# C_2015381EN.01001101.xml

| 16.11.2015 | EN | Official Journal of the European Union | C 381/11 |
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16.11.2015

EN

Official Journal of the European Union

C 381/11

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Judgment of the Court (Third Chamber) of 1 October 2015 (request for a preliminary ruling from the Consiglio di Stato — Italy) — Agenzia Italiana del Farmaco (AIFA), Ministero della Salute v Doc Generici Srl

(Case C-452/14) (1)

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((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))

(2015/C 381/12)

Language of the case: Italian

Referring court

Referring court

Consiglio di Stato

Parties to the main proceedings

Parties to the main proceedings

Applicants: Agenzia Italiana del Farmaco (AIFA), Ministero della Salute

Applicants:

Defendant: Doc Generici Srl

Defendant:

Operative part of the judgment

Operative part of the judgment

| 1) | Neither Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products, as amended by Commission Regulation (EU) No 273/2012 of 27 March 2012, nor 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, as amended by Commission Regulation (EU) No 712/2012 of 3 August 2012, requires a competent national authority to demand, in respect of the change of address of a marketing authorisation holder, payment of as many charges as there are marketing authorisations requiring variation, and nor do those regulations prohibit such an authority from demanding such payment. |
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1)

Neither Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products, as amended by Commission Regulation (EU) No 273/2012 of 27 March 2012, nor 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, as amended by Commission Regulation (EU) No 712/2012 of 3 August 2012, requires a competent national authority to demand, in respect of the change of address of a marketing authorisation holder, payment of as many charges as there are marketing authorisations requiring variation, and nor do those regulations prohibit such an authority from demanding such payment.

| 2) | Article 267 TFEU must be interpreted as meaning that a court or tribunal against whose decisions there is no judicial remedy under national law is required, in circumstances such as those in the main proceedings, to comply with its obligation to bring the matter before the Court of Justice. |
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2)

Article 267 TFEU must be interpreted as meaning that a court or tribunal against whose decisions there is no judicial remedy under national law is required, in circumstances such as those in the main proceedings, to comply with its obligation to bring the matter before the Court of Justice.

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(1)  OJ C 448, 15.12.2014.

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