2012) as found on the states: ASA, has any differences between ‘The TGA website, when an been updated to the content and wording existing European Union incorporate the RMP of the EU SmPC and the (EU) RMP is available, evaluator’s proposed Australian PI the TGA strongly recommendations.’ for all of the specified recommends submission ongoing safety concerns of the EU-RMP with an has been provided in the ASA. These guidelines updated ASA. Therefore also state: ASA this issue remains ‘The should identify any outstanding and should differences between the be adequately addressed EU-RMP and the local before this application is implementation of risk approved. management activities, for example: any differences between the risk minimisation activities undertaken as reflected in the content of the EU Summary of Product Characteristics (SmPC) and the proposed Australian PI, and the reasons for the difference.’ Consequently the ASA should be revised to reference the EU-RMP, not the Core RMP. This revision should include identifying and providing reasons for any differences between the EU-RMP and the local implementation of risk management activities in the ASA, for example: any differences between the risk minimisation activities undertaken as reflected in the content of the EU SmPC and the proposed Australian PI. 6. To this end the The sponsor makes no No tabular summary of sponsor should also specific response to this the pharmacovigilance provide a table recommendation, but and risk minimisation summarising the states: Australian activities proposed for ‘The pharmacovigilance plan Specific Annex, has been Australia encompassing and risk minimisation updated to incorporate all of the specified plan proposed for the RMP evaluator’s ongoing safety concerns Australia in the ASA. recommendations.’ has been provided in the Wording pertaining to updated ASA. Therefore
2012) as found on the TGA website, when an existing European Union (EU) RMP is available, the TGA strongly recommends submission of the EU-RMP with an ASA. These guidelines also state: ‘The ASA should identify any differences between the EU-RMP and the local implementation of risk management activities, for example: any differences between the risk minimisation activities undertaken as reflected in the content of the EU Summary of Product Characteristics (SmPC) and the proposed Australian PI, and the reasons for the difference.’ Consequently the ASA should be revised to reference the EU-RMP, not the Core RMP. This revision should include identifying and providing reasons for any differences between the EU-RMP and the local implementation of risk management activities in the ASA, for example: any differences between the risk minimisation activities undertaken as reflected in the content of the EU SmPC and the proposed Australian PI. states: ‘The ASA, has been updated to incorporate the RMP evaluator’s recommendations.’ any differences between the content and wording of the EU SmPC and the proposed Australian PI for all of the specified ongoing safety concerns has been provided in the updated ASA. Therefore this issue remains outstanding and should be adequately addressed before this application is approved. 6. To this end the sponsor should also provide a table summarising the pharmacovigilance plan and risk minimisation plan proposed for Australia in the ASA. Wording pertaining to The sponsor makes no specific response to this recommendation, but states: ‘The Australian Specific Annex, has been updated to incorporate the RMP evaluator’s recommendations.’ No tabular summary of the pharmacovigilance and risk minimisation activities proposed for Australia encompassing all of the specified ongoing safety concerns has been provided in the updated ASA. Therefore