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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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- Revised 16/06/20200.51 MB
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Changes over time for: Article 41
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Article 41U.K.Categorisation of issues
1.The authorising entity and, when applicable the concerned NSAs for the area of use, shall record issues identified during the course of their assessment of the application file in an issues log and categorise them as follows:
(a) ‘type 1’
:
issue that requires a response from the applicant for the understanding of the application file;
(b) ‘type 2’
:
issue that may lead to an amendment of the application file or minor action from the applicant; the action to be taken shall be left to the judgement of the applicant and shall not prevent the issuing of the vehicle type authorisation and/or the vehicle authorisation for placing on the market;
(c) ‘type 3’
:
issue that requires an amendment to the application file by the applicant but does not prevent the issuing of the vehicle type authorisation and/or vehicle authorisation for placing on the market with additional and/or more restrictive conditions for use of the vehicle and other restrictions as compared to those specified by the applicant in its application, but the issue must be addressed in order to issue the vehicle type authorisation and/or vehicle authorisation for placing on the market; any action to be performed by the applicant to resolve the issue shall be proposed by the applicant and shall be agreed with the party that identified the issue;
(d) ‘type 4’
:
issue that requires an amendment of the application file by the applicant; the vehicle type authorisation and/or vehicle authorisation for placing on the market shall not be delivered unless the issue is resolved; any action to be performed by the applicant to resolve the issue shall be proposed by the applicant and shall be agreed with the party that identified the issue. Type 4 issue shall include in particular non-compliance pursuant to Article 26(2) of Directive (EU) 2016/797.
2.Following the response or the action taken by applicant according to the issue, the authorising entity or the concerned NSAs for the area of use shall re-evaluate the issues it identified, re-classify where relevant and assign one of the following status for each of the issues identified:
(a)‘issue pending’ when the evidence provided by the applicant is not satisfactory and additional information is still required;
(b)‘issue closed out’ when a suitable response has been provided by the applicant and no residual matter of concern remains.
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