Judgment_paragraph 14 · European Commission and Others v Pharmaceutical Works Polpharma S.A (C-438/21 P)

14Article 2 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:‘For the purposes of this Regulation, the following definitions shall apply:…4. “Extension of a marketing authorisation” or “extension” means a variation which is listed in Annex I and fulfils the conditions laid down therein;…’

European Commission and Others v Pharmaceutical Works Polpharma S.A (C-438/21 P)

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