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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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CHAPTER 3U.K. PRE-ENGAGEMENT

Article 22U.K.Pre-engagement

1.Upon the applicant's request, the authorising entity and the concerned NSAs for the area of use shall handle pre-engagement applications to set the pre-engagement baseline before an application for a vehicle type authorisation and/or vehicle authorisation for placing on the market is submitted. The pre-engagement application shall be formally submitted by the applicant through the one-stop shop and be accompanied by a file containing at least the required information specified in Article 23.

2.The time frame from the issuing of the opinion referred to in Article 24(2) to the applicant's submission of the application for vehicle type authorisation and/or vehicle authorisation for placing on the market shall not exceed 84 months.

3.The selection of authorising entity made by the applicant for the pre-engagement shall be binding until, either:

(a)the concerned application for vehicle type authorisation and/or vehicle authorisation for placing in the market has been submitted by the applicant;

(b)the time frame from the issuing of the opinion referred to in Article 24(2) to the applicant's submission of the application for vehicle type authorisation and/or vehicle authorisation for placing on the market as specified in paragraph 2 has expired; or

(c)the applicant has requested to end the pre-engagement.

4.When during the pre-engagement, the applicant wishes to change the authorising entity it shall request the termination of the existing pre-engagement. The applicant may then send a new pre-engagement application to a new authorising entity.

5.The applicant may introduce an application for authorisation through the one-stop shop at any time during the pre-engagement process. In this case, the pre-engagement phase is terminated.

6.In case of pre-engagement, the points set out in Article 41 related to the identification and the categorisation of issues shall be used, in view of tracking issues raised with the applicant by the authorising entity and, when applicable, the concerned NSAs for the area of use.

Article 23U.K.Pre-engagement file

The pre-engagement file accompanying the pre-engagement application shall contain the following:

(a)

a description of the vehicle type and/or vehicle to be authorised, including where applicable the intended variants and/or versions, and a description of the tasks and activities to develop it;

(b)

the applicant's choice of the authorising entity and of the authorisation case or cases pursuant to Article 14;

(c)

a specification of the intended area of use;

(d)

a specification of the anticipated conditions for use of the vehicle and other restrictions identified pursuant to Article 20;

(e)

the applicant's planning for its part of the vehicle authorisation process, including the planning that covers tests on the network, when applicable;

(f)

an identification of the methodology for the process for the requirements capture in accordance with Article 13;

(g)

the list of the rules and requirements identified by the applicant as those that are to be applied in accordance with Article 17 to Article 18;

(h)

a list of the identified conformity assessments pursuant to Article 21, including the modules to be applied and the use of Intermediate Statements of Verification (‘ISV’), where applicable;

(i)

a description of the practical arrangements to use the vehicle for tests on the network, where applicable;

(j)

a list of the content of the documentation that the applicant anticipates to submit to the authorising entity and the concerned NSAs for the area of use for the vehicle type authorisation and/or vehicle authorisation for placing on the market;

(k)

a proposal concerning the language to be used for the vehicle authorisation process pursuant to Article 10;

(l)

a description of the applicant's organisation for its part of the vehicle authorisation process including but not limited to the applicant's contact information, contact persons information, requests for setting up coordination and meetings with the authorising entity and the concerned NSAs for the area of use.

Article 24U.K.Pre-engagement baseline

1.Within one month from the date of receipt of the pre-engagement application the authorising entity and the concerned NSAs for the area of use shall inform the applicant that the pre-engagement file is complete or ask for the relevant supplementary information, setting a reasonable deadline for the provision thereof.

2.Where the applicant is informed that their file is complete, the authorising entity and the concerned NSAs for the area of use shall issue through the one-stop shop an opinion on the approach proposed by the applicant in the pre-engagement application no later than two months after the acknowledgement that the file is complete. That issued opinion establishes the pre-engagement baseline, including a determination of the version of the TSIs and national rules that are to be applied for the subsequent application for authorisation without prejudice to paragraph 4.

3.The pre-engagement baseline shall specify which language shall be used pursuant to Article 10.

4.In case of changes affecting the pre-engagement file which are relevant for the pre-engagement baseline, the applicant shall send an amended and updated pre-engagement application only considering the changes and the interfaces with the unchanged parts. This may occur in the following situations:

(a)changes to the design or to the assessment methodology resulting from major safety issues;

(b)changes in legal requirements invalidating the pre-engagement baseline; or

(c)any changes voluntarily introduced by the applicant.

5.The authorising entity and where applicable the concerned NSAs for the area of use shall within 1 month review and issue an opinion on the amended and updated pre-engagement application and record that opinion in an amended and updated pre-engagement baseline.

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