Judgment_paragraph 11 · Staat der Nederlanden v Warner-Lambert Company LLC (C-423/17)

11Article 4(1) of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ 2008 L 334, p. 7), as amended by Commission Regulation (EU) No 712/2012 of 3 August 2012 (OJ 2012 L 209, p. 4) (‘Regulation No 1234/2008’), provides that the European Commission is to draw up 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 that regulation, as well as on the documentation to be submitted pursuant to those procedures.

Staat der Nederlanden v Warner-Lambert Company LLC (C-423/17)

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