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Valentina R., lawyer
Failure of a Member State to fulfil obligations – Directive 2004/24/EC – Pharmaceutical specialities – Traditional herbal medicinal products – Community code – Medicinal products for human use – Failure to transpose within the period prescribed
Actions for failure to fulfil obligations – Examination of merits by the Court – Situation to be taken into consideration – Situation on expiry of the period laid down in the reasoned opinion (Art. 226 EC) (see para. 9)
Failure of a Member State to fulfil its obligations – Failure to adopt within the period prescribed the provisions necessary to comply with Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ 2004 L 136, p. 85).
Declares that, by failing to adopt, within the period prescribed, the laws, regulations and administrative provisions necessary to comply with Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, the Kingdom of Spain has failed to fulfil its obligations under that directive.
Orders the Kingdom of Spain to pay the costs.