definiens: ~:MEA " means the European Medicines Evaluation Agem : y and/or the Commlllec for Proprielary Medical Products or any successor agency thereof or, 10 the extent the BE\333384\2 • CONfIOfl'mA1 . llO.u, fl, IEtlr IS ~EQI.Il' . SlUl fOIl ; TIlE LAI'fGUAO ! : _ ICH ItA5 BU, ., ' LA.CEO IN IlMCKFTS SlCIl LAN(A1AOe llAS III lJo / OF.I.I.'ED FIIOM Tlt~ COf'V FIU :O WlTII Tllt . S1'C 4 CONflO.;N1·IAl . ' l'REATl\II<:NT ItEQIJ ..... /·m1l > mutual rcooglUtion procedure IS used for the Product in the EU, any govemmcntal autbonly having the authority to regulate the sale of medicmal or phanllaetutlcal products in any counlry in the EU