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Document 62014CN0452

    Case C-452/14: Request for a preliminary ruling from the Consiglio di Stato (Italy) lodged on 29 September 2014  — Agenzia Italiana del Farmaco (AIFA), Ministry for Health v Doc Generici srl

    OJ C 448, 15.12.2014, p. 8–9 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    15.12.2014   

    EN

    Official Journal of the European Union

    C 448/8

    Request for a preliminary ruling from the Consiglio di Stato (Italy) lodged on 29 September 2014 — Agenzia Italiana del Farmaco (AIFA), Ministry for Health v Doc Generici srl

    (Case C-452/14)

    (2014/C 448/11)

    Language of the case: Italian

    Referring court

    Consiglio di Stato

    Parties to the main proceedings

    Applicants: Agenzia Italiana del Farmaco (AIFA), Ministry for Health

    Defendant: Doc Generici srl

    Questions referred

    1.

    Must Article 3(2)(a) of Council Regulation (EC) No 297/95 of 10 February 1995 (1), in the version currently in force, be interpreted as meaning that Type I marketing authorisation variations — and, in particular, in respect of the case in the main proceedings, Type IA variations — where an identical variation affecting several authorisations belonging to the same holder are concerned, are subject to a single fee, to the extent specified therein, or to as many fees as there are authorisations affected by the variation?

    2.

    In the circumstances in the present proceedings, may or must, as held by this Chamber, the question be referred to the Court of Justice?

    (1)  Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ 1995 L 35, 15.2.1995, p. 1).

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