general public and healthcare professionals.

Medsafe interprets the Medicines Act regarding advertising as below.

Publishing the availability, or future availability, of an unapproved medicine is advertising. This includes publication in newspapers, on websites, in social media, on TV or radio, in presentations and by word of mouth.
Availability of an unapproved medicine cannot be indicated in any way to anyone. Medsafe has accepted that enquiries about a medicine by a health care professional may be responded to on the basis that provision of product information to a health care professional who is considering prescribing is acceptable. This is on the basis that a healthcare processional who needs to make a prescribing decision, may need to procure certain information from suppliers of unapproved medicines to assist them in making an informed decision for their patient. Medsafe would not accept a supplier suggesting that enquiries should be made about an unapproved medicine.
Advertising covers both public and private communications and applies to communications to members of the public and to health care professionals.
Personal representation is advertising. For example, product representatives visiting health care professional to promote an unapproved medicine is advertising.
Prospective supply of prices lists is advertising. For example, if a price lists is supplied unsolicited or placed on a website, Medsafe considers this to be advertising. This is advertising the availability of an unapproved medicine.
In the interests of clinical safety, Medsafe has accepted that information provided in the New Zealand Formulary in relation to unapproved medicines is acceptable as provision of essential information to prescribers. This is on the basis that it provides prescribers with important safety information relating to medicines. Suppliers must not use this avenue to market a product.
Medsafe has accepted the inclusion of funded unapproved medicines in the PHARMAC schedule. This is on the basis that PHARMAC is providing essential funding information to prescribers, which will assist their prescribing decisions in relation to essential medicines for patients.
Provision of any information relating to unapproved medicines, or the potential availability of medicines in the future at scientific / clinical / professional conferences would be regarded as a breach of the Medicines Act, regardless of the content or audience.

Marketing products intended to be supplied as “complementary health care products”, “natural health products”, dietary supplements, etc.

This section provides guidance on advertising products which are intended to be marketed as “complementary health care products”, “natural health products”, dietary supplements etc.

It is important to note although the terms “complementary health care product” and “natural health product” are widely used in New Zealand, they are not currently defined in legislation. Refer to the first section of this page for guidance on determine whether your product is a medicine.

Where these products do not contain a scheduled substance and are not intended for a therapeutic purpose, all marketing materials should be carefully managed to ensure that they do not infer a therapeutic purpose. If marketing materials infer a therapeutic purpose, these products would likely be considered medicines, and the requirements of the Medicines Act apply.

Advertising guidance

Medsafe does not approve marketing materials for products. Medsafe provides the following guidance in relation to advertising products which are not intended on being marketed as medicines:

Medsafe considers ‘marketing materials’ to include all types of material:
- the product label statements and claims,
- graphical, video and audio material,
- websites,
- depictions and context of advertising, for example advertising depicting a pharmacist selling a product to a patient could suggest it has a therapeutic purpose,
- education sessions,
- testimonials,
- provision of, references to or links to information about past or present traditional use,
- social media posts.
If marketing materials imply, allude to, suggest or refer to a therapeutic purpose, as defined in the Medicines Act, then they are medicines by virtue of their therapeutic purpose and associated claims.
Marketing materials which refer to a disease state, would be regarded as advertising a therapeutic purpose.
Marketing materials referring to symptoms would be regarded as making a claim for a therapeutic purpose.
Marketing materials include not only written or spoken words, but also the context. For example
- advertising depicting a pharmacist selling a product to a patient could suggest it has a therapeutic purpose,
- images showing people applying product to damaged or sore joints could suggest it has a therapeutic purpose,
- in some cases, the placement of an advertisement in media may be considered to imply a therapeutic purpose,
- representation at trade shows or conferences is advertising and must comply with these requirements.
There are no exemptions in the Medicines Act for advertising of “natural health products”, products traditionally used, homeopathic products, rongoa, or any other “complementary health care products”.
Note that, for natural therapists (and others), it is permissible to make a claim for a therapeutic purpose for a product when that product does not include a scheduled product and the claim is being made in the context of a consultation with or about an individual. Advertising on labels and in media is still not permitted. This is described in further detail on our website.

Therapeutic Advertising Pre-vetting Service

The Association of New Zealand Advertisers (ANZA) operates a pre-vetting system for advertisements for medicines, medical devices and related products – the Therapeutic Advertising Pre-vetting Service (TAPS). TAPS does not provide advice on categorisation of products or the legal status of products in relation to the Medicines Act 1981 (refer to the first section of this page). Before approaching TAPS, it is important to understand how your product is intended to be marketed, e.g. as a medicine, medical device, dietary supplement, etc.

Phone: +64 9 488 7455

All advertisers are strongly encouraged to use this service as a means of identifying any problems with their advertisements and obtaining advice on how those problems can be overcome.

Advertisers should be aware, however, that use of the pre-vetting service does not remove the liability of a company for the content of its advertisements. The pre-vetting service is able to provide guidance but does not guarantee compliance with the various advertising codes and the legislation.