ECLI:EU:C:2012:490•Judgment of the Court (Third Chamber) of 19 July 2012.#European Commission v French Republic.#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.#Case C‑145/11.
Judgment of the Court (Third Chamber) of 19 July 2012.#European Commission v French Republic.#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.#Case C‑145/11.
ECLI:EU:C:2012:490Eu Chamb 03 CJul 19, 2012
Full text
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. |
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