Recommendation 2 If the National Co-ordinating Committee on Therapeutic Goods (NCCTG) is disbanded, the state and territory regulators and the Secretary, through the Australian Health Ministers’ Advisory Council (AHMAC), should establish a mechanism for policy oversight. This should include the development and on-going maintenance of the SPF and other guidelines relevant under s52E(2) of the TG Act. Recommendation 3 Through the mechanism referred to in Recommendation 2, consider the findings of this report to: determine the level of detail required in the SPF regarding the matters the Secretary must take into account when exercising powers determine whether additional decision-making principles (outlining the public health focus of scheduling) should be included in the SPF determine the utility of a more structured approach or framework for risk/benefit assessment (such as that which is currently available for medicines in the UK and under consideration in other countries) consider extending the situations for delegate-only decisions. Consider circumstances where the Australian Pesticides and Veterinary Medicines Authority (APVMA) can provide scheduling recommendations for agricultural and veterinary chemicals directly to the Secretary or delegate. Consider circumstances in which the APVMA can decide not to refer agricultural or veterinary chemicals to the Secretary or delegate, if the recommendation would only be to confirm an existing schedule listing develop a process to reject or defer consideration of applications which do not meet application requirements, or are deficient in data clarify the scope of the to include the ability to term ‘amend’; ‘delete’; listed substances from the Poisons Standard. Recommendation 4 The secretariat should: publish a document to clarify the application requirements (the by the ‘form approved for all application types Secretary’) review the content and structure of the application template to make it more flexible and easier to use for different application types. In doing so, the secretariat should consider requiring applicants to provide certain information about their application that can be included in public notices. Recommendation 5 The Department of Health and Ageing (DoHA) should give priority to determining business functions and resources of the secretariat- to support a predictable, consistent, timely and effective administration of the scheduling framework.
Recommendation 2 If the National Co-ordinating Committee on Therapeutic Goods (NCCTG) is disbanded, the state and territory regulators and the Secretary, through the Australian Health Ministers’ Advisory Council (AHMAC), should establish a mechanism for policy oversight. This should include the development and on-going maintenance of the SPF and other guidelines relevant under s52E(2) of the TG Act. Recommendation 3 Through the mechanism referred to in Recommendation 2, consider the findings of this report to: determine the level of detail required in the SPF regarding the matters the Secretary must take into account when exercising powers determine whether additional decision-making principles (outlining the public health focus of scheduling) should be included in the SPF determine the utility of a more structured approach or framework for risk/benefit assessment (such as that which is currently available for medicines in the UK and under consideration in other countries) consider extending the situations for delegate-only decisions. Consider circumstances where the Australian Pesticides and Veterinary Medicines Authority (APVMA) can provide scheduling recommendations for agricultural and veterinary chemicals directly to the Secretary or delegate. Consider circumstances in which the APVMA can decide not to refer agricultural or veterinary chemicals to the Secretary or delegate, if the recommendation would only be to confirm an existing schedule listing develop a process to reject or defer consideration of applications which do not meet application requirements, or are deficient in data clarify the scope of the term ‘amend’; to include the ability to ‘delete’; listed substances from the Poisons Standard. Recommendation 4 The secretariat should: publish a document to clarify the application requirements (the ‘form approved by the Secretary’) for all application types review the content and structure of the application template to make it more flexible and easier to use for different application types. In doing so, the secretariat should consider requiring applicants to provide certain information about their application that can be included in public notices. Recommendation 5 The Department of Health and Ageing (DoHA) should give priority to determining business functions and resources of the secretariat- to support a predictable, consistent, timely and effective administration of the scheduling framework.