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Review of Interim order applications differs from NDS review in so far as it is based on a balance of risks and benefits. 0 True

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Review of Interim order applications differs from NDS review in so far as it is based on a balance of risks and benefits. 0 True (9 False Interconnectivity and interoperability: Identification of Medicinal Product (IDMP) IDMP is a set of ISO standards that allow for the definition, characterization, and unique and unambiguous identification of pharmaceuticals across the lifecycle from earl development, to authorization, ongoing management and changes and withdrawal. IDMP: Creates common messaging standards for improved IT system communication and prevention of health "data silos" Creates common vocabulary for improved people communication Uniquely and unambiguously identifies drugs across regions & borders\fDivision 8 of the FDR introduced regulatory amendments for a lot by lot release program which applied to all new drugs. 0 True @ False An authorization under the EUNDS regulations is subject to the conditional NOC regulation. O True FalseA variation on the dose of a drug requires the submission of an SNDS. O True O False

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