- has already been granted, as a medicinal product, a Community marketing authorisation in accordance with Council Regulation (EEC) No 2309/93 (*) or Regulation(EC) No 726/2004;
– kas jau saņēmusi Kopienas zāļu tirdzniecības atļauju saskaņā ar Padomes Regulu (EEK) Nr. 2309/93 (*) vai Regulu (EK) Nr. 726/2004