emergency use; use by veterinarians. Further, some undesirable use of the exemption provisions will continue, potentially undermining the approval process itself (ie, products that would otherwise be submitted for approval will not be submitted), with adverse implications for the overall effectiveness of the regime (access to safe products). Option 1 Retain exemption provisions but Would involve targeted changes to – strengthen. address known issues as identified in the Enhanced status quo with consequential beneficial status quo via For example: effects on health and safety outcomes. updated Emergency use exemption. categories Specification of products Makes for a more complicated scheme (preferred) not needing to be approved. (defining and delimiting the circumstances Continue to permit small- with sufficient precision). scale compounding by pharmacies, but require Would move New Zealand approach on to large-scale compounding to a basis more consistent with international be separately licensed. practice. Require unapproved product to have appropriate supply certification, with attached responsibilities. Other prescribers included (eg, veterinarians). Option 2 An exemption for health In principle, an effective low-cost – professionals acting within regulatory approach. Comprehensive and accountable for their exemption actions. Very different from international practice. Would be used where they May excessive burden for evaluating judge an unapproved product to technical risk issues, and staying be the most appropriate all on therapeutic good developments, things considered. on health professionals. Post-market 12: Monitoring (by the Regulator) Monitoring needs to cover all products and activities where compliance is required, or where there is the potential for risk in terms of safety, quality and efficacy. Information is critical to effective monitoring. The regulator needs to have access to all the necessary information in order to analyse developments and to inform judgments about the nature and level of risks. Current monitoring issues include, for example, whether the regulator:
emergency use; use by veterinarians. Further, some undesirable use of the exemption provisions will continue, potentially undermining the approval process itself (ie, products that would otherwise be submitted for approval will not be submitted), with adverse implications for the overall effectiveness of the regime (access to safe products). Option 1 – Enhanced status quo via updated categories (preferred) Retain exemption provisions but strengthen. For example: Emergency use exemption. Specification of products not needing to be approved. Continue to permit small- scale compounding by pharmacies, but require large-scale compounding to be separately licensed. Require unapproved product to have appropriate supply certification, with attached responsibilities. Other prescribers included (eg, veterinarians). Would involve targeted changes to address known issues as identified in the status quo with consequential beneficial effects on health and safety outcomes. Makes for a more complicated scheme (defining and delimiting the circumstances with sufficient precision). Would move New Zealand approach on to a basis more consistent with international practice. Option 2 – Comprehensive exemption An exemption for health professionals acting within and accountable for their actions. Would be used where they judge an unapproved product to be the most appropriate all things considered. In principle, an effective low-cost regulatory approach. Very different from international practice. May excessive burden for evaluating technical risk issues, and staying on therapeutic good developments, on health professionals. Post-market 12: Monitoring (by the Regulator) Monitoring needs to cover all products and activities where compliance is required, or where there is the potential for risk in terms of safety, quality and efficacy. Information is critical to effective monitoring. The regulator needs to have access to all the necessary information in order to analyse developments and to inform judgments about the nature and level of risks. Current monitoring issues include, for example, whether the regulator:
regulatory-impact-statement-therapeutic-products-regulation.doc.docx