Decentralised procedures for the authorisation of medicines in the EU Law: some problems of effective judicial protection
DOI:
https://doi.org/10.18042/cepc/rdce.67.05Abstract
The European regulation on procedures for the authorisation of medicinal products, together with a model of direct enforcement, designs several types of enforcement by Member States, with varying degrees of collaboration between them. The so-called “decentralised procedure” is configured as a horizontal (compound) network procedure, where the Member States participate on an equal footing in the assessment of scientific risk, each of them granting the corresponding marketing authorisation. This configuration raises problems of judicial protection of third party competitors as a result of the principle of double exclusivity of the competence of the Court of Justice of the European Union and the national courts. Any shortcomings in judicial control must be resolved in the light of the principle of loyal cooperation, to give rise to a system of decentralised control based on dialogue between the national courts.
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