Revised: 25 March 2013

OTC medicines: Guidelines and processes update 2013

On 15 April 2013 Medsafe and the TGA will commence the introduction of new administrative procedures for the processing of new and changed over-the-counter (OTC) medicine applications.

These changes are administrative in nature, and the regulators will continue to apply stringent levels of scrutiny. Be reassured that OTC medicines will continue to go through the appropriate level of evaluation for safety, efficacy and quality by the regulators.

What is an OTC medicine?

OTC medicines are medicines that are not prescription medicines and are not complementary medicines. OTC medicines can be supplied as:

How can I tell whether an OTC medicine is regulated by Medsafe?

Medsafe maintains a database of medicines that have been approved for sale in New Zealand. You can search for approved medicines using either the brand name or the ingredient name.

What is changing about OTC medicines regulation?

New processes and guidelines are being introduced to deliver shorter and more predictable times to market for OTC medicines. You can read about what is changing in the OTC medicines: guidelines and processes update 2013: Information for industry.

When will the change happen?

The implementation of new processes and guidelines will be launched on 15 April 2013. The regulators have put in place a 12 month transition period to allow the regulated industry to transition to this new approach.

Why is this change happening?

Medsafe and the TGA want to improve their processes to deliver a more efficient and effective process for suppliers of OTC medicines in Australia and New Zealand.

What is the benefit to me?

The new streamlined processes will ensure that customers continue to have timely access to safe and effective OTC medicines.

Should I stop using or throw out OTC medicines which went through the old regulatory process?

No. The new process only affects administrative procedures used by the regulator. There are no changes to the standards which OTC medicines must meet before being marketed in Australia or New Zealand. OTC medicines were approved by Medsafe and the TGA before 15 April 2013 can still be used as long as they have not passed their use by date and have been stored correctly.

Will I be able to continue buying OTC products that went through the old process?

Yes. All OTC products that were approved before 15 April 2013 will still be allowed to be manufactured and sold in Australia and New Zealand.