Category 2: those that would make a normal business change in the fifth year, but bring forward that change to comply with the four year transition, 15 per cent of 15800 Category 3: those that would not make a change, the remaining 10 per cent. Category 2 annual costs over 10 years are $0.42 million per annum. Category 3 annual over 10 years are $0.28 million per annum. Total costs per year over 10 years for this option are $0.7 million per annum. The costs to make changes to a label with regard to pre-production and post-production costs has been provided through industry consultation and reflect an average of costs provided to an independent reviewer from 9 prescription, OTC and complementary medicines sponsors. Regulatory Burden and Cost Offset Estimate Table Average Annual Regulatory Costs (from Business as usual) Change in costs Business Community Individuals change ($million) Organisations in cost Option 2 $0.2 $0.2 Option 3 (a) $3 $3 Option 3 (b) $1.7 $1.7 Option 3 (c) $0.7 $0.7 by Sector $ $ $ $ Cost offset Business Community Individuals by ($million) Organisations Source Electronic $-3 $ $ $-3 Submission of Data Dossiers OBPR ref: 14783 Are all new costs offset? yes, costs are offset no, costs are not offset deregulatory, no offsets required   (Change in costs - Cost offset) ($million) $0
Category 2: those that would make a normal business change in the fifth year, but bring forward that change to comply with the four year transition, 15 per cent of 15800 Category 3: those that would not make a change, the remaining 10 per cent. Category 2 annual costs over 10 years are $0.42 million per annum. Category 3 annual over 10 years are $0.28 million per annum. Total costs per year over 10 years for this option are $0.7 million per annum. The costs to make changes to a label with regard to pre-production and post-production costs has been provided through industry consultation and reflect an average of costs provided to an independent reviewer from 9 prescription, OTC and complementary medicines sponsors. Regulatory Burden and Cost Offset Estimate Table Average Annual Regulatory Costs (from Business as usual) Change in costs ($million) Business Community Organisations Individuals change in cost Option 2 $0.2 $0.2 Option 3 (a) $3 $3 Option 3 (b) $1.7 $1.7 Option 3 (c) $0.7 $0.7 by Sector $ $ $ $ Cost offset ($million) Business Community Organisations Individuals by Source Electronic Submission of Data Dossiers OBPR ref: 14783 $-3 $ $ $-3 Are all new costs offset? yes, costs are offset  no, costs are not offset  deregulatory, no offsets required (Change in costs - Cost offset) ($million) $0
consult-labelling-medicines-140822-ris.docx