The TGA and pharmaceutical industry have been long preparing for the upcoming TGO 91/92 labelling reform deadline slated for 31 August 2020. However, as it has for many other sectors, COVID-19 has created difficulties for pharmaceutical companies to meet this labelling reform deadline. Therefore necessitating some interim measures.
The labelling reforms
As a refresher, 31 August 2020 marks the end of the 4 year transition period which commenced in August 2016. This transition period was intended to provide sponsors with ample time to align their medicine labels to 2 newly created labelling orders. These orders, listed below, replaced Therapeutic Goods Order No. 69 – General requirements for labels of medicines (TGO 69):
- TGO 91 – Standard for labels of prescription and related medicines
- TGO 92 – Standard for labels of non-prescription medicines
During the transition period sponsors can comply with either TGO 69 or TGO 91/92. However, come 1 September 2020 any medicine that is released must comply with either TGO 91 or 92 as applicable. Most pharmaceutical companies have been working towards aligning their labels to the new orders and gearing up for the end of the transition period. However due to the pressures of COVID-19 on supply chains, there are added challenges for sponsors to implement the changes in time for 1 September 2020.
In response to the unprecedented pressures introduced by the global pandemic, TGA has implemented interim exemptions for TGO 91 and 92 individually. Helping sponsors better manage the mandatory changes.
Exemptions to the Standard for labels of prescription and related medicines – TGO 91:a
From 1 July 2020, the TGA has introduced an interim streamlined section 14 process specifically for COVID-19. This provides sponsors of prescription medicines with a decision within 5 days of application fee payment. There is currently no end date for the interim process.
To be eligible for this expedited process, sponsors must:
- Currently be using approved labels that have been assessed for compliance with TGO 69
- Have received approval for new labels that were assessed against TGO 91
- Identify affected batch number(s) of the medicine 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.
- Pay the application fee via credit card
A new section 14 consent form specifically for COVID-19 has also been released for sponsors to use if the eligibility criteria is met. However should sponsors be unable to meet any of the eligibility criteria, they can still apply via the standard section 14 pathway if they wish.
Exemptions to the Standard for labels of non-prescription medicines – TGO 92:b
For listed, registered complementary, and over-the-counter (OTC) medicines, which are subject to TGO 92, the TGA has adopted a slightly different approach. This means sponsors of affected medicines can request for Section 14 consent to supply products that do not comply with TGO 92 due to adverse business impacts of COVID-19.
This time-limited measure effectively provides sponsors with more time to transition to TGO 92 labelling requirements.
To be eligible for this process, sponsors must:
- Currently be using approved labels that have been assessed for compliance with TGO 69
- Indicate whether COVID-19 has contributed to an inability to transition to TGO 92 by 31 August 2020
- Provide the name and ARTG number of the relevant medicines (including batch numbers where relevant)
- For multiple medicines under the same application, ensure that the request for consent relates only to non-compliance with TGO 92 in its entirety and is the same for all medicines
- Pay the applicable fees at the time of submission
Similar to prescription medicines, a new application form specifically for COVID-19 has also been released for non-prescription medicines.
Currently the end date for this consent is 6 March 2021. This aligns with the end of the transition period for the permitted indications reform also impacting non-prescription medicines. However a longer timeframe may be available under extenuating and exceptional circumstances for OTC and registered complementary medicines. This would provide pharmaceutical companies with an extension up to a 6 months.
Further information on the TGO 91 and 92 exemption pathways can be found on the TGA website:
- TGO 91 – https://www.tga.gov.au/form/covid-19-delays-adoption-tgo-91-labels
- TGO 92 – https://www.tga.gov.au/covid-19-and-eligibility-request-consent-supply-therapeutic-goods-do-not-comply-new-labelling-requirements-tgo-92
How we can help?
Our team of regulatory experts can guide sponsors through the TGO 91/92 labelling changes and assist in securing the relevant section 14 exemptions. Helping to ensure compliance and avoid any unnecessary medicine shortages in these unprecedented times. For more information please contact us: info@globalpharmasolutions.com