Proposal for a directive – amending act
Article 2 – point 1 a (new)
Directive 2001/83/EC
Article 23 c (new)
1 Notice to Applicants, VOLUME 2A Procedures for marketing authorisation; CHAPTER 1 MARKETING AUTHORISATION, point 7.2 page 35, November 2005(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 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, this application will be regarded as belonging to the same global marketing authorisation defined in Article 6(1).” Or. en