Concerns and Missing Information items in the proposed Australian PI and CMI should be included in the table. How risk minimisation activities will be implemented in Australia suggested – format Safety Concerns Risk minimisation Risk minimisation Differences between or Missing activities activities EU and Australian Information (routine and (routine and activities with additional) proposed additional) proposed justification in the EU RMP for Australia Item 1 Routine activities Routine activities If routine and/or additional activities Include exact wording for Include exact wording differ for Australia EU SmPC statements for Australian PI from that proposed in proposed for this safety statements proposed for the EU RMP, provide concern this safety concern justification for these differences. Additional activities Additional activities Include details of Include details of additional activities to be additional activities to undertaken for this safety be undertaken for this concern in the EU safety concern in Australia. Item 2 … … … Potential for medication errors or other risks if applicable Ensure you include Australian information (if available) on the potential for medication errors or other risks, for example: if an extension of indication or new dosage form is proposed. How risk minimisation activities will be evaluated in Australia. Provide detail about how and when evaluation of additional risk minimisation activities, including educational activities, will be undertaken and reported to the TGA. You must demonstrate that the measures used to mitigate risk are working and, if not, what actions will be taken to ensure effectiveness.
Concerns and Missing Information items in the proposed Australian PI and CMI should be included in the table. How risk minimisation activities will be implemented in Australia – suggested format Safety Concerns or Missing Information Risk minimisation activities (routine and additional) proposed in the EU RMP Risk minimisation activities (routine and additional) proposed for Australia Differences between EU and Australian activities with justification Item 1 Routine activities Include exact wording for EU SmPC statements proposed for this safety concern Routine activities Include exact wording for Australian PI statements proposed for this safety concern If routine and/or additional activities differ for Australia from that proposed in the EU RMP, provide justification for these differences. Additional activities Include details of additional activities to be undertaken for this safety concern in the EU Additional activities Include details of additional activities to be undertaken for this safety concern in Australia. Item 2 … … … Potential for medication errors or other risks if applicable Ensure you include Australian information (if available) on the potential for medication errors or other risks, for example: if an extension of indication or new dosage form is proposed. How risk minimisation activities will be evaluated in Australia. Provide detail about how and when evaluation of additional risk minimisation activities, including educational activities, will be undertaken and reported to the TGA. You must demonstrate that the measures used to mitigate risk are working and, if not, what actions will be taken to ensure effectiveness.
risk-management-plans-australian-specific-annex-template.docx