Judgment of the Court (Third Chamber) of 19 July 2012 — Commission v France

(Case C-145/11)

‛Failure of a Member State to fulfil obligations — Directive 2001/82/EC — Veterinary medicinal products — Decentralised procedure for the grant of marketing authorisation for a veterinary medicinal product in a number of Member States — Generic medicinal products similar to the reference medicinal products already authorised — Refusal to approve request by a Member State — Composition and form of the medicinal product’

Approximation of laws — Veterinary medicinal products — Directive 2001/82 — Marketing authorisation — Decentralised procedure — Application in conformity with the formal requirements for applications for authorisation — Refusal to approve by a Member State on substantive grounds — Failure to fulfil obligations (Art. 258 TFEU; European Parliament and Council Directive 2001/82, Arts 32 and 33) (see paras 32-39, 43, 45, 46, 48, operative part)

Re:

Failure of a Member State to fulfil obligations — Infringement of Articles 32 and 33 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p. 1) — Decentralised procedure for the grant of marketing authorisation in more than one Member State — Generic medicinal products similar to the reference medicinal products already authorised — Member State’s refusal to approve based on scientific grounds related to the composition of the medicinal product and the choice of pharmaceutical form — Principle of mutual recognition.

Operative part

The Court:

1. Declares that, by refusing to approve two requests for marketing authorisation of the medicinal veterinary products CT-Line 15% Premix and CT-Line 15% Oral Powder in the context of the decentralised procedure provided for by Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amended by Directive 2004/28/EC of the European Parliament of the Council of 31 March 2004, the French Republic has failed to fulfil its obligations under Articles 32 and 33 of that directive;

2. Orders the French Republic to pay the costs.

Judgment of the Court (Third Chamber) of 19 July 2012 — Commission v France

(Case C-145/11)

‛Failure of a Member State to fulfil obligations — Directive 2001/82/EC — Veterinary medicinal products — Decentralised procedure for the grant of marketing authorisation for a veterinary medicinal product in a number of Member States — Generic medicinal products similar to the reference medicinal products already authorised — Refusal to approve request by a Member State — Composition and form of the medicinal product’

Approximation of laws — Veterinary medicinal products — Directive 2001/82 — Marketing authorisation — Decentralised procedure — Application in conformity with the formal requirements for applications for authorisation — Refusal to approve by a Member State on substantive grounds — Failure to fulfil obligations (Art. 258 TFEU; European Parliament and Council Directive 2001/82, Arts 32 and 33) (see paras 32-39, 43, 45, 46, 48, operative part)

Re:

Failure of a Member State to fulfil obligations — Infringement of Articles 32 and 33 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p. 1) — Decentralised procedure for the grant of marketing authorisation in more than one Member State — Generic medicinal products similar to the reference medicinal products already authorised — Member State’s refusal to approve based on scientific grounds related to the composition of the medicinal product and the choice of pharmaceutical form — Principle of mutual recognition.

Operative part

The Court:

1. Declares that, by refusing to approve two requests for marketing authorisation of the medicinal veterinary products CT-Line 15% Premix and CT-Line 15% Oral Powder in the context of the decentralised procedure provided for by Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amended by Directive 2004/28/EC of the European Parliament of the Council of 31 March 2004, the French Republic has failed to fulfil its obligations under Articles 32 and 33 of that directive;