The Contact Us form (withing each FAQ item) should be used to submit general questions concerning the applicable legal framework and the certification/authorisation procedure. Specific questions about future or on-going applications are out of the scope of the Contact Us webform and will not be addressed by the Agency. We advise you to ask to the appointed Project Manager of the authorising entity in such case (NSA or ERA). You can always request a Chargeable Service to the Agency. Further details on chargeable services can be found in the website via the following link.
The Contact Us form should be used to submit general questions concerning the applicable legal framework and the certification/authorisation procedure.
Specific questions about future or on-going applications are out of the scope of the Contact Us webform and will not be addressed by the Agency.
We advise you to ask to the appointed Project Manager of the authorising entity in such case (NSA or ERA).
You can always request a Chargeable Service to the Agency. Further details on chargeable services can be found in the website via the following link.
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:
the parameters affecting technical compatibility between the vehicle and the area of use have been changed,
the overall safety level may be adversely affected by the change, or
the relevant TSI requires it.
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 of the railway undertaking’s safety management system arrangements
the assessment of the safety risks relating to the use of the vehicle (the vehicle is undergoing testing because it has not yet been subject to all the processes needed to confirm that it meets the essential requirements)
the running of tests on the network in accordance with the infrastructure manager’s arrangements for tests on the network.
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.
Where the Agency is authorising entity it is required to consult the concerned national safety authority for the area of use, who checks aspects of the application applicable to the area of use that falls within its Member State.
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.
The applicant can choose one of the official languages of the Union for preparing and submitting the application and the file accompanying the application. As a general rule, a patchwork approach to languages, where different parts of the file are submitted in different official languages of the Union, will not be accepted. However, when the team performing the assessment has the necessary language skills to assess efficiently the application, or when the applicant provides proper translations to the language chosen for the application, the Agency may accept several official languages of the Union within the file accompanying the application.
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:
facilitating early contact between the parties
developing the relationship between the authorising entity, the concerned national safety authorities for the area of use and the applicant
verifying that the applicant has been provided with sufficient information so that it knows what is expected from it, including establishing the scope of the application
reaching a common understanding for the interpretation of the applicable rules (in particular transition clauses) to establish the baseline for the applicable rules and
making it clear how the vehicle authorisation process will be conducted and how decisions will be made.
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 new holder of the vehicle type authorisation is primarily responsible for the new design and the new vehicle type as a whole
The initial holder of the vehicle type authorisation remains liable for the unchanged parts of the design and the new holder of the vehicle type authorisation is liable for the changes it introduces and the interfaces with the unchanged parts of the design of the vehicle type
The new holder of the vehicle type authorisation is solely responsible for the configuration management of the new 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.
No, type authorisation only applies to vehicles. Mobile subsystems (rolling stock and control-command and signalling) are placed on the market without authorisation.
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.
ERATV is a register of vehicle type authorisations, meaning the “digitalization” of the issued authorisation. Authorisations of vehicles (be it for placing in service or for placing on the market) are out of the scope of ERATV.
For vehicles authorised before Directive 2008/57/EC, there is normally no type authorisation (in some cases, no authorisation at all), and therefore it is not possible to record them in ERATV. Please notice as well that vehicle type authorisation is a concept that appeared (legally speaking) for the first time in the European legal framework in Directive 2008/57/EC. In a few MSs, the concept already exists before that, and it´s described in the relevant national legal framework.
It is still possible to perform changes (new authorisation) or extend the area of use of vehicles that do not have a type authorisation (and therefore no entry in ERATV), but are authorised or deemed authorised. Grandfather rights are preserved, unless otherwise stated in an explicit way in the TSIs.
Fur such old vehicles, there is no holder of the vehicle type authorisation. Therefore a new type shall be created, following the change or the extension of the area of use. The applicant for the new authorisation or for the extension of the area of use will become the holder of the vehicle type authorisation for the new type. The new type shall then be registered in ERATV, under the exceptional mode, as the values for some of the parameters not impacted by the change or by the extension of the area of use will be unknown.
Please notice that it is not possible to apply for authorisation for placing on the market of vehicles in conformity to type where a type does not exist or is not valid. This should be no problem for old vehicles, as any validity of a potential type authorisation would be lost (principle of not allowing the placing on the market of new vehicles conforming to an old design non-TSI compliant after 2017).
In the event of a change to a vehicle type and where there is a new applicant that becomes the holder of the vehicle type authorisation for a new vehicle type based on an existing vehicle type:
The new holder of the vehicle type authorisation is primarily responsible for the new design and the new vehicle type as a whole
The initial holder of the vehicle type authorisation remains liable for the unchanged parts of the design and the new holder of the vehicle type authorisation is liable for the changes it introduces and the interfaces with the unchanged parts of the design of the vehicle type
The new holder of the vehicle type authorisation is solely responsible for the configuration management of the new vehicle type.
If the decision has been already taken before the relevant date (be it the decision that there is no need for a new authorisation, be it the authorisation decision), the file is considered to be closed, and there is no need to handover the file to the new regime.
For those cases where the decision by the MS/NSA on whether there is a need for a new authorisation or not has not been taken before the relevant date, there is a need to fulfil the requirements of the Directive (EU) 2016/797 and the Regulation (EU) 2018/545. The applicant needs to assess whether there is a need or not for a new authorisation, and if need be, submit an application through OSS. The Authorising Entity shall manage this application through the OSS.
OSS is an IT tool to support the process of application, assessment of the application and delivery of the authorisation. It is not to be used for other purposes. If there is no need to apply for an authorisation, there is no need to use the OSS.
There are a number of issues here. To begin with, there is no direct link between the need or not for a new authorisation and the need to create a new type or a variant of an existing type. When the entity managing the change is the holder of the vehicle type authorisation, it can decide whether to create a new type or a variant of an existing type, this is an administrative decision. In both cases, the changed vehicle and/or vehicle type will need a new authorisation.
New types are generally need if a manufacturer creates from new a railway vehicle (namely, new design). They may decide to divide this new design into different models in which case they can either have different types of each model or have one type with a number of variants.
A new type may also be needed as a result of modifications, although again it may be possible to create a variant of an existing type to manage this.
Finally, a new type will be necessary in almost all cases where the entity managing a change is not the holder of the existing vehicle type authorisation. Only changes classified according to Article 15(1)(a) of Regulation (EU) 2018/545 will not require a new authorisation.
Even in the case of a vehicle which has no type associated to it (which is normally the case for vehicles authorised before Directive 2008/57/EC) and where no other changes are required in the vehicle and/or vehicle type in order to be compatible with the extended area of use, there is a need to apply for an authorisation for the extended area of use, pursuant to article 21(13) of Directive (EU) 2016/797.
The ‘area of use’ is a basic design characteristic, following Article 48(c) of Regulation 2018/545. Therefore, an extension of the area of use without changes in the design will require:
an authorisation for the extended area of use
the creation of a new type and
the registration of the new type in ERATV, covering only the extension of the area of use.
If there is a need to make changes in the design in order to make it compatible with the extended area of use (e.g. new Class B signalling system), the entity managing the change may need to apply for both a new authorisation (if the criteria or Article 21(12) of Directive (EU) 2016/797 are triggered) and an extension of the area of use. Only the elements of the design that are changed, their interfaces with the unmodified parts and the technical compatibility with the networks to which the area of use is to be extended should be checked.
in assessing the requirements capture process (that shall be performed always by the applicant) for the essential requirement safety and the safe integration between subsystems of the changed vehicle and its interfaces with the unchanged parts; this includes the process followed by the applicant to take the decision on whether a change has the potential to adversely impact safety or not
when the nature of the changes require the application of the Regulation (EU) 402/2013 for a significant change and/or
The assessment body does neither perform the risk assessment required in Annex I of Regulation (EU) 402/2013 for risk assessment nor provide advice or solutions that could compromise its independence. The proposer is responsible for carrying out all the risk assessment and risk management activities specified in Regulation (EU) 402/2013.
The role of the assessment body is to:
Give the assurance that the proposer’s risk assessment and risk management process is systematic and permits it to:
Capture (i.e. identify), understand, analyse and appropriately mitigate all reasonably foreseeable hazards which are associated to the vehicle under assessment and
Identify systematically and exhaustively all the necessary safety related application conditions for the safe integration of the vehicle within the infrastructure and the safe operation and maintenance of the vehicle. Those safety related application conditions are to be included in the file accompanying the application for authorisation.
Form an expert judgement on the correct application of the risk assessment process of Regulation (EU) 402/2013 and on the suitability of the results.
Assessment of applications is a process check and not a detailed examination of technical matters already sighed off by someone else (e.g. conformity assessment bodies or assessment body in the meaning of the Common Safety Methods on risk evaluation and assessment). If it becomes apparent that because of delays in managing the process there will be issues around timing then ERA will utilise its contingency measures (e.g. increasing the size of the team). If the issues are beyond the control of ERA then there will be a discussion with the applicant about the best way to proceed.
The use of the one-stop shop does not prevent other means of contact, such as phone calls, video conferences, face to face meetings etc. This is to be agreed between the applicant and the authorities concerned with the area of use, in particular, during pre-engagement (which is voluntary for the applicant).
For each notification the entity managing the change shall request to the Agency the creation of a workspace where the documentation can be uploaded. To do so, the template shall be filled in and submitted as an attachment to the Contact us form available on the website of the Agency, selecting “Notification 16.4” as “Topic of my request”.
In case you do not have yet an account in the ERA SharePoint environment, an account will be created and you will receive further instructions on the process to be followed.
Once the Agency receives your request, it will create a dedicated folder for your notification in the ERA SharePoint environment with a notification case reference. You will receive an email containing the URL of the folder for your notification.
In that dedicated folder you will upload the notification 16.4 form and all the information supporting your notification.
Once you have uploaded all the information supporting your notification into the relevant folder, access the notification folder, click on the button “i” (to open the details pane) and press the submit button at the bottom of the details pane. From this moment you will not be able to edit your notification anymore and the Agency is informed of the notification submission.
The Agency will assess the notification submitted and may exchange requests or information with the entity managing the change via e-mail.
During the assessment you will still have access to the notification and ERA will upload documents (like the decision) to the notification folder. You will also be informed when a document is added to the notification file.
In case you have questions about your notification, either contact the appointed Project Manager for your notification or use the Contact us form (selecting “Vehicle Authorisation” as “Topic of my request” and providing the notification case reference in the text of your question).
Any folder for a notification not submitted as specified in step 5 within 6 months of the “3.2. Estimated date of submission of the notification” (below) may be deleted.
It is not necessary to use the issues log for all the questions occurring during the assessment of an application.
The purpose of the issues log is:
to facilitate the tracking of the resolution of issues (ensuring that all issues are resolved before delivering the decision),
to alert the various actors on a specific problem that may affect their work,
to keep the traceability of the resolution of an issue (how it was resolved?), and
to facilitate the creation of the completeness check and the assessment report by attaching in these reports the main issues discovered.
In practice all communications do not have to go through the issues log and other communication channels can still be used (e.g. phone or email). However, a user is expected to create an issue in the issues log in the following cases:
the issue needs tracking,
evidence is to be added to the application file, or
there is an impact other parties (e.g. the applicant, another authority) or on the application file.
Note that nothing prevents the user to create an issue later on if this appears to be relevant.
Another aspect relates to the formulation of the issue. An issue may contain several questions but in that case, all questions need to be of the same type, have the same due date, etc. and the issue can only be closed when all questions are answered. It is left at the discretion of the user (and ultimately the project manager) to organise this in the most appropriate manner depending on the needs of the project.
Issues shall be created by users as soon as they evaluate that one of the purpose is met.
See also:
Explanations of Art. 41 (categorisation of issues) and 42 (justified doubt) of the Implementing Regulation (EU) 2018/545 in the Guidelines
If you don't find the answer to your question, please contact us directly:
Various documents are required for the authorisation. Such documents shall be provided in the documentation supporting the application. In case of positive decision related to the application the issuing authority has the obligation to check that the concerned documents are present in ERADIS. In case they are not, the decision will be positive but the authorisation will not be delivered to the applicant (pending the documents are uploaded).
The list of documents to upload in ERADIS are listed in the ERADIS homepage.
Applicant are free to organize their documentation according to their needs. The folder structure proposed for the documentation is a guidance. However respecting it renders the elaboration of the mapping tables easier and it is therefore encouraged. If the structure is not followed it is highly probable that it will take more time to create the mapping table. In some cases the applicant may want to provide sub-folders; in such case a zip file (of the sub-folders) should be uploaded in the documentation and the reference(s) in the mapping table(s) shall contain the location and the filename in the zip file.
See also:
“Guidance for annex I” (Content of the application) [of the Implementing Regulation (EU) 2018/545] in the Guidelines
Templates and checklists can be used to support the work of the actors during the assessment. These templates and checklists are documents to fill in with usual office suite tools and to upload in the OSS as attachments to the various reports (mainly completeness check, detailed assessment, conclusion, decision and authorisation). The templates and checklists are made available to the users through the templates folder in the library.
If you don't find the answer to your question, please contact us directly:
The authorisation case once saved can hardly be changed. To select correctly the authorisation case please read carefully the application guide on vehicle authorisation (article 14). If you select a wrong authorisation case, you will probably need to recreate your application from scratch. Alternatively you can delete the uploaded documents from the documentation and empty the content of the mapping tables. The selection of the authorisation case triggers the creation of the folder structure for the documentation as well as the definition of the authorization details to provide.
The documentation to provide depends on the real case. The implementing regulation (EU) 2018/545 details in annex 1 the content expected per authorisation case. The application guide details further this annex 1 (especially the technical file and the requirements capture). Depending on your real case some folder may be left empty. OSS does not constrain on providing file in each folder. It is the responsibility of the applicant to provide the appropriate documentation.
OSS allows you to define the language of the user interface in your profile. The language in which you want the authorising entity to deliver the authorisation is a separate field in each application form. The two may be differentiated depending on your need. The language to use during the processing of the application is described in the implementing act and in the application guide (article 10).
The type / variant(s) / vehicle(s) in the authorisation details shall be carefully created: once the application is submitted it is not possible to add type / variant(s) / vehicle(s).
The definition of the area of use consists in selecting the Member State(s) where the vehicle will be authorized and the network(s) in these Member State(s). There is also the possibility to select the border stations in the neighbouring Member State(s). The allowed values for the networks and the border stations are defined by each Member State. Each concerned NSA shall provide the exact possible values. Please refer to the NSA website or contact the NSA to get the list of possible values for each information. The value “Whole EU” should be selected only for vehicles where no national technical rule are applicable.
The selection of the authorising entity is essential for the processing of your application. If the area of use of your vehicle authorisation concerns more than one Member state, the authorising entity shall be the Agency; if the area of use is limited to one Member State you can choose between the NSA and the Agency. The OSS does not allow the choice of the NSA as authorizing entity in one application when the area of use covers more than one Member State. In case of wrong selection of the authorising entity, the application will be rejected and a new application will be required.
The mapping tables provide guidance to the assessors about where the aspects to assess are documented. The references shall be detailed and precise enough to allow the assessor to be efficient in its assessment. Vague or insufficient mapping tables will trigger issues and may be a cause for incompleteness.
If you don't find the answer to your question, please contact us directly:
Upon request and under the sole responsibility of the holder of the vehicle type authorisation, the Agency can publish new versions in ERATV compiling existing versions of a vehicle type or of a variant of a vehicle type, when these versions were published by the Agency. This also applies to vehicle types authorised following an extension of the area of use, when the result of the extension is a new vehicle type pursuant to Article 14(2).
This is necessary for applying for the authorisation of vehicles in conformity to an already authorized type when the target area of use (in case of types or versions authorized following an extension of the area of use) or the design (in case of versions published in ERATV following changes classified pursuant to Article 15(1)(c) of Regulation (EU) 2018/545 or addition of ESCs/RSCs), while covered by several ERATV entries, is not matching any entry in ERATV for the existing versions.
The result of the compilation will be a new entry in ERATV. The type ID will be assigned as if it was a new version of the precedent type/variant. This new version will compile the values for the different parameters (including coded and non-coded restrictions) of the existing entries in ERATV corresponding to the types/versions that will be compiled. In the comments section, it will describe both the preceding type/variant and the different types/versions compiled (including their type IDs).
The compilation of types/versions is not an authorisation, but a service output that consolidates into a new ERATV record the information from existing records in ERATV.
Further details can be found in guidance to Article 50 of the Implementing Regulation (EU) 2018/545, available at the website of the Agency.
In order to request the creation of a compiled version, the holder of the vehicle type authorisations of all types/versions to be compiled needs to submit to the Agency a request for the creation of a draft type in ERATV using this template (TEM_VEA_092) and send it by email to servicedeskera [dot] europa [dot] eu (servicedesk[at]era[dot]europa[dot]eu) with subject “Request for the compilation of existing versions”.
When the draft type for the compiled version is ready in ERATV and you have been granted access to it as an auxiliary user, you will be informed by email. You can then provide the technical details (steps 2 and 3) for the compiled version directly in ERATV, and inform the Agency, that will review the data, fill-in step 4 and publish the entry for the compiled version in ERATV.
The request shall be submitted by the holder of the vehicle type authorisation of the different types/versions to be compiled
The Agency can only perform the compilation for types/versions published by the Agency
Compilation of types/versions with transitions between neighbouring MSs which were not covered by the existing authorisations is not possible; the cross-border operations in terms of transitions between neighbouring MSs shall be limited to those already covered by the existing authorisations;
When submitting an application through the OSS, the applicant must provide the concerned EC certificates and EC declarations through the OSS, taking into account the scope of the application (e.g. in case of new authorisation, only the EC certificates and EC declarations of Interoperability Constituents impacted by the change need to be submitted). Before submitting the application, the applicant must ensure that all the EC certificates and EC declarations are uploaded in ERADIS.
During the assessment of an application for authorisation, the authorising entity shall perform several checks on the EC certificates and EC declarations, such as consistency between the application and ERADIS/ERATV, consistency between the EC certificates mentioned in the EC declarations and the actual EC certificates submitted in the application etc.
In order to reduce streamline the assessment process, applicants are kindly requested to fill-in this template (TEM_VEA_061) and include it in the application for authorisation before submitting it.
When submitting an application for a vehicle type authorisation through the OSS, applicants have the legal obligation to indicate the identified conditions for use of the vehicle and other restrictions (point 14 of Annex I of Regulation (EU) 2018/545), in terms of coded and non-coded restrictions. In addition to providing this information through the OSS, applicants can are kindly requested to fill-in this template (TEM_VEA_062) and upload it to the library of the concerned OSS application (folder “Other documents”).
See also:
Explanations of Article 20 of the Implementing Regulation (EU) 2018/545 in the Guidelines
Technical document ERA/TD/2011-09/INT List of harmonised and national restriction codes
In order to request a modification of a record in ERATV in case of changes to an already authorised vehicle type that are classified by the entity managing the change pursuant to Article 15(1)(b) of Regulation (EU) 2018/545, the holder of the vehicle type authorisation needs to submit a request for modification. When the Agency is the authorising entity, please use this template (TEM_VEA_095) and follow the instructions within.
Please note that:
Only the holder of the vehicle type authorisation can request modifications in the concerned ERATV record.
The Agency cannot modify ERATV records created by NSAs following type authorisations issued by NSAs. The Agency can only modify ERATV records related to vehicle type authorisations issued by the Agency.
The modifications in an ERATV record for this category of changes should be limited to the references to the EC certificates (parameters 2.2 and/or 3.1.3.1.4 / 3.1.3.X.5). As a consequence:
Modifications in the values for the technical parameters in section 4 of the concerned ERATV record are not allowed.
Modifications in the conditions for use of the vehicle and other restrictions as a result of a 15(1)(b) change should be analysed pursuant to Article 15(1) of Regulation (EU) 2018/545, independently of the change itself.
Modification of the reference to the written declaration covering the requirements capture process (parameter 3.1.3.1.7 / 3.1.3.X.8) is only allowed in case of editorial changes in the declaration. If the declaration is changed due to a new assessment report issued by the AsBo, it is not allowed to update the ERATV record.
1. Submit to the authorising entity (NSA or Agency) a request for the creation of a draft type in ERATV before applying for the authorisation. When the Agency is the authorising entity concerned, please use this template (TEM_VEA_092) and send it by email to servicedeskera [dot] europa [dot] eu (servicedesk[at]era[dot]europa[dot]eu) with subject:
“Request for draft ERATV type” in case of creation of draft entries in ERATV related to a vehicle type authorisation to be issued by the Agenc;y
“Request for the publication of a version following 15(1)(c) changes” in case of creation of a draft entry for a version resulting from a change classified pursuant to article 15(1)(c) of Regulation (EU) 2018/545
2. You will be informed by email when you have access to the draft type as an auxiliary user. At this moment, you can provide the technical details (steps 2 and 3) directly in ERATV. The draft type contains the TYPE ID to use in the authorisation application. More information about ERATV can be found here.
3. When your draft type is ready in ERATV print it into a PDF file (or export it to Excel), fill-in this template (TEM_VEA_060) and upload both files into the documentation of your application in the OSS (folder “Information required for ERATV (18.13) of the library).
4. In case of requests for publication of versions following changes categorised pursuant to Article 15(1)(c) of Regulation (EU) 2018/545, please inform the Agency about the completion of the draft entry for steps 2 and 3; the Agency will fill in step 4 and publish the entry in ERATV.
Please contact the NSA directly to get the details of the national procedure to request for the creation of an entry in ERATV when:
the NSA is going to be the authorising entity, or
in case of the creation of a version following a change categorised pursuant to article 15(1)(c) of Regulation (EU) 2018/545, the area of use concerns only one Member State and the NSA was the authorising entity that issued the authorisation of the related vehicle type or variant.
The Article 7(4) of the Regulation (EU) 2018/545 places the obligation for NSAs to share with the Agency and other NSAs information resulting from return of experience related to technical and operational matters that may be relevant for the issuing of a vehicle type authorisation and/or vehicle authorisation for placing on the market. This is not limited to safety, but covers all possible aspects impacting the issuing of an authorisation.
Article 8(2) of Regulation (EU) 2018/545 requires the Agency to establish a procedure for the exchange of such information.
The Safety Information System (SIS) is the working tool and an information channel for the exchange of safety relevant information between NSAs and NIBs. Part of this information may be relevant for the issuing of authorisations with regards to Article 7(4) and 8(2) of Regulation (EU) 2018/545.
In the future, the Information Sharing System (ISS) may take over SIS and cover all aspects (not only safety). Meanwhile, NSAs can report to the Agency by sending an email to following functional mailbox:
VA_RoEera [dot] europa [dot] eu (VA_RoE[at]era[dot]europa[dot]eu)
The Agency will analyse the information received in the functional mailbox with a view to propose how this information shall be considered as one or more of the following:
Deficiency in a TSI;
Future amendment of a TSI and/ or the TSI application guide;
Amendment to the “Guidelines for the practical arrangements for the vehicle authorisation process”;
Amendment to the “Guidelines for issuing vehicle authorisation for placing on the market and vehicle type authorisation” (GUI_VEA_001);
Amendment of the procedure PRO_VEA_001 and/or any of the related templates and/or work instructions;
Proposal for amendment of a legal text (e.g. Directive (EU) 2016/797, Regulation (EU) 2018/545 etc.);
No action required, but to be considered in the process of analysing an application/request/notification, and/or
No action required (for information purposes only).
The analysis will be documented and shared with all NSAs by means of the following log:
New entries into the SIS system will be introduced by the Agency in the log referred above, and will be treated as any other information received in the framework of Article 8(2) of Regulation (EU) 2018/545.
