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COVID-19 and eligibility to request consent to supply therapeutic goods that do not comply with the new labelling requirements of TGO 92

9 March 2021

The COVID-19 pandemic has placed unprecedented pressures and challenges on the pharmaceutical industry, including difficulty in implementing the new medicine labels that comply with the new labelling orders (TGO 91/92) for medicines that come into force on 1 September 2020.

In recognition of these challenges, the Therapeutic Goods Administration (TGA) has established a temporary process for sponsors of listed, registered complementary, and over-the-counter (OTC) medicines to request consent to supply products that do not comply with TGO 92 due to adverse business impacts of COVID-19. The end date for this consent was 6 March 2021. Sponsors requesting consent not to comply with a standard applicable to their goods will now be required to submit the general Application for consent to import, supply or export goods that do not comply with standards - section 14/14A.

Duration of consent not to comply

This is a time-limited measure to provide affected sponsors more time to transition to the requirements for TGO 92. In general, the opportunity to apply for consent not to comply ceased on 6 March 2021, which aligned with the end of the transition period for permitted indications, a reform that also involved implementation of major label changes. However, a longer consent period may be considered for OTC and registered complementary medicines under exceptional circumstances. Please refer to the links below for further information relating to seeking a section 14 consent not to comply for your specific medicine (Listed medicines or OTC and registered complementary medicines).

The application form can be found here:

Overview

All therapeutic goods included in the ARTG and supplied in Australia must comply with any standards applicable to the goods, such as Therapeutic Goods Orders, and it is an offence to import, supply or export therapeutic goods that do not comply with these standards (Section 14 of the Therapeutic Goods Act 1989 (the Act). Civil penalties may be incurred if goods are found to be non-compliant.

The Therapeutic Goods Order No.92 - Standard for labels for non-prescription medicines (TGO 92) is a standard made under section 10 of the Act following extensive industry consultation. TGO 92 mandates the information that must be included on labels of all listed, over-the-counter and registered complementary medicines. Compliance with TGO 92 contributes to the quality use of medicines by Australian consumers and healthcare professionals.

TGO 92 was implemented in September 2016 with a four-year transition period. All medicines released for supply from 1 September 2020 must be labelled in accordance with TGO 92. However, in recognition of the additional challenges that COVID-19 has caused for some pharmaceutical companies, the TGA provided eligible industry members across all relevant medicine sectors the opportunity to request an exemption to comply with TGO 92 by submitting a section 14 consent not to comply application. The closing date for lodging these applications was 6 March 2021.

Note: the section 14 consent not to comply process described on this page is separate from the consent to supply therapeutic goods that do not comply with subsection 9(2) of TGO 92.

Consent not to comply with subsection 9(2) of TGO 92 is a measure that is available to sponsors having difficulty complying with the TGO 92 requirements for the presentation of the medicine name and has a consent duration that extends past 6 March 2021.

What is eligible for a consent?

Each medicine industry sector is experiencing challenges due to COVID-19; hence, sponsors of listed, OTC and registered complementary medicines were able to seek a section 14 consent not to comply with TGO92 provided the product(s) is fully compliant with TGO 69.

Listed medicines

For sponsors of listed medicines, the duration of the section 14 consent not to comply with TGO 92 because of business disruptions caused by COVID-19 ended on 6 March 2021. This aligned with the end date for the transition to permitted indications.

OTC and registered complementary medicines

For sponsors of OTC and registered complementary medicines, the section 14 consent not to comply with TGO 92 due to disruptions caused by COVID-19 also ended on 6 March 2021. Longer timeframes were provided to some medicines in extenuating and exceptional circumstances.