Table 6: Summary and Response to 2014 public consultation Issue Comment Response from TGA Policy options Option 3 (regulatory option) The RIS and draft TGO 79 have was the predominant choice been revised. amongst stakeholders. There While a 2-year transition was a clear message that the period would be optimal for RIS and the draft TGO 79 both objectives of the review required revision and then including quick uptake and further amendment and benefits to be realised, the consultation prior to any cost to implement is too high. implementation. A 4-year transition period Option 2 (guidance) was not more closely aligns with preferred on the basis of typical business as usual potential lack of compliance, activities for the therapeutic while Option 1 (status quo) goods industry. was seen as not addressing the issues which are overall A 4-year transition period has well recognised and been chosen to minimise costs understood by stakeholders. and align with IHIN transition period. During IHIN Industry preference was for a consultation, some 4-year implementation (or stakeholders indicated that a longer) while health shorter transition period professionals and consumer could lead to a disruption in representation preferred the the supply chain for products 2-year implementation option. that have a short shelf life and potentially result in medicine shortages and risks to public health. If there are specific safety issues with particular types of goods, these can be dealt with through, for example, amendments to the Required Advisory Statement for Medicine Labels for medicines or through of registration or listing.
Table 6: Summary and Response to 2014 public consultation Issue Comment Response from TGA Policy options Option 3 (regulatory option) was the predominant choice amongst stakeholders. There was a clear message that the RIS and the draft TGO 79 both required revision and then further amendment and consultation prior to any implementation. Option 2 (guidance) was not preferred on the basis of potential lack of compliance, while Option 1 (status quo) was seen as not addressing the issues which are overall well recognised and understood by stakeholders. Industry preference was for a 4-year implementation (or longer) while health professionals and consumer representation preferred the 2-year implementation option. The RIS and draft TGO 79 have been revised. While a 2-year transition period would be optimal for objectives of the review including quick uptake and benefits to be realised, the cost to implement is too high. A 4-year transition period more closely aligns with typical business as usual activities for the therapeutic goods industry. A 4-year transition period has been chosen to minimise costs and align with IHIN transition period. During IHIN consultation, some stakeholders indicated that a shorter transition period could lead to a disruption in the supply chain for products that have a short shelf life and potentially result in medicine shortages and risks to public health. If there are specific safety issues with particular types of goods, these can be dealt with through, for example, amendments to the Required Advisory Statement for Medicine Labels for medicines or through of registration or listing.
General-requirements-for-labels-for-medicines-RIS.docx