Revised: 18 April 2013


New approach to evaluation of over the counter medicines in Australia and New Zealand

18 April 2013
Hon Tony Ryall
Minister of Health

A new streamlined process for assessing medicines sold over the counter takes effect this week marking a major step towards establishing a single Trans-Tasman regulatory agency for therapeutic products.

New Zealand Health Minister Tony Ryall and Australian Parliamentary Secretary for Health and Ageing, Shayne Neumann made the announcement today.

"For the past 18 months regulators, industry and consumers on both sides of the Tasman have been working together to streamline and harmonise processes for approvals for over-the-counter (OTC) medicines,” Mr Ryall said.

“The common approach to processing applications for medicines sold over the counter signals a significant step towards establishing the new agency."

“These reforms introduce more predictability for companies wishing to supply OTC medicines in Australia and New Zealand,” Mr Neumann said.

“The new processes are largely administrative but will lead to greater transparency and a faster process without compromising the level of scrutiny applied to ensure OTC medicines meet the exacting standards expected by all consumers.”

The new processes will be rolled out over the next 12 months. More information is available on the TGA, Medsafe and ANZTPA websites.

Other progress towards the joint Australian and New Zealand Therapeutic Products Agency includes:

  • Established a Joint Adverse Events Notification System for medicines (JAENS-Medicines) giving people access online to adverse events associated with medicines in Australia and New Zealand.
  • Finalising plans for a Trans-Tasman early warning system which will alert health professionals and consumers to safety concerns identified with medicines and medical devices. This is scheduled to be launched later this year.
  • A recall portal to advise consumers and health professionals about recalls of therapeutic products.


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