This upgrade is part of the staged implementation of the harmonisation of OTC medicines business processes in Australia and New Zealand.
The existing system will go off-line just before midnight on Sunday 6th April and the upgraded system will become available at 6:00am Wednesday 9 April. The intervening two working days will be used to configure applications that are currently on hand, into the upgraded system.
Features of the upgraded system
New features of the system include:
built-in validation 'rules' that provide prompts on information that is required to be submitted with an application
clear prompts as to the supporting documents required for each application category
the ability to submit supporting documentation as electronic attachments directly through the system
enhanced visibility to the applicant of the status of their application from the date of submission until finalisation.
The upgraded application submission system has been tested by a small group of industry stakeholders, and in December 2013 industry forums were held to demonstrate the key features of the upgraded system.
At the December forums, industry advised the TGA that a reasonable period to give notice about the upgrade date was 4 weeks.
Questions and answers
What will happen to submitted applications that are still awaiting finalisation?
Submitted applications will be retained in the upgraded system and continue to be processed. No further action is required on the part of the applicant. The two day configuration period (on 7th and 8th April) will be used to define the system characteristics for each application that will enable the enhanced visibility of status to applicants.
What will happen to applications that are in draft in the system but not yet submitted?
The TGA expects draft applications to be preserved, but we do not make any warranty to this effect.
If you are concerned about losing work saved in the online application system, we advise you to save a copy of each partly completed application outside the system.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.