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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

4 June 2020

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 will be 6 March 2021.

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 end date for the consent will be no later than 6 March 2021, which aligns with the end of the transition period for permitted indications, a reform that also involves 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).

This 6-month extension should provide a reasonable timeframe for industry to take stock of the impacts of COVID-19 and meet their regulatory obligations.

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 will provide 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.

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 can 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 will be until 6 March 2021 only. This aligns 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 will also generally be until 6 March 2021. Longer timeframes may be justified in extenuating and exceptional circumstances.

Regardless of the medicine type, each application should:

  • provide the name and ARTG number of the relevant product (including batch numbers where relevant)
  • indicate whether COVID-19 has contributed to an inability to transition to TGO 92 by the transition end date of 31 August 2020.

To streamline this process, evaluation of the product's label will not be required.

Instead, the TGA requests that sponsors indicate whether COVID-19 has adversely affected the sponsor's ability to have a TGO 92-compliant label from 1 September 2020. Adverse effects may include disruptions to:

  • staffing
  • resourcing
  • manufacturing
  • supply.

How to obtain consent

The person in relation to whom the goods are on the ARTG or an authorised representative of the person needs to:

  • complete and sign the application form
  • submit the form to the TGA together with the applicable fee

The applicant is responsible for satisfying the TGA that consent should be given. It is a serious offence to give information to the TGA that is false or misleading in a material particular for the purposes of making an application for consent under section 14/section 14A of the Act (see sections 136 and 137 of the Commonwealth Criminal Code).

If granted, the consent will only apply to the product(s) included in the application.

Fees

An application will not be considered unless the relevant processing fee has been paid. The fee is payable in relation to each application (see item 1A, Part 1 of Schedule 9 of the Therapeutic Goods Regulations 1990).

From 1 July 2020, there is a new fee structure applicable to section 14 application(s).