43Finally, and for the same reasons as those set out by the Advocate General in his Opinion, the Court must reject the arguments of SmithKline Beecham and the United Kingdom Government based, respectively, on:— the definition of ‘qualitative composition’ of a medicinal product given in the Annex to Directive 75/318, implying that the active ingredient should be understood, in the case of salts, to include both the therapeutic moiety and the appended portion of the molecule, and should be identified as such (see point 80 of the Opinion);— the reference made to Commission Regulation (EC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State (OJ 1995 L 55, p. 7), Annex II of which requires that a new MA be applied for in the event of ‘changes to the active substance(s)’, which, according to that Annex, includes ‘replacement of the active substance(s) by a different salt ... (with the same therapeutic moiety)’ (paragraph 82);— definitions contained in Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ (OJ 2000 L 103, p. 5) (paragraphs 85 to 89).
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