Advertising and making claims for therapeutic goods

Foundation

9 June 2017

Education and training to support small to medium enterprise

Introduction

As part of a program of support for Small to Medium Enterprises (SMEs), we have identified a number of education and training topics that will help SMEs, and others who may not interact with us frequently or often, to understand key issues around the regulation of therapeutic goods in Australia.

Overview

The TGA regulates and monitors therapeutic goods supplied in Australia including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood and tissue products.  This ranges from assessing applications to enter products in the Australian Register of Therapeutic Goods (ARTG), for clinical trials and for access to unapproved goods (for supply in Australia where they are not on the ARTG).

Advertisements for therapeutic goods are subject to a number of laws and regulations. These include the Therapeutic Goods Act 1989 and other legislation such as the Competition and Consumer Act 1990. Some therapeutic goods including prescription and certain pharmacist-only medicines, as well as biologicals, are prohibited from being advertised directly to the public.

When you advertise a product to the public or produce any consumer material that promotes the use or supply of your good, whether in print media (for example, newspapers and magazines), on billboards, in leaflets or brochures, or via electronic media and the internet, you need to understand your obligations and what is legally required.

This educational material offers an overview of:

  • various advertising mediums
  • the requirements you need to meet
  • the role of the TGA and other bodies in ensuring the compliance of marketing and advertising of therapeutic goods in the Australian community.

Target audience

This topic is specifically targeted to those new to regulatory processes in Australia. You will benefit from this material if you intend to market or advertise your product in Australia.

Learning objectives

At the end of this training you should have a better understanding of:

  1. what can be considered advertising
  2. your legal obligations and responsibilities in relation to therapeutic goods advertising
  3. how the TGA and other authorities ensure advertising compliance
  4. how we receive and manage complaints, including how we apply sanctions or penalties or take other regulatory action

Course outline

This training will be delivered by TGA officers. It will include presentations and case studies highlighting how we require advertisers to meet their obligations and how these obligations are applied in practice.

Where a course is delivered face-to-face or in a live environment, you will have the opportunity to ask questions and/or participate in group discussion.

Course delivery

We recognise it is important to deliver education and training in multiple ways. If there is sufficient interest, we will also:

  • deliver face-to-face workshops with a panel of experts and a facilitator (a half- or full-day session)
  • offer webinars and training packages via the TGA website
  • partner with peak groups and stakeholders to deliver joint training at conferences, forums and other events.

Under this topic, a range of courses will target how advertising to the public is regulated in relation to, in particular:

  • non-prescription and complementary medicines
  • medical devices (including IVDs)
  • other therapeutic goods such as sunscreens and disinfectants.

Register your interest

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Event details

As specific training dates and events are announced they will appear below:

  • Date: TBA
  • Location: TBA
  • Cost: TBA