The Therapeutic Goods Administration (TGA) is warning sponsors not to advertise listed medicines that are not included in the Australian Register of Therapeutic Goods (ARTG) with permitted indications.
Listed medicines that were not transitioned to use permitted indications were cancelled from the ARTG, effective 6 March 2021. If you are the sponsor of a listed medicine, you should be aware that this puts your medicines at risk of being unlawfully advertised.
Advertising medicines for indications not included in the ARTG
If you have transitioned your medicine to permitted indications, this effectively cancelled the medicine that included specific (free text) or coded indications in the ARTG with the old medicine being replaced by the new medicine using permitted indications
Only permitted indications included in the ARTG entry may be advertised, and it is unlawful to advertise any medicines for free text or coded indications that were previously included in the ARTG.
All sponsors must ensure that the therapeutic use, as described by the permitted indications in the ARTG entry, is of the same intent and meaning as the therapeutic use described on the label and in other advertising. Failure to do so provides grounds for regulatory action.
If you are the sponsor of a listed medicine, you are reminded that:
- the name of a medicine, claims made and overall presentation of the indications on the label and in other advertising material have the potential to imply a therapeutic use that is not of the same intent and meaning as the indications included in the ARTG entry-which is likely to result in the advertising of a medicine for indications not included in the ARTG entry
- the TGA has published guidance to assist sponsors with understanding legal requirements that apply to the advertising of listed medicines including the Permitted indications for listed medicines guidance and Advertising to the public: Complying with the Therapeutic Goods Advertising Code
- the TGA is actively monitoring for non-compliance, particularly in relation to the advertising of medicines for indications that are not included in the ARTG entry and/or not permitted for listed medicines
Consequences of breaking the law
There are criminal offences under the Therapeutic Goods Act 1989 (the Act) for the unlawful advertising of listed medicines. This includes circumstances where medicines are advertised for indications other than those included in the ARTG entry.
The legislation also provides for the imposition of civil penalties in the same circumstances which means that the TGA can issue infringement notices and take court action for alleged breaches of advertising laws.
In a recent case, a sponsor of listed medicines has paid penalties of $119,880 in relation to alleged contraventions of conditions of listing and provisions relating to advertising under the Act.
Reminder about supply
If you are the sponsor of a listed medicine, you are reminded that it is a criminal offence to import, export, manufacture or supply a therapeutic good in Australia if it is not included in the ARTG. It is also an offence for a wholesaler to supply therapeutic goods that are not included on the ARTG, to another person who is not the ultimate consumer of the goods. As such, if you supply a listed medicine that has been cancelled as a result of being transitioned to include permitted indications in the ARTG, you may be committing an offence under the Act.
The TGA does not intend to take regulatory action in relation to products that are still available for supply carrying specific (free text) or coded indications providing these were compliant prior to their release for supply. However, you must ensure that you review relevant state and territory laws carefully to ensure that you do not commit offences relating to retail supply of therapeutic goods.