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European Court of Justice

机译:欧洲法院

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摘要

In this reference for a preliminary ruling, the High Court of Justice of England and Wales, Queen's Bench Division (Administrative Court) (United Kingdom), requests the Court to interpret Article 28 of Directive 2001/83 which establishes a procedure for the mutual recognition of marketing authorisations for medicinal products.The Court is asked, essentially, to rule on the scope of the discretion enjoyed by a Member State when it receives an application for mutual recognition of a marketing authorisation ('the Member State concerned,) issued by another Member State ('the reference Member State') under the abridged procedure provided for in Article 10(l)(a)(iii) of Directive 2001/83.
机译:在此参考中,作为一项初步裁决,英格兰和威尔士高等法院,女王基准法院分庭(行政法院)(联合王国),要求法院解释第2001/83号指令第28条,该条确立了相互承认的程序本质上,要求法院裁定成员国在收到另一方签发的相互认可的市场营销许可申请(“有关成员国”)时享有的酌处权范围。根据第2001/83号指令第10(l)(a)(iii)条规定的简化程序的成员国(“参考成员国”)。

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