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COVID-19 delays to adoption of TGO 91 labels
This expedited pathway for section 14 consents for supply of medicines without TGO 91 compliant labels ceased on 9 October 2020.
Any sponsors still requiring consent to supply labels not compliant with TGO 91 can apply via the standard section 14 process.
The transition period from TGO 69 to TGO 91 will expire on 1 September 2020. However, due to the pressures of COVID-19, some prescription medicine manufacturers are experiencing difficulty introducing TGO 91 assessed labels into their manufacturing process.
In response, the TGA has implemented a streamlined section 14 process. The new s14 process will provide a decision within 5 days of the application fee being paid and will be available to sponsors from 1 July 2020. To be eligible for the new process, the sponsor must:
- Currently be using approved labels that have been assessed against TGO 69.
- Have received approval for new labels that were assessed against TGO 91.
- Make payment via credit card.
- Use the new s14 consent form for COVID-19 (see below). The pdf version will automatically calculate the fee payable and is recommended for use whenever possible.
The sponsor will need to identify affected goods by reference to batch number(s) or a time period which would cover manufacture of the affected batches. If using the latter approach, a rationale for the time period must be provided.
If all of the criteria above are not met, consent will not be given. However, the sponsor may still apply for section 14 consent via the standard s14 pathway.
Any questions can be addressed to TGO91.COVID.Delay@health.gov.au.