Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19
As described in the Upcoming TGA Deadlines for Medicine Labelling and Product Information Reform article the transition period for Australian Medicines Packaging Reform concludes on 31 August 2020.
As a reminder, the Therapeutic Goods Administration (TGA) introduced updated labelling requirements for medicines supplied in Australia, through the addition of two new labelling orders to replace the existing Therapeutic Goods Order No. 69 – General requirements for labels of medicines (TGO 69):
- TGO 91 – Standard for labels of prescription and related medicines (TGO91)
- TGO 92 – Standard for labels of non-prescription medicines (TGO92)
During the four-year transition period, companies could choose to comply with the old labelling requirements under TGO 69 or the new labelling requirements. Whilst companies can continue to store and supply medicines that are compliant with TGO 69 if they are released for supply on or before 31 August 2020. From 1 September 2020, all medicines released for supply must comply with either TGO 91 or TGO 92.
However, the COVID-19 pandemic has since 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). In recognition of these challenges, the TGA has established some interim processes to assist companies in managing their compliance with the standards.
Sponsors of listed, registered complementary, and Over-the-Counter (OTC) medicines can now request TGA consent to supply products that do not comply with TGO 92 due to adverse business impacts of COVID-19. This is a time-limited measure intended to provide companies more time to transition to the requirements for TGO 92. It is anticipated that the end date for the consent will be no later than 6 March 2021, however, a longer consent period may be considered for registered medicines under exceptional circumstances. (1)
To access this pathway, the sponsor must:
- currently be using medicine labels that are fully compliant with TGO 69
- submit their request using the nominated application form noting that an application can include multiple ARTG entries provided the request for consent relates only to non-compliance to TGO 92 in its entirety and is the same for all included goods
- only include a maximum of 20 ARTG entries in each application
- pay the nominated application fee
TGA have also implemented a new streamlined Section 14 consent process which can be used for Prescription Medicine label compliance. The streamlined Section 14 consent process will be available from 1 July 2020 and aims to provide applicants a decision within 5 days of the application fee being paid. (2)
To be eligible for the new process, the sponsor must:
- currently be using medicine labels that have been assessed to be compliant with TGO 69 and have received TGA approval for new labels that were assessed against TGO 91
- submit an application via the new Section 14 consent form for COVID-19 (expected to be released shortly)
- identify affected medicines 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 would need to be provided.
- pay the application fee via credit card.
In the event that a sponsor is unable to meet the aforementioned criteria, they will not be able to use the streamlined Section 14 process, however they may still apply for Section 14 consent via the standard pathway.
If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)
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