Upgraded over-the-counter medicines online application system

Available from: 9 April 2014

7 March 2014

From 9th April 2014, over-the-counter medicines applications will be submitted through an upgrade to the OTC medicines online application system.

Applications will be easier to submit and process and industry will benefit from this reduction in regulatory burden.

Access to the upgraded system will continue to be through the eBusiness Services website.

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 9th 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.

OTC Medicines online application system
Non-prescription medicine application system

Testing and consultation

Following the introduction of the OTC application categorisation framework in March 2013, the TGA undertook to upgrade the OTC online application system to support the new framework.

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.