Implementation of the permitted indications list 4.3 Is Option 2 for selecting indications for inclusion on the ARTG and on product labels and promotional material suitable to address the objectives for permitted indications? 4.4 What other considerations should be taken into account in implementing the permitted indications list? Additional requirements for the use of permitted indications As well as specifying permitted indications, the list will also include requirements in relation to some indications. The purpose of imposing a requirement for a permitted indication is to ensure that the indication is suitable for use in medicines that have not been pre- market assessed. The requirements may specify circumstances when the indication can or cannot be used or specify conditions that must be met. These requirements will be consistent with the current regulatory framework. For example, a requirement might: specify a target population for the indication is not suitable, such as children require a label warning statement, such as: where an indication refers to the signs and symptoms of a disease, there may be a requirement to include a label warning statement, with words to the effect of: symptoms persist consult your healthcare practitioner’. ‘If 5. Claiming evidence of efficacy Overview The Panel recommended that following pre-market efficacy assessment by the TGA, sponsors should be able to claim that the product’s efficacy has been assessed for the indication(s) (use a In supporting this recommendation, the Government identified ‘claimer’). the need to carefully consider the design and use of these statements. Use of a claimer will allow complementary medicines that have had their efficacy assessed to differentiate themselves in the market. It may also improve consumer awareness of the different levels of assessment of complementary medicines undertaken by the TGA and encourage use of the new assessment pathway for products carrying intermediate level indications. Criteria for use of ‘claimers’ In implementing the ability for sponsors to that the efficacy of their product has been assessed, the following criteria are proposed: A claimer will be approved for: complementary medicines evaluated by the TGA via the new pathway
Implementation of the permitted indications list 4.3 Is Option 2 for selecting indications for inclusion on the ARTG and on product labels and promotional material suitable to address the objectives for permitted indications? 4.4 What other considerations should be taken into account in implementing the permitted indications list? Additional requirements for the use of permitted indications As well as specifying permitted indications, the list will also include requirements in relation to some indications. The purpose of imposing a requirement for a permitted indication is to ensure that the indication is suitable for use in medicines that have not been pre- market assessed. The requirements may specify circumstances when the indication can or cannot be used or specify conditions that must be met. These requirements will be consistent with the current regulatory framework. For example, a requirement might: specify a target population for the indication is not suitable, such as children require a label warning statement, such as: where an indication refers to the signs and symptoms of a disease, there may be a requirement to include a label warning statement, with words to the effect of: ‘If symptoms persist consult your healthcare practitioner’. 5. Claiming evidence of efficacy Overview The Panel recommended that following pre-market efficacy assessment by the TGA, sponsors should be able to claim that the product’s efficacy has been assessed for the indication(s) (use a ‘claimer’). In supporting this recommendation, the Government identified the need to carefully consider the design and use of these statements. Use of a claimer will allow complementary medicines that have had their efficacy assessed to differentiate themselves in the market. It may also improve consumer awareness of the different levels of assessment of complementary medicines undertaken by the TGA and encourage use of the new assessment pathway for products carrying intermediate level indications. Criteria for use of ‘claimers’ In implementing the ability for sponsors to that the efficacy of their product has been assessed, the following criteria are proposed: A claimer will be approved for: complementary medicines evaluated by the TGA via the new pathway