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OTC medicines: guidelines and processes update 2013: Information for consumers

22 March 2013
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On 15 April 2013, the TGA and Medsafe 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.

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

  • Pharmacy Medicines (available from a pharmacy without a prescription); or
  • Pharmacist-Only Medicines (available from a pharmacist without a prescription); or
  • General sales medicines (freely available from both pharmacies and other retail outlets).

Most OTC medicines regulated by the TGA have an AUST R number on the container.

AUST R is explained in Medicines and TGA classifications.

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.
The implementation of new processes and guidelines will be launched on 15 April 2013. The regulators have put in place a 12 transition period to allow the regulated industry to transition to this new approach.
The TGA and Medsafe want to improve their processes to deliver a more efficient and effective process for suppliers of OTC medicines in Australia and New Zealand.
The new streamlined processes will ensure that customers continue to have timely access to safe and effective OTC medicines.
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 the TGA or Medsafe before 15 April 2013 can still be used as long as they have not passed their use by date and have been stored correctly.
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.