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Labelling Project 99/00 PO Box 100 Woden ACT 2606 Australia Telephone: (02) 6232 8444 Facsimile: (02) 6232 8241 Labelling project 99/00 Effective by design A discussion paper on possible reforms to the regulation of the labelling of medicines in Australia April 2000 ii You are invited to comment All interested parties are invited to respond to this paper. Specific questions and recommendations are placed within the text as a guide for responses. However, while answers to these will be helpful to us, your responses do not have to be restricted by these. Please send submissions to: Labelling Project 99/00 Review of Drugs and Poisons Legislation Branch (MDP88) PO Box 100 WODEN ACT 2606 Submissions will normally be regarded as public documents. If you wish any material to remain confidential, please identify this material and provided the basis for its confidential nature. Because comments on the matter of moving warnings on medicine labels out of the Standard for the Uniform Scheduling of Drugs and Poisons is required to feed into the Review of Drugs, Poisons and Controlled Substances Legislation, but stakeholders may need more time to consider the other issues, it is necessary to split the comments deadline dates. Closing dates for submissions: Friday 26 May 2000 for comments on SUSDP warnings movement to therapeutic goods legislation Friday 23 June 2000 for comments on the paper as a whole i ii Contents You are invited to comment .................................................................. i Summary ..................................................................................... vi Issues ............................................................................................................................................................................vi Proposals...................................................................................................................................................................... xi Introduction...................................................................................1 Why are we doing this project?.......................................................................................................................... 1 What is involved in undertaking the project?............................................................................................... 1 What can I expect in reading this paper?......................................................................................................2 1 Why is there a need for change? ........................................... 3 Problems and concurrent change ........................................................................................................................4 The asymmetry of information for consumers.............................................................................................5 Prescription medicine issues.................................................................................................................................5 Prescriptive or performance-based regulation for sponsor labels......................................................6 Advertising changes .................................................................................................................................................6 International issues..................................................................................................................................................7 Warnings........................................................................................................................................................................7 2 Proposals....................................................................... 9 2.1 Basis for a new model for regulation of labelling..................................... 10 Maxims .........................................................................................................................................................................10 Regulatory tools.......................................................................................................................................................10 2.2 Warnings from the Standard for the Uniform Scheduling of Drugs and Poisons.... 11 Does this address the issues? ...........................................................................................................................12 2.3 What would performance-based regulation look like? ................................ 12 Statement of performance required..............................................................................................................12 Performance standard...........................................................................................................................................13 Guidelines....................................................................................................................................................................14 Code of practice for the testing of label performance.........................................................................15 2.4 Do we need to mandate elements of more effective communication for non- prescription medicines?..................................................................... 15 2.5 What improvements for labelling of prescription medicines are required?........... 17 Sponsor label .............................................................................................................................................................17 Dispenser label (regulated under State and Territory laws) ..............................................................17 Hospital/professional user (regulated under State and territory laws)........................................18 2.6 Putting it together..................................................................... 18 How can we integrate performance-based regulation with the need for taking all warnings and the needs for the different categories of medicines?..................................................................18 1 Scope.........................................................................................................................................................................18 2.7 What would this mean for the different categories of medicines?.................. 20 Recommended proposal ..................................................................... 22 3 Issues and concepts ......................................................... 25 3.1 The policy environment................................................................. 26 The National Competition Policy......................................................................................................................26 iii Best practice in standards setting and development of regulations...............................................26 Safety and quality use objective.....................................................................................................................28 National Medicinal Drug Policy.........................................................................................................................28 3.2 The role of labelling ................................................................... 30 Professional advice .................................................................................................................................................31 Role of the consumer in making decisions based on label information............................................33 3.3 Claims: labelling and advertising....................................................... 35 Current system........................................................................................................................................................36 Proposed New Code ...............................................................................................................................................37 New system...............................................................................................................................................................37 3.4 Poisons Scheduling ..................................................................... 40 The National Drugs and Poisons Schedule Committee ...........................................................................40 Scheduling process ................................................................................................................................................40 Overlap of TGA and NDPSC................................................................................................................................41 3.5 Harmonisation objectives .............................................................. 42 Reverse scheduling ................................................................................................................................................42 Approved Names.....................................................................................................................................................43 Dietary Supplements in NZ................................................................................................................................43 Other countries.......................................................................................................................................................44 3.6 Implications for the States/Territories .............................................. 46 3.7
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