Over the counter medicines processes
13 November 2013
As part of the enhanced Business-2-Business arrangements (the first stage of progressive implementation work towards the establishment of the Australia New Zealand Therapeutic Products Agency (ANZTPA)), the TGA and Medsafe have reviewed the business processes for the evaluation of over the counter (OTC) medicine registration applications, to reform the current system, and develop a common approach in both countries.
The reforms are expected to:
- deliver more efficient and effective processes
- improve the quality of OTC medicine applications lodged with Medsafe and TGA
- provide sponsors of OTC medicines with greater clarity, transparency and predictability
- ensure that a process with an appropriate risk benefit model is used for market authorisation of OTC medicines
- enhance the transparency of decision making for OTC medicine applications.
The review phase for this project has been completed and the project entered the implementation phase on 15 April 2013. A Staged Implementation Plan was developed jointly by the TGA and Medsafe and in consultation with representatives of the OTC industry, covering the period from 15 April 2013 to 31 October 2014. This staged implementation plan is now being enacted, and is available on the TGA website and on the Medsafe website.
This work is also informing the harmonisation of business processes and work sharing for OTC medicines approvals, which is being undertaken by the TGA and Medsafe as part of the next phase of work towards increased regulatory alignment for the transition to ANZTPA.
Content last updated: 13 November 2013
Content last reviewed: 13 November 2013
Web page last updated: 13 November 2013