Case C‑452/14

Agenzia Italiana del Farmaco (AIFA)

and

Ministero della Salute

v

Doc Generici Srl

(Request for a preliminary ruling from the Consiglio di Stato)

‛Reference for a preliminary ruling — Article 267 TFEU — Obligation to bring the matter before the Court of Justice — Approximation of laws — Proprietary medicinal products — Medicinal products for human use — Marketing authorisation — Variation — Fees — Regulation (EC) No 297/95 — Regulation (EC) No 1234/2008 — Scope’

Summary — Judgment of the Court (Third Chamber) 1 October 2015

1. Questions referred for a preliminary ruling — Reference to the Court — Questions of interpretation — Obligation to request a preliminary ruling — Scope

   (Art. 267, third para., TFEU)

2. Approximation of laws — Medicinal products for human use — Marketing authorisation — Variation of the authorisation — Change of address of the marketing authorisation holder — Competent national authority demanding payment of as many fees as there are authorisations requiring variation — Lawfulness

   (Council Regulation No 297/95, as amended by Regulation No 273/2012; Commission Regulation No 1234/2008, as amended by Regulation No 712/2012)

3. Questions referred for a preliminary ruling — Jurisdiction of the Court — Identification of the relevant elements of EU law — Reformulation of the questions

   (Art. 267 TFEU)

1.  In accordance with the third paragraph of Article 267 TFEU, a court or tribunal against whose decisions there is no judicial remedy under national law is required, where a question of EU law is raised before it, to comply with its obligation to bring the matter before the Court of Justice, unless it has established that the question raised is irrelevant or that the provision of EU law in question has already been interpreted by the Court or that the correct application of EU law is so obvious as to leave no scope for any reasonable doubt.

   (see para. 43)

2.  Neither Regulation No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products, as amended by Regulation No 273/2012, nor Regulation No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, as amended by Regulation No 712/2012, requires a competent national authority to demand, in respect of the change of address of a marketing authorisation holder, payment of as many fees as there are marketing authorisations requiring variation, and nor do those regulations prohibit such an authority from demanding such payment.

   Regulation No 297/95 does not impose any obligation on national authorities responsible for issuing marketing authorisations for medicinal products. As regards Regulation No 1234/2008, it does not contain any provision governing the amount of fees that may be charged by competent national authorities for processing groupings of Type IA minor variations, such as variations of purely administrative nature that are related to the identity and contact details of the marketing authorisation holder. The question whether those national authorities may demand payment of as many fees as there are marketing authorisations requiring variation, notwithstanding the fact that the applications for variation are grouped together, falls to be determined, in the absence of any legislative provisions adopted by the European Union, by national law.

   (see paras 32, 37, 40, 41, operative part 1)

3.  See the text of the decision.

   (see paras 33, 34)