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) (c. 545)

CHAPTER 7 FINAL DOCUMENTATION

Article 47 Final documentation for the vehicle type authorisation and/or vehicle authorisation for placing on the market

1. A vehicle type authorisation and/or vehicle authorisation for placing on the market shall take the form of a document containing the information referred to in Article 48 and/or Article 49.

2. The issued vehicle type authorisation and/or vehicle authorisation for placing on the market shall be assigned a unique European identification number (‘EIN’) of which the structure and content are defined and administrated by the Agency.

3. Different conditions for use of the vehicle and other restrictions when compared to those specified by the applicant in its application may be included in the vehicle type authorisation and/or vehicle authorisation for placing on the market.

4. The authorising entity shall date and duly sign the vehicle type authorisation and/or vehicle authorisation for placing on the market.

5. The authorising entity shall ensure that the decision issued in accordance with Article 46 and the full accompanying file for that decision are archived pursuant to Article 52.

Article 48 The information in the issued vehicle type authorisation

The vehicle type authorisation issued by the authorising entity shall contain the following information:

(a)

the legal basis empowering the authorising entity to issue the vehicle type authorisation;

(b)

identification of:

(i)

the authorising entity;

(ii)

the application;

(iii)

authorisation case as specified in Article 14;

(iv)

the applicant for the vehicle type authorisation;

(v)

the EIN associated to the vehicle type authorisation;

(c)

an identification of the basic design characteristics of the vehicle type:

(i)

stated in the type and/or design examination certificates;

(ii)

the area of use of the vehicle;

(iii)

the conditions for use of the vehicle and other restrictions;

(iv)

the reference, pursuant to the provisions of Article 16 of Regulation (EU) No 402/2013, including the document identification and the version, to the written declaration by the proposer referred to in Article 3(11) of Regulation (EU) No 402/2013, covering the vehicle type;

(d)

an identification of:

(i)

the vehicle type ID, in accordance with Annex II to Commission Implementing Decision 2011/665/EU(1);

(ii)

the vehicle type variants, where applicable;

(iii)

the vehicle type versions, where applicable;

(iv)

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;

(v)

the vehicle type's compliance with the relevant TSIs and sets of national rules, relating to the parameters referred to in paragraph 1(d)(iv);

(e)

reference to the EC declarations of verification for the subsystems;

(f)

reference to other Union or national law with which the vehicle type is compliant;

(g)

reference to the documented reasons for the decision referred to in Article 45(5);

(h)

date and place of the decision to issue the vehicle type authorisation;

(i)

signatory of the decision to issue the vehicle type authorisation; and

(j)

the possibility and means of appealing the decision and the relevant time limits, including information about the national appeal process.

Article 49 The information in the issued vehicle authorisation for placing on the market

The vehicle authorisation for placing on the market issued by the authorising entity shall contain the following information:

(a)

the legal basis empowering the authorising entity to issue the vehicle authorisation for placing on the market;

(b)

identification of the:

(i)

authorising entity;

(ii)

application;

(iii)

authorisation case as specified in Article 14;

(iv)

applicant for the vehicle authorisation for placing on the market;

(v)

EIN associated to the vehicle authorisation for placing on the market;

(c)

the reference to the vehicle type registration in ERATV, including the information on the vehicle type variant and/or vehicle type version, when applicable;

(d)

identification of the:

(i)

vehicles;

(ii)

areas of use;

(iii)

conditions for use of the vehicle and other restrictions;

(e)

reference to the EC declarations of verification for the subsystems;

(f)

reference to other Union or national law with which the vehicle is compliant;

(g)

reference to the documented reasons for the decision referred to in Article 45(5);

(h)

in case of an authorisation in conformity to type pursuant to Article 14(1)(e), the reference to the declaration of conformity with an authorised vehicle type, including information on the vehicle type version and/or vehicle type variant when applicable;

(i)

the date and place of the decision to issue the vehicle authorisation for placing on the market;

(j)

the signatory of the decision to issue the vehicle authorisation for placing on the market; and

(k)

the possibility and means of appealing the decision and the relevant time limits, including information on the national appeal process.

Article 50 Registration in ERATV and ERADIS

1. The ERATV shall be completed by the authorising entity using the information provided by the applicant as part of the vehicle type authorisation application. The applicant shall be responsible for the integrity of the data provided to the authorising entity. The authorising entity shall be responsible for checking the consistency of the data provided by the applicant and making the ERATV entry available to the public.

2. The authorising entity shall ensure that the European Railway Agency Database of Interoperability and Safety (‘ERADIS’) has been updated as appropriate before delivering a vehicle type authorisation and/or vehicle authorisation for placing on the market

3. For modifications pursuant to Article 15(1)(c) and 15(3), the authorising entity shall register in ERATV the new version of a vehicle type or the new version of a vehicle type variant, using the information provided by the holder of the vehicle type authorisation. The holder of the vehicle type authorisation is responsible for the integrity of the data provided to the authorising entity. The authorising entity shall be responsible for checking the consistency of the data provided by the holder of the vehicle type authorisation and making the ERATV entry available to the public.

Pending the registration of the new version of a vehicle type or the new version of a vehicle type variant, the vehicles modified to be conforming to the new version may already be operated without delay.

Article 51 Review under Article 21(11) of Directive (EU) 2016/797

1. Where the decision of the authorising entity contains a refusal or 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 the review of the decision within one month from the date of its receipt. That request shall be submitted by the applicant through the one-stop shop.

2. The request for review shall include a list of issues that, in the view of the applicant, have not been properly taken into consideration during the vehicle authorisation process

3. Any supplementary information which has been developed and filed through the one-stop shop after the date of issuing of the authorisation decision shall not be admissible as evidence.

4. The authorising entity, where applicable in coordination with relevant NSAs for the area of use, shall ensure impartiality of the review process.

5. The review process shall address the issues justifying the negative decision of the authorising entity in accordance with the applicant's request.

6. Where the Agency acts as the authorising entity, a decision to reverse or not its decision shall be subject to review in coordination with the relevant NSAs for the area of use, where applicable.

7. The authorising entity shall confirm or reverse its first decision within two months from the date of receipt of the request for review. That decision shall be communicated to the relevant parties through the one-stop shop.

Article 52 Archiving of a decision and the full accompanying file for the decision issued in accordance with Article 46

1. The decision and the full accompanying file for the decision issued in accordance with Article 46 shall be retained in the one-stop shop for at least 15 years.

2. The full accompanying file for the decision of the authorisation entity issued in accordance with Article 46 shall include all documents used by the authorising entity and the assessment files of the concerned NSAs for the area of use.

3. After the expiry of the retention time set out in paragraph 1, the decision given in accordance with Article 46 for the issue of a vehicle type authorisation and/or a vehicle authorisation for placing on the market, and its full accompanying file shall be moved to a historical archive and kept for a period of five years after the termination of the service life of the vehicle, as recorded in the register referred to in Article 47 of Directive (EU) 2016/797.

(1)

Commission Implementing Decision 2011/665/EU of 4 October 2011 on the European register of authorised types of railway vehicles (OJ L 264, 8.10.2011, p. 32).