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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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The applicant for a vehicle type authorisation and/or a vehicle authorisation for placing on the market shall establish the evidence for the application by:
putting together the EC declarations of verification for the subsystems composing the vehicle and providing the evidence, in the technical file accompanying the EC declarations, of the conclusions of the conformity assessments done following the identification carried out pursuant to Article 21;
ensuring that interfaces between subsystems that are not defined in TSIs and/or national rules, are covered by the requirements capture referred to in Article 13 and meet the essential requirements set out in Article 3(1) of Directive (EU) 2016/797.
1.The applicant shall prepare and compile in a structured way the content that is required for the file accompanying the application in accordance with Annex I.
2.For the authorisation referred to in Article 14(1)(b), (c), (d), and (e), the applicant shall check the validity of the existing vehicle type authorisation.
3.The applicant shall, for the authorisation referred to in Article 14(1)(c) and (d), submit the documentation necessary for the authorising entity to issue its decision, including where available any documentation accompanying the file for the previous authorisation.
1.For the application to be considered complete by the authorising entity and when relevant by the concerned NSAs for the area of use it shall contain the information set out in Annex I.
2.For the authorisation extended area of use referred to in Article 14(1)(c), the following points shall apply:
(a)the documentation to be added to the original full accompanying file for the decision issued in accordance with Article 46 by the applicant shall be limited to aspects concerning the relevant national rules and the technical compatibility between the vehicle and the network for the extended area of use;
(b)when the original vehicle type authorisation included non-applications of TSIs, the applicant shall add the relevant decisions for non-application of TSIs in accordance with Article 7 of Directive (EU) 2016/797 covering the extended area of use to the original full accompanying file for the decision issued in accordance with Article 46;
(c)in case of vehicles and/or vehicle types authorised under Directive 2008/57/EC or before, the information to be added by the applicant to the original file for the aspects covered by point (a) shall also include the applicable national rules.
1.The application for a vehicle type authorisation and/or a vehicle authorisation for placing on the market shall be formally submitted by the applicant through the single entry point of the one-stop shop referred to in Article 12 of Regulation (EU) 2016/796 and shall contain the information set out in Annex I.
2.When submitting its application for a vehicle type authorisation and/or a vehicle authorisation for placing on the market the applicant shall select the authorising entity in accordance with Article 21(5) and 21(8) of Directive (EU) 2016/797.
3.The selection of authorising entity made by the applicant shall be binding until the decision on the issuing of the vehicle type authorisation and/or the vehicle authorisation for placing on the market or the refusal of the application has been taken by the authorising entity or the application has been terminated by the applicant.
4.The applicant's file shall be referred through the one-stop shop to the concerned NSAs for the area of use.
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