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Advertising to the public

Complying with the Therapeutic Goods Advertising Code (No. 2) 2018

16 July 2020

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Schedule 1 - Medicine ingredients with specific health warnings

Guidance on specific Code provisions

The numbering of the sections corresponds to the numbering of the Code provisions for ease of cross-reference. However, this guidance does not cover all sections of the Code so the numbering may not be sequential.

This Schedule includes a table of medicine ingredients, circumstances and statements for the purposes of paragraph (a) of the definition of 'health warnings' in section 4. That paragraph provides that 'health warning', for a medicine that contains an ingredient mentioned in column 1 of the table in Schedule 1, in the circumstances set out in column 2 of that table, means the statement mentioned in column 3 of the table in Schedule 1.

The health warning statements listed in this Schedule 1 must be included in advertisements for a medicine containing an ingredient this schedule, in the circumstances required by sections 12(3)(f) and 13(2)(f) of the Code.

Parts 3 and 4 of Schedule 1 include health warnings for allergenic ingredients in registered or listed medicines. It is appropriate that advertisements for medicines containing these ingredients include the health warnings specified in those Parts of Schedule 1 when the medicine is not available for physical examination before purchase. Accordingly, only advertisements to which section 12 of the Code applies must, where relevant, include the health statements listed in Parts 3 and 4 of Schedule 1. In practical effect, the whole of Schedule 1 is potentially applicable to advertisements regulated by section 12.

However, it is not considered necessary to include the health warnings for medicines including allergenic ingredients in other advertisements where the consumer will be able to examine the goods before purchase and can read its label. The health warning statements for the allergenic ingredients listed in Parts 3 and 4 of Schedule 1 are therefore not required to be included in advertisements regulated by section 13 of the Code. Accordingly, only Parts 1 and 2 of Schedule 1 are potentially applicable to advertisements regulated by section 13.

This schedule reflects a set of the most serious warning statements that sponsors of principally registered over the counter medicines and listed (mostly complementary) medicines are or will be required to include on the labels of their products under a number of other requirements under the Act (for example, for listed medicines - the Therapeutic Goods (Permissible Ingredients) Determination No.3 of 2018, and for registered over the counter medicines - the Medicines Advisory Statement Specification 2017 and for both categories of medicine -Therapeutic Goods Order No.69 - General Requirements for Labels for Medicines 2017 and Therapeutic Goods Order No.92 - Standard for labels of non-prescription medicines). The statements in Schedule 1 have, where possible, been condensed, for suitability for inclusion in therapeutic goods advertisements, focussing on the most important health information for consumers to be aware of when considering buying a medicine, e.g. for Chlorhexidine, "Chlorhexidine can cause severe allergic reactions", or for Ibuprofen "Do not use if you have a stomach ulcer, impaired kidney function, heart failure, are allergic to anti-inflammatory medicines, or in the last 3 months of pregnancy".

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