Judgment_paragraph 66 · Novartis Europharm Ltd v European Commission (C-629/15 P, C-630/15 P)

66It must be noted that the terms ‘any variations and extensions’ in the second subparagraph of Article 6(1) of Directive 2001/83 actually refer to a ‘variation to the terms of [an MA]’ or an ‘extension of [an MA]’, within the meaning of Regulation No 1085/2003, applicable in the present cases. Those variations amount precisely to ‘includ[ing] in the initial [MA]’ the developments concerned and must therefore be regarded as forming part of the ‘global marketing authorisation’.

Novartis Europharm Ltd v European Commission (C-629/15 P, C-630/15 P)

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