1 Amendments of Carl SCHLYTER related to 2008/0045(COD)
Amendment 25 #
Proposal for a directive – amending act
Article 2 – point 1 a (new)
Article 2 – point 1 a (new)
Directive 2001/83/EC
Article 23 c (new)
Article 23 c (new)
(1a) The following Article 23c is inserted: The appropriate arrangements adopted by the Commission must take the following considerations into account: – For practical reasons of efficiency, the possibility should be extended to all the categories of change of submitting a single application for one or more identical changes made to the terms of a number of marketing authorisations; – Without prejudice to the global marketing authorisation referred to in Article 6(1), in the framework of extensions of marketing authorisations, the possibility should be provided, on the basis of arguments in justification, of submitting a complete, separate application for authorisation for a medicinal product that has already been authorised under another name and with a different product characteristic summary.”