1. Demoutiez, Jean-François – Frank Leissner Stockholm, 5th December 2019
vehicle authorisation – questions and answers in the framework of the 4th Railway Package
Demoutiez, Jean-François – Frank Leissner
Stockholm, 5th December 2019

2. Question 1
Is it possible to start a new application for a vehicle at the same time as an existing application is under review, i.e. an ongoing reconstruction and then an upgrade of ETCS but handled as separate projects. Or will the last project have to wait until the previous project is finished in OSS?
This should follow a sequential approach (in order to apply for a new authorisation, there is a need to provide evidence of an existing vehicle type authorisation). However, both modifications can be covered in the same application, and will result in an unique vehicle type authorisation. On submission of the application, all the evidences required must be included in the application file (it is not allowed to submit incomplete applications).
Key message:
describe the evolution of the EU regulatory framework, this will help to understand why there was a need of technical and operational harmonization.
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3. Question 2
Is it possible that a supplier is holder of vehicle type authorization and keeper is the holder of the authorisation for placing on the market?
There is no limitation on who can apply for an authorisation in conformity to a type (the holder of the vehicle type authorisation or other). See section of the VA guidelines.
Key message:
describe the evolution of the EU regulatory framework, this will help to understand why there was a need of technical and operational harmonization.
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4. Question 3(1)
If so, what happens when changes are made later on in the life cycle - who is responsible for what? And can these two applications be handled simultaneously in the OSS but by different applicants?
This is further explained in articles 15 and 16 of Regulation (EU) 2018/545, and chapters , and of the VA guidelines.
Changes can be performed to the type and to the vehicles. The responsibility of the configuration management of the type lies with the holder of the vehicle type authorisation; the configuration management of the vehicles lies with the keeper.
A vehicle can evolve independently from the type it was originally conforming with. And the other way around: a type can evolve, and the vehicles can remain conforming to the original type (generally speaking, there is no obligation to modify the vehicles to match new types/variants/versions, this is a decision to be taken by the keeper). .
Key message:
describe the evolution of the EU regulatory framework, this will help to understand why there was a need of technical and operational harmonization.
To know more:
91/440 =
White paper:

5. Question 3(2)
If so, what happens when changes are made later on in the life cycle - who is responsible for what? And can these two applications be handled simultaneously in the OSS but by different applicants?
An entity managing the change who is not the holder of the vehicle type authorisation, in case of changes to vehicle types classified as 15(1)(b), (c) or (d) of Regulation (EU) 2018/545, must apply for a new authorisation. In case of vehicles, is it possible to use the provisions in article 16(4) of Regulation (EU) 2018/545.
An applicant is responsible for one (or more) applications for authorisation through the OSS. There cannot be two applicants for one application (due to the definition of applicant in the legal text). Each company (the one who is the holder of the vehicle type, and the one that wants to get vehicles authorised by conformity to the type but his not the holder) can submit independent applications through the OSS.
Key message:
describe the evolution of the EU regulatory framework, this will help to understand why there was a need of technical and operational harmonization.
To know more:
91/440 =
White paper:

6. Question 4
Will it be possible to apply in OSS for an Area of Use with several member states and the type test 3 results not be ready for all member states at the date of the application, or will the Project have to wait to send the application until all track tests are performed?
The application needs to be complete on submission. The applicant can submit applications for the extension of the area of use when all the evidences for the different Member States are available.
Key message:
describe the evolution of the EU regulatory framework, this will help to understand why there was a need of technical and operational harmonization.
To know more:
91/440 =
White paper:

7. Question 5
Information about handling of changes (hardware and/or software) on already homologated vehicles. Are there handled via the same contact as new vehicles? In which cases is it necessary to apply for a re-homologation? In which cases is it sufficient with information only? And in which cases no contact has to be taken for authorisation?
Changes to already authorised vehicles and/ or vehicle types are described in the articles 15 and 16 of Regulation (EU) 2018/545. Further clarifications are provided in chapters , and of the VA guidelines.
The entity managing the change is responsible to decide whether a change requires a new authorisation, based on the criteria in article 21(12) of Directive (EU) 2016/797. .
Key message:
describe the evolution of the EU regulatory framework, this will help to understand why there was a need of technical and operational harmonization.
To know more:
91/440 =
White paper:

8. See chapter 3.2.2.6 of the VA guideline..
Question 6
Who becomes "holder of the vehicle type authorisation" for the operators existing vehicles??
See chapter of the VA guideline..
Key message:
describe the evolution of the EU regulatory framework, this will help to understand why there was a need of technical and operational harmonization.
To know more:
91/440 =
White paper:

9. Question 7
Regarding the applications for vehicle authorisations, how many have chosen the supplier as "holder of the vehicle type authorisation", and which other solutions have you seen?
The Agency has received applications from entities being and not being the holder. However, in the majority of cases, the applicant for a vehicle authorisation for placing on the market in conformity with and authorised type was also the holder of the vehicle type authorisation.
Key message:
describe the evolution of the EU regulatory framework, this will help to understand why there was a need of technical and operational harmonization.
To know more:
91/440 =
White paper:

10. Question 8
Regarding the documentation that is registered in the OSS, can you guarantee that it is handled with confidentiality? Can it be "asked out" by anyone outside ERA/NSA?
Only the applicant, the ERA program managers and the ERA staff allocated to a given application, and the concerned NSAs for the area of use (if any), can have access to the file in OSS. Authorising entities and NSAs for the area of use can decide to share certain applications, by means of the role Observer in the OSS; this action needs to be performed application by application.
Regarding the access to the documentation in OSS for applications where the Agency is the authorising entity by persons/organisations not belonging to the Agency/NSAs, Regulation (EC) 1049/2001 applies.
Key message:
describe the evolution of the EU regulatory framework, this will help to understand why there was a need of technical and operational harmonization.
To know more:
91/440 =
White paper:

11. Question 9
Previously in Sweden the NSA has been very supportive regarding if a NoBo is needed for a project or not (it is not always an easy decision) and which TSI scope the NoBo should have. This has also been the case when it comes to deciding if a new approval is needed. How can we get help in these early decisions in the 4RWP?
You can request a pre-engagement, or ask the support of the Agency by means of the “chargeable services” section of the website (
Key message:
describe the evolution of the EU regulatory framework, this will help to understand why there was a need of technical and operational harmonization.
To know more:
91/440 =
White paper:

12. Question 10
Is it possible to use a functional in the OSS instead of a personal? What is your experience from the users of the OSS?
This is a decision to be taken by the applicant. The applicant needs to be legally identified (natural or juridical person), but there are no conditions regarding the contact information (phone, etc.). We have seen mostly personal addresses.
Key message:
describe the evolution of the EU regulatory framework, this will help to understand why there was a need of technical and operational harmonization.
To know more:
91/440 =
White paper:

13. Question 11
From what date can we begin to register VA pre engagement applications in the OSS?
Applying for pre-engagement is possible since 16th June There is no limitation on the date of application for pre-engagement regarding the date foreseen for the application for authorisation. However, the pre-engagement baseline has a maximum validity of 84 months.

14. What is the last date to use the "old regime" for VA?
Question 12
What is the last date to use the "old regime" for VA?
Question not very clear. Each Member State shall apply the 4th Railway Package as of transposition of the Directive (EU) 2016/797 into the national legal framework. All Member States were required to do so by 16th June 2019, allowing the possibility to delay 1 year the transposition upon notification to the European Commission. After 16th June 2020, all Member States shall have transposed the Directive, and the “old regime” will not be valid anymore. Vehicle and types authorised under the “old regime” remain authorised in the same conditions as they were authorised..

15. Question 13
Who can be "holder of the vehicle type authorisation"? What are the pros and cons for choosing the operator or the supplier? What is your experience regarding discussions on the topic related to lifecycle perspective like change management and configuration management?
There is no limitation on who can be the “holder of the vehicle type authorisation”: it is the applicant that applies for (and obtains) the vehicle type authorisation. It needs to be taken into account that being the holder gives more freedom in case of future changes to the type: changes categorised as 15(1)(a) to (c) do not require a new authorisation if you are the holder. However, if you are not the holder, while it is still possible, a new authorisation is required for changes categorised as 15(1)(b) and (c) as well.
We have seen cases where both the supplier and the RU have decided to apply in parallel, for the same design (type), in order to be able to make evolutions in the future benefiting from the added flexibility of being the holder of the vehicle type authorisation.

16. Question 14
How early can the operator apply for a pre engagement for a vehicle authorisation? Is it possible for the operator to have a meeting in the beginning of the pre engagement?
There is no limitation on the date. It´s a decision of the applicant. It is possible to have a kick-off meeting following the submission of the pre-engagement application. Actually, in the pre-engagement application, the applicant needs to include this (see article 23(L) of Regulation (EU) 2018/545).

17. Is it possible to see a list of the members of the Pool of experts?
Question 15
Is it possible to see a list of the members of the Pool of experts?
The Agency cannot distribute any personal details on the experts nominated by NSAs to be part of the Pool of Experts (PoE). NSAs have chosen not to display this information to other NSAs. The rationale behind is to protect the personal data of the nominated experts. In any case, the PoE is composed of members designated by the NSAs and are no experts coming from other companies (public or private) or independent experts.

18. In the Pool of experts, how many are fluent in Swedish?
Question 16
In the Pool of experts, how many are fluent in Swedish?
The Swedish NSA has already nominated members for the Pool of Experts (5 VA assessors & 5 SSC assessors). There are other members of the Pool of Experts fluent in Swedish (B2 and above): 4 VA assessors, 2 VA PMs, 13 SSC assessors and 10 SSC PMs. In addition to that, there is also ERA staff nominated for VA & SSC fluent in Swedish.

19. For other VA cases, it is still too early to provide figures
Question 17
What have the approximate cost been for the VA & SSC that has been delivered?
For Conformity to type VA, the average number of hours per application so far is varying mostly between 3h (authorisation of vehicles in conformity to type for subsequent applications) and 24h (authorisations in conformity to type where the applicant has no experience on the use of OSS and the 4th Railway Package legal framework); the hourly rate is 130 €.
For pre-engagement VA, the average number of hours per application is between 65 hours and 235 hours depending on the complexity of the application, the hourly rate is also 130 €.
For other VA cases, it is still too early to provide figures

20. Has anyone been denied a VA? And if "yes", on what grounds?
Question 18
Has anyone been denied a VA? And if "yes", on what grounds?
For VA, there has been some applications declared fundamentally deficient (after the 1 month legal timeframe, the applicant did not provide all the mandatory information required in the Regulation (EU) 2018/545). And some applications for which part of the area of use in the application was not included in the authorisation, because the applicant could not provide all the evidence required by the Regulation (EU) 2018/545 for the whole area of use.
Some applicants have also decided to unilaterally terminate the application due to the number of flaws highlighted by the Agency during the completeness check phase, allowing them to gain time to better prepare the application

21. Has any VA ended up in the Board of appeal yet?
Question 19
Has any VA ended up in the Board of appeal yet?
No.

22. General or specific questions, how do we contact ERA?
“Contact us” form in ERA website (
Please check FAQ section of the website ( and VA guidelines and issued lines to take: ( ) before raising a question. We find often that the topics are already clarified on one of the sources above.

23. Question 21
An example from an ongoing project: For existing Rolling stock in need for some interior refreshments that do not affect safety negatively nor basic design characteristics are according to PAVA guideline flowchart not applicable for a new approval IF you are the "holder of the vehicle type authorisation". Is it possible to assume the owner and ECM as the Holder or do we need to apply at the OSS for all our existing vehicles to become Holder?
Holder is the natural or legal person that applies for (and obtains) the vehicle type authorisation. If there is no previous vehicle type authorisation, or if there is a type authorisation but the relevant field in ERATV is not filled in, there is no holder of the vehicle type authorisation. This role cannot be sold/transferred (see chapter of the VA guideline).
Another possibility is to use the provisions in article 16(4) of Regulation (EU) 2018/545, applicable only to vehicles (not to types). See chapter of the VA Guidelines.

24. Question 22
What kind of support from ERA and Transportstyrelsen can we get in our preparation of an application for authorisation before the application is sent to OSS? Cost?
It is possible to request the support of the Agency by means of the chargeable services section of the website ( The cost depends on the nature of the service requested. A cost estimate will be provided to the requestor based on an hourly rate of 130 €/h.
For other questions not directly linked to any particular project, the “Contact us” form can be used (

25. Question 23
What’s the plan for cooperation between ERA and the other authorising entities regarding the interpretation of the directive 2016/797, PAVA, TSI and other regulations that are vital for an authorisation, to enable a unified way of authorisation? For example, Transportstyrelsen makes the interpretation that it is ok to use the TSI CCS from 2016 without a derogation from the TSI CCS 2019, but ERA seems to have another opinion. Must the authorising entities cooperate to have a common opinion or shall it depend on the authorising entity if a derogation is needed or not?
The European Commission (EC) is drafting the implementing regulation (and guidance) covering the subject of non-applications of TSIs, pursuant to article 7(5) of Directive (EU) 2016/797. The involvement of the Agency in this work stream is quite limited (providing opinion upon request of the EC).
The European Commission is also in charge of the management of changes to the legal texts (TSIs, regulations etc.). The Agency provides an opinion when requested by the European Commission.
The Agency drafts the application guides to TSIs in the framework of the working groups established for drafting the TSIs, where NSAs and sector organisations are invited and represented.
The PA VA guidelines will be reviewed taking into account the Return of Experience of the application of the 4th Railway Package. In the reviewing process, all parties involved in the drafting of the current version of the VA guideline will be involved (this includes NSAs, sector organisations etc.) and the changes will be discussed and agreed (comments process + workshops).

26. Question 24
(EU) 2018/545 Article 15.1: “will the change introduce a deviation from the technical files accompanying the EC DofV?”
How should we answer this for our year old vehicles when wanting to make them more TSI-compatible? There are no technical files nor EC DofV as defined in (EU) 2018/545 for these vehicles.
The agency will provide support on how to answer the question case by case. The target is to achieve a reasonable assurance based o the arguments provided.