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In the EU, pharmaceuticals are subject to a marketing authorisation requirement that, depending on the type of product concerned, can be obtained either centrally through a Commission decision with EU-wide effects or in the Member States, potentially subject to mutual recognition in composite authorisation procedures. These composite decision-makin...
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Context 1
... Decentralised Procedure facilitates the parallel application in several Member States, in cases where no marketing authorisation has been granted in any Member State (see Figure 2). The application will be submitted to all Member States for which the applicant desires authorisation, but the assessment is carried out by one reference Member State chosen by the applicant. ...
Context 2
... Decentralised Procedure facilitates the parallel application in several Member States, in cases where no marketing authorisation has been granted in any Member State (see Figure 2). The application will be submitted to all Member States for which the applicant desires authorisation, but the assessment is carried out by one reference Member State chosen by the applicant. ...
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... Uznanie rozhodnutia o vyhostení vydaného príslušným orgánom v členskom štáte (vydávajúci členský štát) proti štátnemu príslušníkovi tretej krajiny, ktorý sa nachádza na území iného členského štátu (vykonávajúci členský štát), je predmetom úpravy smernice o vzájomnom uznávaní rozhodnutí o vyhostení štátnych príslušníkov tretích krajín. 91 Rozhodnutie o vyhostení podľa tejto smernice je vydávané správnym orgánom členského štátu Únie (vydávajúci členský štát) podľa jeho vnútroštátnych noriem a jeho cieľom je zabezpečiť vyhostenie štátneho príslušníka tretej krajiny z územia Európskej únie v spolupráci s orgánmi členského štátu Únie, na území ktorého sa zdržiava (vykonávajúci členský štát). Rozhodnutie o vyhostení má cezhraničné účinky, ktorých právny základ vyplýva z práva Európskej únie. ...
One of the instruments through which the free movement of goods, services, capital and persons takes place within the European Union is the exploitation of the cross-border effects of decisions issued by the Member States. The individual Member States shall, on the basis of mutual loyalty and trust, respect on their territory the effects of decisions taken by other Member States. This undoubtedly also applies to administrative decisions or administrative acts. Unlike judicial decisions, whether in private or criminal matters, administrative acts do not have a uniform (or at least similar) regime for recognising the cross-border effects of such decisions. Therefore, within the framework of this monograph, the authors deal with legal regulation within the framework of European Union law, as well as national legal regulation that regulates the legal basis for the application of cross-border effects of home state administrative acts in host states within the European administrative area. On the basis of the identification of such administrative acts, they are subsequently categorised into certain consistent groups within which the same or similar recognition and enforcement rules apply. The establishment of such a categorisation of administrative acts with cross-border effects is a prerequisite for examining the prerequisites and limits for the establishment of a single standardised regime for the recognition and enforcement of administrative acts within the European Union. In addition, the authors deal with possible changes in legislation reflecting their findings in the conducted research, both within the framework of European Union law and within the framework of Slovak national law. To this end, they assess the possibilities of transferring decision-making powers to the bodies of the European Union, define generally acceptable principles for the recognition and enforcement of foreign administrative acts within the European administrative area. In addition, they critically evaluate the existing procedure within the Slovak Administrative Judiciary on the enforceability of decisions of foreign public administration bodies, as well as propose a new procedure for rejecting the effects of decisions of foreign public administrations.
... Further on this see Eliantonio and Roettger-Wirtz[19]; Lanceiro and Eliantonio[27].Content courtesy of Springer Nature, terms of use apply. Rights reserved. ...
Following the outbreak of the Great Financial Crisis, numerous reforms were conducted in all areas of the European Union (EU)’s Economic and Monetary Union. These reforms aimed at strengthening the resilience of Member States’ economies after they had been put under severe strain by the crisis. They included, among others, the reinforcement of the efforts toward economic coordination in the framework of the European Semester for economic policy coordination, or the creation of the European Banking Union after which competences in the areas of banking supervision and bank resolution have been transferred to the European level. More than a decade after the Great Financial Crisis however, several of these reforms are still underway. This article is an introduction to this Special Issue whose contributions examine the reforms performed to date, as well as those that are currently under discussion, from the perspectives of multilevel (administrative) cooperation and the resort to soft law instruments. Indeed, the procedures newly devised rely heavily on the effective cooperation between national and European institutions as well as on a variety of soft law instruments.
Born as a post-modern construction, the European Union does not find its identity defined by positive law nor unilaterally affirmed by means of interpretation of the CJEU. Instead, the notion of identity of the European Union finds a definition and consolidates itself in the institutional capacity of national and supranational courts to engage in a fruitful dialogic relationship. So far, the preliminary reference mechanism has represented the only way for national courts to cooperate with the supranational judiciary in defining a shared understanding of the core values on which the European identity is based. More recently, however, several national courts and scholars have found this bottom-up mechanism insufficient, and are now advocating for the establishment of new institutional tools to enter into a peer-to-peer judicial dialogue. Through a comparative law perspective, this chapter contributes to the discussion about the possible institutional instruments to enhance the judicial dialogue among courts. We conclude that the US practice of federal courts asking for a “certification” of questions of State law to States’ supreme courts could represent a source of inspiration for the CJEU to involve national courts in its decision-making processes with a view to establish a more cooperative judicial federalism in Europe. In particular, we point out that EU law already offers valid tools for such a “reverse preliminary reference” procedure to be implemented in the form of non-binding requests for information or clarification on the interpretation of national law.KeywordsCertificationCertified questions of state lawConstitutional interdependenceCooperative judicial federalismReverse preliminary referenceEU constitutional identityJudicial dialogueNational identity
Masks, gloves, exports licences and composite procedures: Implementing Regulation 2020/402 and the limelight of accountability - Luis Arroyo Jiménez, Mariolina Eliantonio
