1 Amendments of Edite ESTRELA related to 2008/0045(COD)
Amendment 21 #
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: “Article 23c 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; – In the framework of extensions of marketing authorisations, the possibility should continue to 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. Nevertheless, that application shall be subject to the marketing authorisation procedure provided for in Article 6(1).”