Authorisation applies to vehicles and to vehicle types. A vehicle authorisation for placing on the market will always result in a vehicle type authorisation granted at the same time. A vehicle type authorisation (i.e. the design) does not necessarily require that a vehicle conforming to that type is authorised, the decision lies with the applicant.
A new vehicle type and/or vehicle must always be authorised. Where changes are made to the vehicle type and/or the vehicle, be it a change to the applicable rules sufficient to require a renewed type authorisation, a change to the design (dependent on the scale of the change) or a change to the area of use, there is a need to apply for an authorisation.
If an already authorised vehicle type and/or vehicle is changed, the extent of the changes must be analysed. A new authorisation is required if:
An unchanged vehicle requires authorisation if there is a change to the area of use.
Temporary authorisation to use the vehicle for tests on the network is only required where specified by the Member State’s legal framework. In such a case, the national legal framework should specify the process to be followed and the applicable rules.
Even where there is no requirement for temporary authorisation, the risks of operating a vehicle that is being used for tests have to be managed, which involves (in addition to a temporary authorisation where applicable):
The application is made through the One-stop shop. When the area of use is limited to one Member State the applicant chooses the authorising entity responsible for issuing the authorisation, to be either the Agency or the national safety authority for the Member State. In all cases where the authorisation is for a vehicle having an area of use covering more than one Member State the authorising entity is the Agency.
In the case of an authorisation in conformity to type, it is beneficial if the authorising entity is the same entity that issued the vehicle type authorisation.
Where the applicant has a choice of authorising entity and has made its selection, the applicant is not able to change its choice unless the initial application is terminated and the applicant triggers a new application to the other authorising entity. In such a case, the applicant has to restart the whole authorisation process from the beginning.
The legal text of the Implementing Regulation on vehicle authorisation defines the time limits applicable to processing applications. These are the maximum times, not target times, and the actual time required will be influenced by the complexity and quality of the application.
The authorising entity is required to carry out a completeness check of the application within one month. For authorisation in conformity to type the decision should also be taken within one month. For other authorisation cases a decision must be made no later than four months after acknowledging the file is complete.
This timescale may be extended if the assessment has to be suspended in order for the applicant to resolve a justified doubt. The timescale for a suspension is agreed with the applicant and is proportionate to the difficulty of providing the information requested to address the justified doubt.
If the application is for an area of use limited to one Member State and the national safety authority is the authorising entity then the provisions for language in the relevant national legal framework apply. The language policy should be indicated in the application guide produced by that national safety authority.
In other cases the application and the file accompanying the application may be submitted by the applicant in any one of the official languages of the Union. Nonetheless the Agency and the national safety authorities concerned with the area of use can request that the applicant translates parts of the file accompanying the application. In order to reduce the need for translation and to facilitate exchanges during the assessment it is recommended to use English or a commonly agreed language for the assessment of the application. When applicable the choice of language for the assessment should be made during pre-engagement.
Pre-engagement is an optional stage that comes before the submission of an application for authorisation, where the applicant submits details of its proposed application so that a baseline can be agreed at an early stage in the process of developing the application.
The benefits can include:
An application that is fundamentally deficient can be rejected during the completeness check, which takes place within one month of the receipt of the application.
An application that has not been found to be fundamentally deficient during the completeness check is then assessed by the authorising entity and concerned national safety authorities for the area of use. Any serious concern on the content of the application file, such that it needs to be amended before the authorisation decision can be made, may result in the rejection of the application if the matter is not addressed by the applicant within the assessment timeframe.
The applicant may use the one-stop shop to request a review of the decision within one month from the date of receipt. The request shall include a list of issues that have not been properly taken into consideration during the process. The review shall be concluded within two months of the date of receipt of the request.
If the review confirms a negative decision by the authorising entity, the applicant may appeal. For applications where the Agency is the authorising entity this appeal is brought before the Board of Appeal. For applications where a national safety authority is the authorising entity, the appeal is brought before the national appeal body in accordance with the national procedure.
‘First authorisation’ applies to a new vehicle type – including variants and versions – and where applicable, to the first vehicle of a new vehicle type.
‘Renewed vehicle type authorisation’ is used when the design of a vehicle type has not changed but there is a change to the applicable rules that includes a requirement for renewal of the authorisation. The scope of the authorisation is limited to the changed rules.
‘Extended area of use’ is required where the design of the vehicle has not changed but the area of use is extended.
‘New authorisation’ applies when a change has been made to an already authorised vehicle and/or vehicle type that requires authorisation. The scope of the assessment is limited to the changes.
‘Authorisation in conformity to type’ is used for a vehicle or a series of vehicles that conform to an already authorised and valid vehicle type. The authorisation is given on the basis of a declaration of conformity to that type.
The holder of the vehicle type authorisation is the person that has applied for and received the vehicle type authorisation, or its legal successor. They are responsible for the configuration management of the vehicle type.
The holder of the vehicle type authorisation is considered to be capable of managing changes to the type that do not require authorisation in accordance with the criteria set out in Article 21(12) of Directive (EU) 2016/797. Where changes are made to an authorised vehicle type that introduce a deviation from the technical files accompanying the EC declarations for verification for the subsystems, and those changes are made by someone who is not the holder of the vehicle type authorisation, then a new vehicle type shall be created and the entity managing the change shall become the applicant. If an authorisation is given that person becomes the holder of the type authorisation for the new vehicle type.
Similarly, where changes are made to an already authorised vehicle that introduce a deviation from the technical files accompanying the EC declarations for verification for the subsystems but do not require authorisation in accordance with the criteria set out in Article 21(12) of Directive (EU) 2016/797, and those changes are made by someone who is not the holder of the vehicle type authorisation, then the entity making the changes is required to notify the authorising entity of the changes that have been made. The holder of the vehicle type authorisation is not required to submit such notifications.
In the event of a change to a vehicle type where a new applicant becomes the holder of the vehicle type authorisation for a new vehicle type that is based on an existing vehicle type:
The arrangements are intended to allow people other than the original holder of the vehicle type authorisation to make changes to vehicle types and/ or vehicles. If original documentation from a previous authorisation isn’t fully available the process can still be applied in this way.
For authorisation the applicant demonstrates the compatibility of the vehicle with the networks of the area of use.
After authorisation, route compatibility is checked by evaluating vehicle data against the information from the Register of Infrastructure and/or the infrastructure manager. These are simple cross-checks. Some particularities of a network may require tests, but this should be seen as an exception
NoBos have to apply surveillance and audits of manufacturing process according to the relevant modules defined in Commission decision 2010/713/EU. The NoBo issues certificates when satisfied that the manufacturing processes and quality management system ensure that the manufactured vehicles conform to the type.
An authorisation can be suspended, revoked or amended as a safety measure. If a serious safety risk is identified by a national safety authority during supervision the authorisation can be suspended as a temporary measure. If the vehicle type (i.e. the design) is subsequently proven not to have met the essential requirements the authorisation can be revoked. Revocation is therefore an action to be taken to deal with defective design or manufacture of a vehicle type or vehicles of a vehicle type. It is not to be used in the case of failure to meet the essential requirements due to actions or inactions of the safety management system of the railway undertaking or entity in charge of maintenance (e.g. a safety management system that does not properly control maintenance leading to vehicles no longer meeting the essential requirements).
In the case of a revocation of a vehicle type authorisation, there is no automatic revocation of the vehicle authorisation for placing on the market for vehicles conforming to that type. However, the concerned vehicles should be withdrawn, meaning that they can no longer be used.