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Therapeutic goods advertising compliance, 2018-19 annual report
Compliance and enforcement activities
Preventative compliance activities
Where the TGA becomes aware that an advertiser is planning a promotion that is likely to contravene the Act or the Code, we can take preventative action. As with our complaints handling, we apply a risk-based approach to these activities.
Section 20 of the 2018 Code sets out that an advertisement must not contain an offer of a sample (with some exceptions for certain therapeutic goods).
In September 2018, it came to the TGA's attention that Chemist Warehouse was proposing to provide sample bags, the contents of which included samples of therapeutic goods, in the form of seat cushions at the 2018 AFL and NRL Grand Finals.
The TGA assessed that the giving of the sample bags was a promotional activity that met the definition of 'advertise' in relation to therapeutic goods and that the advertisement offered a sample which would have contravened the 2015 Code.
The TGA intervened and requested that Chemist Warehouse not include therapeutic goods in the sample bags. Chemist Warehouse consequently did not include therapeutic goods in the sample bags, other than some approved sunscreen samples (which because of the inclusion of sunscreens in Schedule 3 of the 2018 Code, may be offered as a sample).
This outcome was published on the TGA website.
In 2018-19, the TGA investigated Peptide Clinics Pty Ltd for breaches of the mandatory rules for advertising of medicines, including the ban on advertising prescription-only medicines to the public. The Federal Court of Australia ordered a $10 million penalty against the company.
In 2018, the TGA investigated a South Australian man in relation to illegal acts involving counterfeit therapeutic goods. He was charged with various offences, including a criminal charge under section 42DL(1) of the Act for advertising these goods in a way that could cause harm or injury to a person.
Advertising cancelled goods
On 21 June 2019, the TGA issued an infringement notice to PharmaCare Laboratories Pty Ltd for contravening Section 42DLB of the Act. PharmaCare had advertised a product (Sambucol Kids Cold & Flu Liquid, AUST L 205425) that was cancelled from the ARTG on 3 June 2019.
Advertising goods not on the ARTG
On 3 January 2019, the TGA issued an infringement notice to a Sydney man for contravening section 42DL(3) of the Act. This decision was based on the reasonable belief that the man was publishing or broadcasting an advertisement on the internet about therapeutic goods that were not, at the time of publishing or broadcasting, registered or listed goods, or otherwise the subject of an exemption, approval or authority under the Act.