Revised: 2 July 2013


New Amendments to the Medicines Regulations 1984

The Medicines Amendment Regulations 2011 were gazetted on 14 July 2011 and are available on the Government's Legislation website ( With the exception of those regulations relating to aligning prescribing and the form of a prescription, the changes come into effect on 1 August 2011. The remaining changes will come into effect on 1 December 2011, allowing time for the necessary changes to be made to prescribing software.

The amendments include:

  • Changes to some definitions relating to pharmacy qualifications
  • Changes to advertising and labelling requirements, bringing them into closer alignment with Australian requirements
  • Changes to the rules relating to prescribing and dispensing medicines, including alignment of prescribing provisions for different prescriber groups, provision for generic substitution by pharmacists, and updates to the requirements for prescriptions
  • Updates to the requirements for data sheets
  • Exclusion of certain products (e.g. some fluoride toothpastes, anti-dandruff preparations) from regulation under the Medicines Act 1981
  • Provision for an approval to be granted for sale of general sale medicines by means of a vending machine

NOTE: The proposal to extend the period of supply on a prescription is NOT being progressed at this time. The maximum period of supply remains at 6 months for oral contraceptives and 3 months for all other prescription medicines.


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