CELEX: 62011CJ0145
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

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.