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Information for medicine advertisers: Additional allergen warnings effective 1 September 2020

7 September 2020

The Therapeutic Goods Administration (TGA) is reminding advertisers that additional mandatory health warnings for medicines containing specific allergens are required in certain advertising from 1 September 2020. The allergens, including tree nuts and tree nut products, are specified in Part of 4 of Schedule 1 of the Therapeutic Goods Advertising Code (No.2) 2018 (the Code).

Overview

In certain situations, the Code requires specific warnings about particular ingredients to be included in advertising for medicines. These warnings are specified in Schedule 1 and reflect the most serious warning statements that sponsors of registered and listed medicines are required to include on the labels of their products.

Part 4 of Schedule 1 of the Code takes effect on 1 September 2020, following the end of the transitional arrangements for the Therapeutic Goods Order No.92 - Standard for labels of non-prescription medicines and the Required Advisory Statements for Medicine Labels No.5 (RASML 5).

What this means for advertising

Goods not available for physical examination before purchase

Where an advertised medicine contains the allergens specified in Part 4 of Schedule 1 and is not available for physical examination before purchase, advertisers must include one of the following, prominently displayed or communicated:

  1. the statement "THIS MEDICINE MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE", followed immediately by information about where the health warnings can be found; or
  2. the statement "ALWAYS READ THE LABEL" and the health warnings for the medicine from Schedule 1 of the Code.

Goods that are available for physical examination before purchase

Where consumers are able to examine the goods before purchase, and can read the label, it is not necessary to include the health warning statement relating to allergens in advertising, although advertisers may choose to do so.  Health warning statements for the allergenic ingredients listed in Part 4 of Schedule 1 are not required to be included in advertisements regulated by section 13 of the Code.

Know your responsibilities

All advertising for therapeutic goods (including exempt goods) to consumers must comply with requirements in the Therapeutic Goods Act 1989. This includes the requirement to comply with the Therapeutic Goods Advertising Code.

Advertisers should consult the guidance material on the TGA website to familiarise themselves with their obligations under the Code.

More information

Further information about RASML 5 is available on the TGA website.