ker Direktiva Sveta 93/39/EGS z dne 14. junija 1993, ki spreminja Direktive 65/65/EGS, 75/318/EGS in 75/319/EGS v zvezi z zdravili 1, določa, da se ob nesoglasju med državami članicami o kakovosti, varnosti ali učinkovitosti zdravila, za katero velja decentralizirani odobritveni postopek Skupnosti, zadeva razreši z zavezujočo odločbo Skupnosti, ki sledi znanstveni oceni vključenih vprašanj, ki se opravi v Evropski agenciji za vrednotenje zdravil;
Whereas Council Directive 93/39/EEC of 14 June 1993 amending Directive 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products (9) has provided that in the event of a disagreement between Member States about the quality, safety or efficacy of a medicinal product which is the subject of the decentralized Community authorization procedure, the matter should be resolved by a binding Community decision following a scientific evaluation of the issues involved within a European medicinal product evaluation agency;