RIS: evidence to support new While the RIS identified Evidence from literature has requirements specific concerns with current been relied upon to support labelling practices, a number objectives of the labelling of respondents from both the review, where available. health professions and Literature in Australia on the industry considered that it did true extent of the problem not provide a good level of attributed solely to labelling evidence that the proposed and packaging is limited. actions would deliver the Therefore, much of the overall desired level of evidence outlined in the RIS improvement in public health comes from overseas. and safety. Comments particularly applied to low risk, non-prescription products. The comments also drew on the lack of good base level data and the absence of an evaluation plan. RIS: risk based approach Feedback noted that the draft Implementing a risk-based (proportionate response) TGO 79 presented a ‘one size approach would be too fits all’ approach and did not difficult to define in a labelling adequately differentiate Order. Specific issues of this requirements on the basis of nature would not be dealt the risk. Many respondents with through a labelling Order identified problem products, update. For example, for a such as those containing particular active ingredient, paracetamol and ibuprofen, issues of this nature can be and considered that their risks addressed by applying specific should be directly addressed, or listing to particular classes rather than imposing of goods. requirements on all medicines Consideration is being given in a particular category. to issues raised on a basis. For example the split between prescription and non-prescription medicines has led to greater differentiation between the types of goods (low risk vs higher risk registered goods). This can be seen through exemption for medicine information panel (now called the display of ‘critical health information’) for low risk products.
RIS: evidence to support new requirements While the RIS identified specific concerns with current labelling practices, a number of respondents from both the health professions and industry considered that it did not provide a good level of evidence that the proposed actions would deliver the overall desired level of improvement in public health and safety. Comments particularly applied to low risk, non-prescription products. The comments also drew on the lack of good base level data and the absence of an evaluation plan. Evidence from literature has been relied upon to support objectives of the labelling review, where available. Literature in Australia on the true extent of the problem attributed solely to labelling and packaging is limited. Therefore, much of the evidence outlined in the RIS comes from overseas. RIS: risk based approach (proportionate response) Feedback noted that the draft TGO 79 presented a ‘one size fits all’ approach and did not adequately differentiate requirements on the basis of the risk. Many respondents identified problem products, such as those containing paracetamol and ibuprofen, and considered that their risks should be directly addressed, rather than imposing requirements on all medicines in a particular category. Implementing a risk-based approach would be too difficult to define in a labelling Order. Specific issues of this nature would not be dealt with through a labelling Order update. For example, for a particular active ingredient, issues of this nature can be addressed by applying specific or listing to particular classes of goods. Consideration is being given to issues raised on a basis. For example the split between prescription and non-prescription medicines has led to greater differentiation between the types of goods (low risk vs higher risk registered goods). This can be seen through exemption for medicine information panel (now called the display of ‘critical health information’) for low risk products.
General-requirements-for-labels-for-medicines-RIS.docx