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Over the Counter Medicines Processes

The TGA and Medsafe are reviewing 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.

Review of the OTC medicines evaluation processes provides an ideal opportunity for Medsafe and TGA to collaborate in the development of a harmonised approach.

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.

A CEO Forum and a Working Group comprising industry representatives from Australia and New Zealand as well as Medsafe and TGA representatives, and consumers has been established to develop improved processes for evaluation of OTC medicines.

A consultation paper was released.

OTC Medicines Reform Consultation Paper - 13 September 2012

Medsafe and the TGA sought comments from interested parties on proposed reforms to the business processes for the evaluation of over-the-counter (OTC) medicines. A consultation paper outlining the proposed reforms was published on the Medsafe and the TGA websites with a deadline for submissions of 7 November 2012.

The period for consultation on the proposed reforms to the business processes for OTC medicines has now closed. Analysis of submissions is currently being undertaken and the outcome of this will be advised on this ANZTPA.org site, on the Medsafe website and on the Therapeutic Goods Administration website as soon as possible. Implementation of the changes is expected to commence in both countries by the end of April 2013.

Questions relating to submissions

In Australia

Any questions relating to submissions should be directed to the OTC Medicines Business Process Reform, via email to OTCBPRconsultationpaper@tga.gov.au.

In New Zealand

Any questions relating to submissions should be directed to the Manager Product Regulation, via email to medsafeapplications@medsafe.govt.nz.

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