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Commission Implementing Regulation (EU) 2018/545Show full title
Commission Implementing Regulation (EU) 2018/545 of 4 April 2018 establishing practical arrangements for the railway vehicle authorisation and railway vehicle type authorisation process pursuant to Directive (EU) 2016/797 of the European Parliament and of the Council (Text with EEA relevance)
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Article 37Coordination between the authorising entity and the concerned NSAs for the area of use for the assessment of the application
1.For the purpose of the assessment of the application, the concerned NSAs for the area of use shall plan, organise and agree on the necessary arrangements in order to take into account the classification of national rules and cross-acceptance referred to in Article 14(10) of Directive (EU) 2016/797. The agreed arrangements for the assessment of the application shall be communicated to the authorising entity and the applicant.
2.The authorising entity and the concerned NSAs for the area of use shall coordinate with each other in order to address any issues including any instances that may require an amendment of the application and/or request for supplementary information, where providing supplementary information has an impact on the time frame of the assessment or has the potential to have an impact on their work, and agree on the way forward.
3.When concluding the coordination activities referred to in paragraph 2, the authorising entity and the concerned NSAs for the area of use shall take each for their own part the decision to inform the applicant through the OSS of any instances that may require an amendment of the application and/or request for supplementary information.
4.Before the authorising entity takes its final decision and before the concerned NSAs for the area of use submit their assessment files, the authorising entity and relevant NSAs for the area of use shall:
(a)discuss the outcome of their respective assessment; and
(b)agree on conditions for use and other restrictions and/or exclusions of area of use to be included in the vehicle type authorisation and/or in the vehicle authorisation for placing on the market.
5.On the basis of outcome of the coordination activities referred to in paragraph 4 of this Article, the authorising entity shall provide to the applicant its documented reasons for the decision. In so doing it shall take into account the assessment files of the concerned NSAs for the area of use, referred to in Article 40(6), regarding the issuing or refusal of the vehicle type authorisation and/or vehicle authorisation for placing on the market, including any conditions for use of the vehicle and other restrictions and/or exclusions of area of use to be included in the vehicle type authorisation and/or vehicle authorisation for placing on the market.
6.Records of the coordination activities shall be taken by the authorising entity and maintained in the one-stop shop in accordance with Article 36.
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