errors resulting from the Ozurdex brand name is minimal.” The RMP Questions and The sponsor states: Table 3–1: Answers (Version 1.3, October assessor’s “The ‘Differences 2012) as found on the TGA observation has been between the risk website state: ASA should addressed and a table minimisation “The identify any differences listing risk activities between the EU RMP and the minimisation undertaken as local implementation of risk activities undertaken reflected in the management activities, for as reflected in the content of the example: any differences content of the EU EU SmPC and between the risk minimisation SmPC and the the proposed activities undertaken as proposed Australian Australian PI’ of reflected in the content of the PI for all of the the ASA does not EU SmPC and the proposed specified ongoing specifically Australian PI, and the reasons safety concerns and identify and for the difference.” missing information provide reasons Consequently the ASA should has now been for any observed be revised to include a risk included in Section differences. For minimisation activities table 3.0 of ASA v2.0 based example for the detailing all planned risk on the EMA approved important minimisation measures in the EU RMP v7.0.” identified risk: Australian context and the EU IOP, ‘Increased RMP context. This table should Glaucoma, include a comparison of the Ocular actual content and wording of Hypertension’, the EU SmPC and the proposed Section 4.4 of Australian PI and CMI for all of the SmPC states the specified ongoing safety that patients concerns and missing should be information to identify and monitored provide reasons for any following the observed differences; injection to particularly where it appears permit early the EU SmPC is more treatment if an restrictive. Upon receipt of infection or such information increased IOP recommendations to the occurs and such Delegate in regard to the monitoring may proposed routine risk consist of a minimisation activities can check for then be made. Such a table perfusion of the should also definitively optic nerve head indicate whether additional immediately risk minimisation in the form after the of prescriber educational injection, material is proposed for all the tonometry specified important identified within 30 risks and patient educational minutes material is proposed for the following the important identified risks: injection, and intraocular biomicroscopy ‘Increased
errors resulting from the Ozurdex brand name is minimal.” The RMP Questions and Answers (Version 1.3, October 2012) as found on the TGA website 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 SmPC and the proposed Australian PI, and the reasons for the difference.” Consequently the ASA should be revised to include a risk minimisation activities table detailing all planned risk minimisation measures in the Australian context and the EU RMP context. This table should include a comparison of the actual content and wording of the EU SmPC and the proposed Australian PI and CMI for all of the specified ongoing safety concerns and missing information to identify and provide reasons for any observed differences; particularly where it appears the EU SmPC is more restrictive. Upon receipt of such information recommendations to the Delegate in regard to the proposed routine risk minimisation activities can then be made. Such a table should also definitively indicate whether additional risk minimisation in the form of prescriber educational material is proposed for all the specified important identified risks and patient educational material is proposed for the important identified risks: ‘Increased intraocular The sponsor states: “The assessor’s observation has been addressed and a table listing risk minimisation activities undertaken as reflected in the content of the EU SmPC and the proposed Australian PI for all of the specified ongoing safety concerns and missing information has now been included in Section 3.0 of ASA v2.0 based on the EMA approved EU RMP v7.0.” Table 3–1: ‘Differences between the risk minimisation activities undertaken as reflected in the content of the EU SmPC and the proposed Australian PI’ of the ASA does not specifically identify and provide reasons for any observed differences. For example for the important identified risk: ‘Increased IOP, Glaucoma, Ocular Hypertension’, Section 4.4 of the SmPC states that patients should be monitored following the injection to permit early treatment if an infection or increased IOP occurs and such monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy