Brussels, 24 November 2010
Medicinal products for animals: Commission refers France to the Court of Justice for disregarding rules on the authorisation of two veterinary medicinal products.
The European Commission has today referred France to the European Court of Justice for not complying with EU law on harmonised authorisation procedures for veterinary medicinal products. The breach the Commission asks the Court to investigate, is France's refusal to process applications for marketing authorisation for two veterinary medicinal products.
According to the provisions of Directive 2001/82/EC, medicinal products for veterinary use have to be authorised either at Member State or EU level, before they can be placed on the EU market. This is to ensure the highest possible level of animal health while securing the availability of such products across the EU. The harmonised authorisation procedure laid out in this Directive consists of several stages. The first is an initial validation phase to check the admissibility of the application. This is followed by the main phase which is a detailed evaluation process to assess the quality, safety and efficacy of the product.
In the present case, which concerns two applications of veterinary medicinal products submitted via the decentralised procedure to several Member States, France was the only Member State to refuse initial validation. In the Commission’s view, the reasons for this refusal do not relate to admissibility of the application, but to the scientific assessment of the product. According to Directive 2001/82/EC a Member State cannot prevent the scientific evaluation of a medicinal product by unilaterally refusing to validate the admissibility of its application. Such unilateral action undermines the harmonised authorisation procedure.
Therefore, the Commission has today referred France to the European Court of Justice for not complying with EU law on the above mentioned harmonised authorisation procedures for veterinary medicinal products. The Court is asked to investigate France's refusal to process applications for marketing authorisation for two veterinary medicinal products.
For more details on infringement procedures, see MEMO/10/605
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