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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
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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? |
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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).