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As part of the assessments pursuant to points (a) and (b) and in the case of justified doubts, the Agency or the national safety authorities may request that tests be conducted on the network. In order to facilitate those tests, the national safety authorities involved may issue temporary authorisations to the applicant to use the vehicle for tests on the network. The infrastructure manager shall make every effort to ensure that any such test takes place within three months of the request of the Agency or the national safety authority.

6. Within one month of receipt of the applicant's request, the Agency shall inform the applicant that the file is complete or ask for relevant supplementary information, setting a reasonable deadline for the provision thereof. With regard to the completeness, relevance and consistency of the file, the Agency may also assess the elements specified in point (d) of paragraph 3.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 51(3). They shall take into account the experience gained during the preparation of the cooperation agreements referred to in paragraph 14 of this Article.

10. Vehicle authorisations for placing on the market shall state:

(a) the area(s) of use;

(b) the values of the parameters set out in the TSIs and, where applicable, in the national rules, for checking the technical compatibility between the vehicle and the area of use;

(c) the vehicle's compliance with the relevant TSIs and sets of national rules, relating to the parameters referred to in point (b);

(d) the conditions for use of the vehicle and other restrictions.

11. Any decision refusing the vehicle authorisation for placing on the market or excluding part of the network in accordance with a negative assessment as referred to in paragraph 7 shall be duly substantiated. The applicant may, within a period of one month from receipt of the negative decision, request that the Agency or the national safety authority, as appropriate, review the decision. The Agency or the national safety authority shall have two months from the date of receipt of the request for review in which to confirm or reverse its decision. If the negative decision of the Agency is confirmed, the applicant may bring an appeal before the Board of Appeal designated under Article 55 of Regulation (EU) 2016/796. If the negative decision of a national safety authority is confirmed, the applicant may bring an appeal before an appeal body in accordance with the national law. Member States may designate the regulatory body referred to in Article 55 of Directive 2012/34/EU for the purpose of this appeal procedure. In that case, Article 18(3) of Directive (EU) 2016/798 shall apply.

12. In the event of renewal or upgrading of existing vehicles which already have a vehicle authorisation for placing on the market, a new vehicle authorisation for placing on the market shall be required if:

(a) changes are made to the values of the parameters referred to in point (b) of paragraph 10 which are outside the range of acceptable parameters as defined in the TSIs;

(b) the overall safety level of the vehicle concerned may be adversely affected by the works envisaged; or (c) it is required by the relevant TSIs.

13. Where the applicant wishes to extend the area of use of a vehicle which has already been authorised, it shall supplement the file with the relevant documents referred to in paragraph 3 concerning the additional area of use. The applicant shall submit the file to the Agency, which shall, after following the procedures laid down in paragraphs 4 to 7, issue an updated authorisation covering the extended area of use.

16. This Article shall not apply to freight wagons or passenger coaches which are in shared use with third countries, the track gauge of which is different from that of the main rail network within the Union and authorised in accordance with a different vehicle authorisation procedure. The rules governing the procedure for authorisation of such vehicles shall be published and notified to the Commission. The conformity of those vehicles with the essential requirements of this Directive shall be ensured by the railway undertaking concerned in the context of its safety management system. The Commission, on the basis of the report by the Agency may give an opinion on whether such rules are compliant with the objectives of this Directive. If such rules are not compliant, the Member States concerned and the Commission may cooperate in order to lay down appropriate actions to be taken, involving relevant international bodies, if necessary.

1. The applicant shall place a vehicle on the market only after having received the vehicle authorisation for placing on the market issued by the Agency in accordance with paragraphs 5 to 7 or by the national safety authority in accordance with paragraph 8.

2. In its application for a vehicle authorisation for placing on the market, the applicant shall specify the area of use of the vehicle. The application shall include evidence that the technical compatibility between the vehicle and the network of the area of use has been checked.

3. The application for a vehicle authorisation for placing on the market shall be accompanied by a file concerning the vehicle or vehicle type and including documentary evidence of:

(a) the placing on the market of the mobile subsystems of which the vehicle is composed in accordance with Article 20, on the basis of the ‘EC’ declaration of verification;

(b) the technical compatibility of the subsystems referred to in point (a) within the vehicle, established on the basis of the relevant TSIs, and where applicable, national rules;

(c) the safe integration of the subsystems referred to in point (a) within the vehicle, established on the basis of the relevant TSIs, and where applicable, national rules, and the CSMs referred to in Article 6 of Directive (EU) 2016/798;

(d) the technical compatibility of the vehicle with the network in the area of use referred to in paragraph 2, established on the basis of the relevant TSIs and, where applicable, national rules, registers of infrastructure and the CSM on risk assessment referred to in Article 6 of Directive (EU) 2016/798.

That application and information about all applications, the stages of the relevant procedures and their outcome, and, where applicable, the requests and decisions of the Board of Appeal, shall be submitted through the one-stop shop referred to in Article 12 of Regulation (EU) 2016/796. Whenever tests are necessary in order to obtain documentary evidence of the technical compatibility referred to in points (b) and (d) of the first subparagraph, the national safety authorities involved may issue temporary authorisations to the applicant to use the vehicle for practical verifications on the network. The infrastructure manager, in consultation with the applicant, shall make every effort to ensure that any tests take place within three months of receipt of the applicant's request. Where appropriate, the national safety authority shall take measures to ensure that the tests take place.

4. The Agency or, in the case of paragraph 8, the national safety authority shall issue vehicle authorisations for placing on the market or inform the applicant of its negative decision within a predetermined, reasonable time, and in any case within four months of receipt of all relevant information from the applicant. The Agency, or, in the cases provided for in paragraph 8, the national safety authority, shall apply the practical arrangements on the authorisation procedure to be established in an implementing act, as referred to in paragraph 9. Those authorisations shall allow vehicles to be placed on the Union market.

5. The Agency shall issue vehicle authorisations for placing on the market in respect of vehicles having an area of use in one or more Member States. In order to issue such authorisations, the Agency shall:

(a) assess the elements of the file specified in points (b), (c) and (d) of the first subparagraph of paragraph 3 in order to verify the completeness, relevance and consistency of the file in relation to the relevant TSIs; and (b) refer the applicant's file to the national safety authorities concerned by the intended area of use for assessment of the file in order to verify its completeness, relevance and consistency in relation to point (d) of the first subparagraph of paragraph 3 and to the elements specified in points (a), (b) and (c) of the first subparagraph of paragraph 3 in relation to the relevant national rules.