As of the 1st September 2020 all listed medicines released for supply on or after this date must be labelled according to the labelling order TGO92. Any medicines labelled as per TGO69 after 1st September 2020 will be non-compliant and should not be released for supply by the manufacturer.
The global pandemic has presented Australians with extraordinary health, economic and social challenges. AWRS has had personalised contact with the TGA on behalf of its valued sponsors to ask for grace from the deadline of 1st September compliance with TGO92, which is now unworkable for many businesses. Personalised TGA correspondence confirms that exemptions for compliance with TGO92 may be possible for businesses that have faced (and continue to face) unprecedented challenges within their businesses due to COVID-19. As a result the TGA will offer consideration to grant consent to supply medicines that do not comply with the requirements of TGO92. This interim measure will only apply for a certain period, if sponsors provide a satisfactory justification in relation to the adverse impacts of COVID-19 on the manufacturing and/or supply of their medicines. This consent can be sought by submitting a streamlined section 14 ‘consent to supply’ application. Further details on the information that the TGA would require from sponsors to substantiate disruption due to COVID-19 will be provided by the TGA shortly.
For listed medicines, the duration of a section 14 consent not to comply with TGO92 because of business disruptions caused by COVID-19 will be until 6 March 2021 only, which aligns with the end date for the transition to permitted indications.
Sponsors who require assistance in preparing s14 application for consent not to comply with TGO92 because of business disruptions caused by COVID-19 until 6 March 2021 should contact Rachael or Nadine.