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Global Therapeutics Pty Ltd (Global Therapeutics) has paid penalties of $119,880 in response to nine infringement notices issued by the Therapeutic Goods Administration (TGA), part of the Department of Health. The infringement notices related to five listed complementary medicines sponsored by Global Therapeutics.
The advertising of these medicines was alleged to:
- refer to serious conditions without approval or permission of the TGA
- contravene requirements of the Therapeutic Goods Advertising Code (the Code)
- include therapeutic uses that were not accepted as indications for the medicines.
In particular, the Global Therapeutics' website allegedly contained unapproved references to 'serious' conditions such as upper respiratory tract infections, bronchitis, influenza, and viral and bacterial infections. The Code provides that representations about conditions requiring diagnosis, treatment or supervision by a suitably qualified health professional are 'serious', the use of which in advertising is restricted and not permitted for listed medicines.
Listed medicines are permitted to be supplied and advertised without full pre-market evaluation by the TGA as long as certain fundamental conditions are met to ensure the medicines are low-risk and suitable for self-selection by consumers. The onus is on sponsors to ensure compliance with these 'conditions of listing' and all other relevant requirements under the Therapeutic Goods Act 1989 (the Act). Contravening a condition of listing is behaviour that undermines the integrity of the trust-based listed medicines framework. Global Therapeutics allegedly breached one of these conditions by advertising their medicines for indications that were not accepted in the Australian Register of Therapeutic Goods (ARTG).
Sponsors of listed medicines must comply with relevant legislative requirements
Sponsors are reminded that at the time of listing a medicine on the ARTG, they certify that their medicine complies with all relevant requirements under the Act, which includes those in the Code. Sponsors also have an ongoing obligation to ensure that advertising for their medicine is compliant with all relevant legislative requirements and conditions of listing at all times, which include that all advertising material does not promote the medicine for therapeutic uses that are not accepted as indications in the ARTG entry.
The TGA is actively monitoring for non-compliance
The TGA conducts post-market compliance reviews of listed medicines and investigates signals of potential non-compliance, including the TGA's findings from routine monitoring of new or changed listings of medicines on the ARTG. This allows the TGA to determine whether listed medicines comply with relevant regulatory requirements, including conditions of listing and requirements relating to advertising. The infringement notices issued to Global Therapeutics stemmed from the TGA's monitoring of the ARTG and a subsequent investigation.
About infringement notices
The TGA can issue an infringement notice where it has reasonable grounds to believe a person or business has contravened the Therapeutic Goods Act 1989 (the Act). The payment of an infringement notice is not an admission of guilt or liability.