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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 46Decision for the authorisation or the refusal of the application

1.The authorising entity shall take a decision to issue the vehicle type authorisation and/or vehicle authorisation for placing on the market or to refuse the application within one week following the completion of the assessment without prejudice to the provisions of Article 34. That decision shall be taken on the grounds of the documented reasons referred to in Article 45(5).

2.The vehicle type authorisation and/or vehicle authorisation for placing on the market shall be issued by the authorising entity where the assessment of the aspects listed in Annex II and where applicable Annex III support a reasonable assurance that the applicant and the actors supporting the applicant have fulfilled their responsibilities to the extent required, in accordance with Article 38.

3.Where, following the assessment of the aspects listed in Annex II and where applicable Annex III do not support a reasonable assurance that the applicant and the actors supporting the applicant have fulfilled their obligations and responsibilities to the extent required, in accordance with Article 38, the authorising entity shall refuse the application.

4.The authorising entity shall state the following in its decision:

(a)any conditions for use of the vehicle and other restrictions;

(b)the reasons for the decision;

(c)the possibility and means of appealing the decision and the relevant time limits.

5.The conditions for use of the vehicle and other restrictions shall be defined according to the basic design characteristics of the vehicle type.

6.The authorisation decision shall not contain any time limited conditions for use of the vehicle and other restrictions, unless the following conditions are fulfilled:

(a)it is required because the conformity to the TSIs and/or national rules cannot be completely proven before the issuing of the authorisation; and/or

(b)the TSIs and/or national rules require that the applicant produces a plausible estimate of compliance.

The authorisation may then include a condition that real use demonstrates performance in line with the estimate within a specified period of time.

7.The final decision to issue the vehicle type authorisation and/or vehicle authorisation for placing on the market or to refuse the application shall be recorded in the one-stop shop and communicated together with the assessment files through the one-stop shop to the applicant and the concerned NSAs for the area of use.

8.Where the decision either refuses the application or issues the vehicle type authorisation and/or vehicle authorisation for placing on the market subject to different conditions for use of the vehicle and other restrictions when compared to those specified by the applicant in its application, the applicant may request that the authorising entity reviews its decision in accordance with Article 51 of this Regulation. Where the applicant is not satisfied with the reply of the authorising entity, it may bring an appeal before the competent authority in accordance with Article 21(11) of Directive (EU) 2016/797.

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