definiens: shall mean with respect to a product ( a ) for eachcountry in the European Union, ( i ) the Summary of Product Characteristics ( as required by the Directive ), ( ii ) anydisplay of written, printed or graphic matter upon the immediate container, outside container, wrapper or otherpackaging of a product ( including any pricing and reimbursement information and other local information containedwithin the on the packaging of such product that is not included in the EU annexes attached to theEuropean Commission ’s Decision with respect to the approval of such product ) or ( iii ) any written, printed or graphicmaterial on or within the package from which a product is to be dispensed, including the Package Leaflet ( as requiredby the Directive ), in each case ( ( i ) through ( iii ) ), as approved by the European Commission or ( b ) for each of the OtherEuropean Countries, the equivalent of each of the foregoing in such country, in each case, as approved by theapplicable Regulatory Authority