Примери за използване на Coordinating member state на Английски и техните преводи на Български
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The Council is responsible for coordinating member states' policies in specific fields, such as.
With regard to documentation other than that referred to in the second subparagraph of paragraph 3, the coordinating Member State shall.
If they do not agree on a coordinating Member State, the coordinating Member State proposed by the sponsor shall assume that role.
Within six daysof receipt of the single application, notify the sponsor that it is the coordinating Member State(‘notification date');
The coordinating Member State and the Commission shall be kept informed of the outcome of any such evaluation and the adoption of any such measures.
The Commission shall provide secretarial support to the coordinating Member State in the accomplishment of its tasks provided for in this Chapter.
In the single application,the sponsor shall propose one of The Member States concerned as coordinating Member State.
The European Union encourages lifelong learning by coordinating Member State cooperation on training and formal, non-formal, and informal education.
The sponsor shall propose in the single application referred to in paragraph 1 that one of the Member States in which the clinical investigation is to be conducted acts as coordinating Member State.
For class IIb andclass III devices, the coordinating Member State may also extend the periods referred to in paragraph 4 by a further 50 days, for the purpose of consulting with experts.
(30) In order to enhance the efficiency of market surveillance,the Agency should be responsible for coordinating Member States' pharmacovigilance activities.
Under the direction of the coordinating Member State referred to in paragraph 2, the Member States concerned shallcoordinate their assessment of the application, in particular of the documentation referred to in Chapter II of Annex XV.
The Member States in which the clinical investigation is to be conducted shall, within six days of submission of the application,agree on one of them taking the role of the coordinating Member State.
Notwithstanding the first subparagraph, a Member State concerned may only disagree with the conclusion of the coordinating Member State concerning the area of coordinated assessment on the following grounds.
As a consequence, the health andsafety aspects regarding the device intended for clinical investigation will be assessed by the Member States concerned under the direction of a coordinating Member State.
Notwithstanding the first subparagraph,a Member State concerned may only disagree with the conclusion of the coordinating Member State concerning the area of coordinated assessment on the following grounds.
Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the performance study is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned.
Commission staff to provide scientific, technical and logistic support to the MDCG,to its sub-groups and to the coordinating Member States in the fields of clinical investigations and vigilance;
Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the conduct of the performance study is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of all Member State(s) concerned.
Given the complex and heterogeneous situation concerning animal diseases in the EU,it is important that the Commission applies a sound framework for prioritising its funding efforts, coordinating Member State efforts, providing guidance and facilitating best practices.
This is mentioned, among other things,in the Commission communication on coordinating Member States' direct tax systems in the internal market, especially in the final version of document COM 2006/823.
In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety-related aspects of the device for performance study and of the scientific design of that performance study,the procedure for the assessment of such single application should be coordinated between the Member States under the direction of a coordinating Member State.
In connection with the two communications from the Commission on coordinating Member State systems of direct taxation on the internal market and retirement tax, ECOFIN adopted the December 2008 Council resolution on retirement tax.
In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety-related aspects of the device for performance study and of the scientific design of that performance study,the procedure for the assessment of such single application should be coordinated between the Member States under the direction of a coordinating Member State.
Under the direction of the coordinating Member State referred to in Article 56(2), the Member States shall coordinate their assessment of serious adverse events and device deficiencies to determine whether a clinical performance study needs to be terminated, suspended, temporarily halted or modified.
Any assessment as to whether there are grounds for disagreement as referred to in the second subparagraph of paragraph 8 of this Article shall be carried out under the direction of the coordinating Member State, except for substantial modifications concerning Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV, which shall be assessed separately by each Member State concerned.
Under the direction of the coordinating Member State referred to in Article 78(2), the Member States shall coordinate their assessment of serious adverse events and device deficiencies to determine whether to modify, suspend or terminate the clinical investigation or whether to revoke the authorisation for that clinical investigation.
Any assessment as to whether there are grounds for disagreement as referred to in the second subparagraph of paragraph 8 of this Article shall be carried out under the direction of the coordinating Member State, except for substantial modifications concerning sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV and point(c) of Section 2.3.2 of Part A of Annex XIII, which shall be assessed separately by each Member State concerned.
In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety related aspects of the device for performance evaluation and of the scientific design of the clinical performance study to be conducted in several Member Stats,such single application should facilitate the coordination between the Member States under the direction of a coordinating Member State.
By day 38 after the validation date, the other Member States concerned shall transmit their comments and proposals on the draft assessment report andthe underlying application to the coordinating Member State which shall take due account of those comments and proposals in its finalisation of the final assessment report, to be transmitted within 45 days of the validation date to the sponsor and the other Member States concerned.