2 Amendments of Piernicola PEDICINI related to 2014/0256(COD)
Amendment 18 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) The Commission should be able to include, in its general report on the experience acquired as a result of the application of the procedures laid down in this Regulation, information concerning a proposal to revise Council Regulation No (EC) 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products;
Amendment 52 #
Proposal for a regulation
Article 1 – point 18
Article 1 – point 18
Regulation (EC) No 726/2004
Article 86
Article 86
At least every tenfive years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation and in Chapter 4 of Title III of Directive 2001/83/EC. In the general report the Commission may include information concerning a proposal to revise Council Regulation No (EC) 297/95.