Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p2
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 3253–6868

until 30 April 2028.44
Part 3—Dual labelling name.........................................45
Schedule 3........................................................46
Specified neuromuscular blocking agents (or salts thereof)...............46
Endnotes..............................................................48
Endnote 1—About the endnotes........................................48
Endnote 2—Abbreviation key..........................................49
Endnote 3—Legislation history.........................................50
Endnote 4—Amendment history........................................51

     Introduction

      1.            This Order sets out what kinds of information are required to be included on the label of prescription and other related medicines of the kind described in section 3, and in what circumstances.
      2.            The purpose of the label on a medicine is to provide information about the medicine such as its identity, potency, content, storage, expiry date, dose, directions for use, sponsor details and registration status.  Labels on medicines can also include other information not required by this Order but which may be required by other legislation or for commercial purposes, such as the sponsor's logo.
      3.            The information included on a label contributes to the quality use of medicines.  Quality use of medicines means selecting management options wisely, choosing suitable medicines if a medicine is considered necessary, and using those medicines safely and effectively.
      4.            The requirements set out in this Order are consistent with the National Medicines Policy which aims to meet medication and related service needs, so that both optimal health outcomes and economic objectives are achieved. The four central objectives of the policy are:

         * timely access to the medicines that Australians need, at a cost individuals and the community can afford;
         * medicines meeting appropriate standards of quality, safety and efficacy;
         * quality use of medicines; and
         * maintaining a responsible and viable medicines industry.

      1.            This Order also sets out general requirements for the labels of prescription and related medicines.  The purpose of the Order is to facilitate the quality use of those medicines by consumers and health professionals by ensuring appropriate labelling.  Consideration of the following objectives in designing labels, and assessing and determining compliance with the requirements of this Order, will assist in achieving that purpose:

         * minimising the risk of prescribing and dispensing errors;

         * enhancing consumer safety;

         * avoiding consumer confusion and the inappropriate use of medicines (including misuse, over-use, and under-use);

         * assisting the appropriate selection of those medicines;

         * assisting the safe and effective use of those medicines;

         * optimising identification and usability of necessary information;

         * improving consumers' ability to solve problems related to those medicines, such as managing multiple medicines; and

         * where relevant, ensuring consumers are aware of where to go for further information about their medicine.

      1.   Guidelines to assist in the design of medicine labels are available on the Therapeutic Goods Administration website (http://www.tga.gov.au).
      2.            Under the Act:

         * whether a medicine conforms to a standard applicable to the medicine is a matter the Secretary must take into account