Revised: 25 March 2013

OTC medicines: guidelines and processes update 2013

What should I tell my patients or customers about the new over-the-counter (OTC) medicine evaluation process?

There are no changes to standards employed by the regulator for assessing the benefits and risks posed by new and changed OTC medicines.

The new process applies to administrative procedures only.  There will be no change to the supply of new OTC medicines on the Australian and New Zealand markets.

When will I be able to provide OTC medicines to my patients and customers that have been assessed as part of this new process?

OTC medicines that have been assessed as part of this new process will gradually appear on the market over the coming few years, commencing in about 6 months time. 

Will I still be able to sell or recommend OTC products that were evaluated under the old system?

Yes. Existing OTC medicines that were approved prior to 15 April 2013 can still be supplied in accordance with the conditions of approval.  The implementation of new administrative procedures does not affect the safety, efficacy or quality standards against which OTC medicines are assessed.