CHAPTER 6

PROCESSING THE APPLICATION

Application completeness check
Article 32
1
The authorising entity shall check the completeness of the information and documentation provided by the applicant in the application in accordance with Article 30.
2
The concerned NSAs for the area of use shall:
a
check that the area of use is correctly specified for its part;
b
raise any issues concerning the completeness of the information and documentation provided for the assessment of the applicable national rules as specified in Annex III.
3
The completeness check referred to in paragraph 1 and 2 shall constitute a verification by the authorising entity, and the concerned NSAs for the area of use that:
a
all the required information and documents referred to in Article 30 have been provided by the applicant in the application for vehicle type authorisation and/or vehicle authorisation for placing on the market;
b
the provided information and documentation provided is considered relevant to allow the authorising entity and the concerned NSAs for the area of use to perform their assessments in accordance with Article 38 to Article 40.

Acknowledgement of application
Article 33
1
The one-stop shop shall generate an automatic acknowledgment of the receipt of the application to the applicant.
2
The assessment of the application shall start on the date of receipt of the application.

Time frame for the assessment of the application
Article 34
1
The authorising entity and the concerned NSAs for the area of use shall evaluate, each for their own part, the completeness of the application as specified in Article 32 within one month following the date of receipt of the application. The authorising entity shall inform the applicant accordingly.
2
Where the applicant is informed that their file is complete, the final decision over the issuing of the vehicle type authorisation and/or vehicle authorisation for placing on the market shall be taken no later than four months after the acknowledgement that the file is complete.
3
The decision of the authorising entity shall be issued within one month following the date of receipt of the application in case of authorisation in conformity to type in accordance with Article 14(1)(e).
4
If the applicant is informed that its file is not complete, the final decision over the issuing of the vehicle type authorisation and/or vehicle authorisation for placing on the market shall be taken no later than four months following the submission of the missing information by the applicant, unless the application is fundamentally deficient, in which case it shall be rejected.
5
In the course of the assessment, even if the application is complete as referred to in paragraph 2, the authorising entity or the concerned NSAs for the area of use may, at any time, request supplementary information, setting a reasonable deadline for the provision thereof, without suspending the assessment unless the provisions of paragraph 6 apply.
6
When a justified doubt has been raised by the authorising entity or the concerned NSAs for the area of use and the applicant is required to provide supplementary information, the authorising entity may suspend the assessment and in duly recorded agreement with the applicant extend the time frame beyond what is set out in Article 21(4) of Directive (EU) 2016/797. The time frame for providing the supplementary information shall be proportionate to the difficulty for the applicant to provide the information requested. The assessment and the time frame shall resume after the applicant provides the requested information. In the absence of agreement with the applicant, the authorising entity or the concerned NSAs for the area of use shall take its decision based on the available information.

Communication during the assessment of the application
Article 35
1
The authorising entity, the concerned NSAs for the area of use and the applicant shall communicate through the one-stop shop as regards any issue referred to in Article 41.
2
The status of all stages of the vehicle authorisation process, the decision on the application and the documented reasons for that decision shall be communicated to the applicant through the one-stop shop.
3
The guidelines of the Agency and of the NSAs shall indicate arrangements for communicating between themselves and with the applicant.

Information management concerning the assessment of the application
Article 36
1
The authorising entity and the concerned NSAs for the area of use shall register in the one-stop shop the outcomes of the stages of the vehicle authorisation process in which they are involved, each for their respective part of the assessment as applicable, including all the documents relating to the application concerning the following:
a
receipt;
b
handling;
c
assessment;
d
conclusions of the assessment of the application as specified in Article 45;
e
final decision to issue or not the vehicle type authorisation or the vehicle authorisation for placing on the market;
f
final documentation for the vehicle type authorisation and/or the vehicle authorisation for placing on the market in accordance to Article 47.
2
The final decision to issue or not the vehicle type authorisation and/or vehicle authorisation for placing on the market shall be communicated to the applicant through the one-stop shop.
3
For the documents listed in paragraph 1, the authorising entity and the concerned NSAs for area of use shall use the document control process provided by the one-stop shop.
4
Where the NSAs use an information management system for processing the applications addressed to them, they shall transfer all relevant information to the one-stop shop.

Coordination between the authorising entity and the concerned NSAs for the area of use for the assessment of the application
Article 37
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.

Assessment of the application
Article 38
The assessment of the application shall be carried out by the authorising entity and the concerned NSAs for the area of use to establish a reasonable assurance that the applicant and the actors supporting the applicant have fulfilled their obligations and responsibilities in the design, manufacture, verification and validation stages of the vehicle and/or vehicle type in order to ensure conformity with the essential requirements of the applicable legislation so that it may be placed on the market and may be used safely in the area of use of the vehicle type according to the conditions of use and other restrictions specified within the application.

The assessment of the application by the authorising entity
Article 39
1
The authorising entity shall assess the aspects specified in Annex II.
2
Where a vehicle type authorisation and/or vehicle authorisation for placing on the market is to be issued for an area of use that is limited to the networks within one Member State and where the applicant has requested for the NSA to be the authorising entity in accordance with Article 21(8) of Directive (EU) 2016/797, the authorising entity shall, in addition to the assessments specified in paragraph 1, assess the aspects referred to in Annex III. In that case the authorising entity shall, in addition to those aspects listed in Annex III, also check whether there is any relevant information recorded pursuant to Article 8(2) and shall take it into account for the assessment of the application. Any issues raised shall be recorded in the issues log as specified in Article 41.
3
When a non-standardised methodology for the requirements capture has been used by the applicant, the authorising entity shall assess the methodology applying the criteria laid down in Annex II.
4
The authorising entity shall check the completeness, relevance and consistency of the evidence from the applied methodology for requirements capture irrespective of the method used. For a new authorisation as specified in Article 14(1)(d) the assessment performed by the authorising entity shall be limited to the parts of the vehicle that are changed and their impacts on the unchanged parts of the vehicle. The checks to be performed by the authorising entity for an ‘extended area of use’ authorisation as specified in Article 14(1)(c) shall be limited to the applicable national rules and to the technical compatibility between the vehicle and the network for the extended area of use. Checks already carried out at the previous authorisation shall not be repeated by the authorising entity.
5
An assessment file shall be issued by the authorising entity and shall contain the following:
a
clear statement on whether the result of the assessment is negative or positive as per the applicant's request for the concerned area of use and, where appropriate, conditions for use or restrictions;
b
summary of the assessments performed;
c
report from the issues log for the concerned area of use;
d
filled-in checklist giving evidence that all aspects specified in Annex II, and when applicable Annex III, have been assessed.

The assessment of the application by the concerned NSAs for the area of use
Article 40
1
The concerned NSAs for the area of use shall assess the aspects listed in Annex III. The assessments to be performed by the NSAs for the area of use shall only concern the relevant national rules for the area of use taking into account the agreed arrangements referred to in Article 37(1).
2
In the assessment of the requirements capture, the NSAs for the area of use shall check the completeness, relevance and consistency of the evidence produced by the applicant from the applied methodology for requirements capture.
3
For a new authorisation referred to in Article 14(1)(d), the assessment performed by the NSAs for the area of use shall be limited to the parts of the vehicle that are changed and their impacts on the unchanged parts of the vehicle.
4
The checks to be performed by the NSAs for the area of use for an extended area of use authorisation referred to in Article 14(1)(c) shall be limited to the applicable national rules and to the technical compatibility between the vehicle and the network for the extended area of use. Checks already carried out during the previous authorisation shall not be repeated by the NSAs for the area of use.
5
In accordance with Articles 6 and 14 of Directive (EU) 2016/797, the NSAs for the area of use shall, in addition to those aspects specified in Annex III, check if there is any relevant information recorded pursuant to Article 8(2) and shall take it into account for the assessment of the application. Any issues raised shall be recorded in the issues log as specified in Article 41.
6
An assessment file shall be issued by the NSAs for the area of use and shall contain the following:
a
a clear statement on whether the result of the assessment is negative or positive as per the applicant's request for the concerned area of use and where appropriate conditions of use and restrictions;
b
a summary of the assessments performed;
c
a report based on the issues log for the concerned area of use;
d
a filled-in checklist giving evidence that all aspects listed in Annex III have been assessed.

Categorisation of issues
Article 41
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.

Justified doubt
Article 42
1
Where there is a justified doubt, the authorising entity and/or the concerned NSAs for the area of use may, alternatively, do one or more of the following:
a
perform a more thorough and detailed check of the information provided in the application;
b
request supplementary information from the applicant;
c
request that the applicant conducts tests on the network.
2
The request from the authorising entity and/or the concerned NSAs for the area of use shall specify the matter that requires action from the applicant but shall not specify the nature or content of the corrective actions to be performed by the applicant. The applicant shall decide on what is the most suitable way for it to answer to the request from the authorising entity and/or the concerned NSAs for the area of use in.
3
The authorising entity shall coordinate with the concerned NSAs for the area of use regarding the actions proposed by the applicant.
4
The authorising entity and the concerned NSAs for the area of use shall, without prejudice to the provisions of Article 35, use the issues log referred to in Article 41 to manage any justified doubts. A justified doubt shall always:
a
be classified as a type 4 issue pursuant to Article 41(1)(d);
b
be accompanied by a justification; and
c
include a clear description of the matter that needs to be answered by the applicant.
5
Where the applicant agrees to provide supplementary information, pursuant to points (b) and (c) of paragraph 1 at the request of the authorising entity and/or the concerned NSAs for the area of use, the time frame to provide that supplementary information shall be established in accordance with Article 34(5) and Article 34(6).
6
Where it is possible to remove a justified doubt by introducing 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 and the applicant so agrees, a vehicle type authorisation and/or vehicle authorisation for placing on the market may be issued under such conditions for use of the vehicle and other restrictions.
7
Where the applicant does not agree to provide further information to remove the justified doubt raised by the authorising entity and/or the concerned NSAs for the area of use, the authorising entity shall take a decision on the basis of the available information.

The checks to be performed by the authorising entity concerning the assessments performed by the concerned NSAs for the area of use
Article 43
1
The authorising entity shall check whether the assessments from the NSAs for the area of use are consistent with each other as regards the results of the assessments referred to in Article 40(6)(a).
2
Where the result from the check referred to in paragraph 1 demonstrates that the assessments of the NSAs for the area of use are consistent, the authorising entity shall verify that:
a
the checklists referred to in Article 40(6)(d) have been filled-in completely;
b
all relevant issues have been closed.
3
Where the result from the check in paragraph 1 demonstrates that the assessments are not consistent, the authorising entity shall request the concerned NSAs for the area of use to further investigate the reasons. As a result of this investigation, alternatively, one or both of the following shall apply:
a
the authorising entity may review its assessment as referred to in Article 39;
b
the concerned NSAs for the area of use may review its assessment.
4
The outcomes of investigations of the NSAs for the area of use referred to in paragraph 3 shall be shared with all the NSAs for the area of use involved in the application for the vehicle type authorisation and/or the vehicle authorisation.
5
Where a checklist referred to in paragraph 2(a) is incomplete or where there are issues that have not been closed pursuant to paragraph 2(b), the authorising entity shall request the concerned NSAs for the area of use to further investigate the reasons.
6
The NSAs for the area of use shall provide replies to requests from the authorising entity with regard to inconsistencies in the assessments referred to in paragraph 3, incompleteness in the checklists referred to in paragraph 2(a) and/or issues that are not closed in accordance with paragraph 2(b). The authorising entity shall take full account of the assessments performed by the NSAs for the area of use concerning the applicable national rules. The extent of checks performed by the authorising entity shall be limited to the consistency of the assessments and the completeness of the assessments referred to in paragraphs 1 and 2.
7
In case of disagreement between the authorising entity and the concerned NSAs for the area of use, the arbitration procedure referred to in Article 21(7) of Directive (EU) 2016/797 shall be applied.

Arbitration under Article 21(7) of Directive (EU) 2016/797 and Article 12(4)(b) of Regulation (EU) 2016/796
Article 44
Where the Agency acts as the authorising entity, it may suspend the authorisation process, in consultation with the concerned NSAs for the area of use, during the cooperation needed to reach a mutually acceptable assessment and where applicable, until the Board of Appeal takes a decision, within the time frames set out in Article 21(7) of Directive (EU) 2016/797. The Agency shall give the applicant reasons for the suspension.

Conclusion of the assessment of the application
Article 45
1
The authorising entity shall ensure that the process for the assessment of the application has been carried out correctly by checking in an independent manner that:
a
the different stages of the process for the assessment of the application have been correctly applied;
b
there is sufficient evidence to show that all relevant aspects of the application have been assessed;
c
written responses to type 3 and 4 issues and requests for supplementary information have been received from the applicant;
d
type 3 and 4 issues were all resolved or where not resolved, together with clearly documented reasons;
e
the assessments and decisions taken are documented, fair and consistent;
f
the conclusions reached are based on the assessment files and reflect the assessment as a whole.
2
Where it is concluded that the process for the assessment of the application has been correctly applied, a confirmation of the correct application of paragraph 1, accompanied by any comments, shall suffice.
3
Where it is concluded that the process for the assessment of the application has not been correctly applied, then reasons for reaching that conclusion shall be clear and specific.
4
In conclusion of the assessment activities, the authorising entity shall complete an assessment file covering paragraphs 2 or 3 on the basis of the assessment files issued in accordance with Article 39(5) and Article 40(6).
5
The authorising entity shall provide documented reasons for its conclusion in the assessment file referred to in paragraph 4.

Decision for the authorisation or the refusal of the application
Article 46
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.