The authorisation process aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where technically and economically feasible alternatives are available.
The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.
Your application should provide sufficient information to enable us to determine whether you meet the requirements for authorisation namely that you are ready, willing and organised to comply with the standards of the regulatory system. We expect you to provide such further information as we reasonably consider necessary to enable us to determine the application or, to decide whether to give consent to the PRA (where you have applied to the PRA). If substantive changes are made to an application after it has been submitted which indicate that you are not ready, willing and organised, Authorisations may ask you to consider withdrawing the application and re-applying to provide you with an opportunity to address the issues raised.
It may take you some time to gather all the information needed for your application. Before getting started, check that the services you intend to carry on are regulated activities that require our authorisation.
Whilst you are waiting for your application to be allocated, we would encourage you to read our Authorisations pages, and familiarise yourself with the information that you need to provide when applying for authorisation. Where there are any gaps in your application, we will likely consider it incomplete. Please be aware that incomplete applications will take longer to assess.
The information required depends on the application process type that you will be following (authorisation, registration, recognition and/or endorsement) and the type of benchmarks that you will be administering (critical, significant, non significant, commodity benchmarks, interest rate benchmarks and/or regulated data benchmarks).
The new application will be assessed in the same way as any other new authorisation application, so you should make sure you have read our 'How to apply for authorisations' pages, and have everything ready for assessment when you submit your application.
In return, we offer you the commitments listed below. These commitments cover all types of application made for authorisation or to vary permissions. The same principles also cover all other types of application for authorisations which are not routinely completed in under a month.
Before a new or modified railway vehicle is permitted to operate on the EU railway network it must be authorised. An authorisation is granted for a vehicle and/or vehicle type (vehicle type authorisation) or for individual vehicles that conform to an already authorised vehicle type (vehicle authorisation for placing on the market).
The authorisation process allows the authorising entity to achieve a reasonable assurance that the applicant and the other entities involved in the design, manufacture, verfication and validation of the vehicle and/or vehicle type have fulfilled their obligations and responsibilitites, in order to ensure that the vehicle and/or vehicle type conforms to the applicable laws.
A vehicle and/or vehicle type authorisation is valid for a defined area of use, i.e. a network or networks within one or more Member States where the vehicle may be used. A further authorisation is required if changes are made to the area of use (extension of the area of use).
The Agency issues decisions in regards to the need for an authorisation when changes to an already authorised vehicle (or series of vehicles) are notified to ERA, as authorising entity, by an entity not being the type authorisation holder under Art. 16(4) of Regulation (EU) 2018/545.
The applicant for vehicle authorisation is the natural or legal person requestion an authorisation. The law does not impose a restriction on who can play the role of applicant: it can be a railway undertaking, an infrastructure manager, a manufacturer, an owner or a keeper.
Applicants should read the Commission Implementing Regulation establishing practical arrangements for the authorisation process and the related ERA guidance, which provides information about the legislation, application process and what is required from the applicant.
All applications for authorisation of a vehicle and/or vehicle type must be electronically submitted through the One-Stop Shop (OSS).This includes vehicles and/or vehicle types to be authorised for the first time (new design), changes to already authorised vehicles and/or vehicle types, extensions of the area of use, vehicles in conformity to an already authorised type and renewed vehicle type authorisation.
All decisions following an application for authorisation of a vehicle type or a vehicle can be found in the One-Stop Shop (OSS). The applicant can only access information relating to its own applications.
After its authorisation the vehicle type information is made publically available through the European Register of Authorised Vehicle Types (ERATV). Certain documents forming part of the authorisation process are also made publically available through the European Railway Agency Database of Interoperability and Safety (ERADIS).
Transitional provisions apply in the case where a National Safety Authority (NSA) recognises that it will not be able to take its decision over the issue of a vehicle (type) authorisation in accordance with Directive 2008/57/EC before either 16 June 2019 or, 16 June 2020 in respect of those Member States that have notified the Agency and the Commission in accordance with Article 57(2) of Directive (EU) 2016/797 or, 31 October 2020 in respect of those Member States that have notified the Agency and the Commission in accordance with Article 57(2a) of Directive (EU) 2016/797.
In such a case, the NSA has to promptly inform the applicant and the Agency. The applicant is requested to submit, from 16 February 2019, a revised application through the One-Stop Shop and the vehicle (type) authorisation will be issued by the selected authorising entity (i.e. the Agency or the relevant NSA).
The decisions issued by the Agency between 16 June 2019 and 31 October 2020 should exclude the network(s) of any Member States having not yet transposed Directive (EU) 2016/797. However, a vehicle (type) authorisation issued by the Agency should be recognised as equivalent to a first authorisation whilst the NSA should issue an additional authorisation in accordance with Directive 2008/57/EC.
Freight wagons with an authorisation for placing on the market should be recognised as equivalent to vehicles with an authorisation for placing into service according to Directive 2008/57/EC by the NSA of the Member State having not yet transposed Directive (EU) 2016/797 by 16 June 2019.
As with OGLs, EU GEAs are legal documents. In order to legally use the authorisations, exporters need to ensure that they meet all the licensing terms and conditions including registering before use with the ECJU.
ETIAS will be a largely automated IT system created to identify security, irregular migration or high epidemic risks posed by visa-exempt visitors travelling to the Schengen States, whilst at the same time facilitate crossing borders for the vast majority of travellers who do not pose such risks. Non-EU nationals who do not need a visa to travel to the Schengen area will have to apply for a travel authorisation through the ETIAS system prior to their trip. The information gathered via ETIAS will allow, in full respect of fundamental rights and data protection principles, for advance verification of potential security, irregular migration of high epidemic risks.
After filling in an online application form, the system will conduct checks against EU information systems for borders and security and, in the vast majority of cases, issue a travel authorisation within minutes. In limited cases, where further checks on the traveller are needed, the issuing of the travel authorisation could take up to 30 days. The ETIAS travel authorisation will be a mandatory pre-condition for entry to the Schengen States. It will be checked together with the travel documents by the border guards when crossing the EU border. This prior verification of visa exempt non-EU citizens will facilitate border checks; avoid bureaucracy and delays for travellers when presenting themselves at the borders; ensure a coordinated and harmonised risk assessment of third-country nationals; and substantially reduce the number of refusals of entry at border crossing points.
Thanks to ETIAS authorities will receive vital information necessary to assess potential risks with individuals travelling to the EU and, if required, a travel authorisation could be denied. Schengen participating States will be able to manage their external borders more effectively and improve internal security. Travellers will have early indication of their admissibility to the Schengen States, making legal travel across Schengen borders easier.
The European Travel Information and Authorisation System (ETIAS) is a system for granting authorisation to travel to those countries of the European Union which belong to the Schengen Area. The final decision on crossing the external border lies with the EU Member State of first destination. ETIAS will carry out pre-travel screening of travellers who enjoy from visa-free access to the Schengen Area, and thus allow Member States to deny authorisation to travellers considered to pose a security threat, a risk in terms of irregular migration or public health. In order to cross an external Schengen border, visa-free travellers will need to have both a valid travel document and an ETI