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EC: Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to

06.06.2013
These guidelines apply to the variations of marketing authorisations for medicinal products for human use and veterinary medicinal produ cts granted in accordance with Regulation 726/2004, Directive 2001/82, Directive 2001/83 and Council Directive 87/223. They are intended to facilitate the interpretation and application of the Variations Regulation. They provide details on the application of the relevant procedures, including a description of all the relevant steps from the submission of an application for a variation to the final outcome of the procedure on the application.