Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021
19Advertisements—medicines
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19 Advertisements—medicines
General requirements (1) An advertisement about a medicine must contain: (a) the name of the medicine within the meaning of TGO 92; and (b) one or more accepted indications for the medicine; and (c) the following statement, prominently displayed or communicated: ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE Additional requirements for advertisements that facilitate directly the supply of medicines not able to be physically inspected before supply (2) Where: (a) an advertisement facilitates directly the purchase or other supply of a medicine; and (b) the medicine is not able to be physically inspected by a consumer before the purchase or other supply;
Note: For paragraphs (a) and (b), an advertisement that facilitates directly the purchase or other supply of a medicine without prior physical inspection includes an advertisement that is published on a website, social media, or a software application, through which a transaction for the medicine may be conducted.
then the advertisement must also include:
(c) the name of the dosage form within the meaning of TGO 92; and
(d) the quantity of the medicine within the meaning of TGO 92; and
(e) each active ingredient; and
(f) if one or more health warnings apply in relation to the medicine—either of the following, prominently displayed or communicated:
(i) a list of the health warnings; or
(ii) a link to the health warnings.
(3) For subparagraph (2)(f)(ii), a link to health warnings in relation to a medicine must provide a consumer with direct access to the warnings or a document containing those warnings. (4) In this section:
accepted indication means:
(a) in relation to a medicine that is included in the Register—an indication that is accepted in relation to the inclusion of the medicine; or
(b) in relation to a medicine that is not included in the Register and is not prescribed for the purposes of subsections 42DL(12) and 42DLB(9) of the Act—an indication that is displayed on the label of the medicine.
Note: Regulation 7 of the Regulations prescribes therapeutic goods for the purposes of the offence and civil penalty provisions in subsections 42DL(12) and 42DLB(9) of the Act, respectively. Medicines prescribed in this regulation, and not included in the Register, must not be advertised to consumers. Medicines that are not prescribed, and not included in the Register, may be advertised to consumers.
health warning, in relation to a medicine (or an ingredient contained in the medicine), means a warning, contra-indication, precaution or restriction, that is: (a) required under a relevant instrument to be included on the label of the medicine; and (b) reasonably necessary to inform a decision of a consumer to purchase the medicine.