Reg.C229/03EEC中提到As stated before, for an abridged application concerning a medicinal product essentially similar to one already covered by a Community authorisation, the centralised route must be used in all cases. Therefore generic applications referring to Community marketing authorisation dossier for medicinal products which are essentially similar to Community authorised products falling under the scope of Part B of the Annex to Regulation (EEC) No 2309/93, must follow the centralised procedure。
再查看Part B of the Annex to Regulation (EEC) No 2309/93中有一条为Medicinal products intended for administration to human beings, containing a new active substance which, on the date of entry into force of this Regulation, was not authorized by any Member State for use in a medicinal product intended for human use，我的理解为新药对吧？这两则条款结合起来，是不是可以理解为如果原研药采用集中审批途径，我仿制药也一定要采用集中申报途径？
但是(EC) No 726/2004 Article 3(3)： A generic medicinal product of a reference medicinal product authorised by the Community may be authorised by the competent authorities of the Member States in accordance with Directive 2001/83/EC and Directive 2001/82/EC under the following conditions：(a) the application for authorisation is submitted in accordance with Article 10 of Directive 2001/83/EC or Article 13 of Directive 2001/82/EC，这里明显就是说原研是集中审批程序，仿制药也可以选择成员国审批程序，和上面矛盾了。求专家指点，谢谢