24/04/2003 (Agence Europe) - The European Commission has finally just adopted its amended draft directive on medicines for human consumption. The Commission has accepted a certain number of amendments adopted by the European Parliament in October's first reading, like, for example, the re-evaluation of full market approval after five years (in its initial proposal the first authorisation was definitive). On the other hand, the Commission maintains the ten years protection for clinical data, with the possibility of an additional one year extension in cases of new therapeutic indications. It does not accept the Parliament's amendments that would allow manufacturers of generics to begin seeking full market approval before the expiry of this deadline. EUROPE points our that Greek Presidency intends to reach a political agreement on the Medicines package during the Social Affairs/health Council session on 2-3 June in Luxembourg.