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Item information which requires a distribution for complete approval and assessment must include modification codes regarding the application.

Item information which requires a distribution for complete approval and assessment must include modification codes regarding the application. Submit information for complete evaluation Modifications to PILs such as significant changes to content and/or design and design and must show proceeded conformity with individual screening or bridging data. Modifications to your leaflet in accordance with article 62 (permitting a MA owner to add additional information that is statutory the label plus…