The National Legal Framework (FR)
Transcription
The National Legal Framework (FR)
European Railway Agency Cross Acceptance Unit REFERENCE DOCUMENT PART 3: FRANCE NATIONAL LEGAL FRAMEWORK APPLIED IN CONJUNCTION WITH THE AUTHORISATION OF RAILWAY VEHICLES IN ACCORDANCE TO ART.27 OF DIRECTIVE 20081571EC IN FRANCE DOCUMENT TYPE: TECHNICAL DOCUMENT VERSION: 1.6.1 Edited by Approved by Name Ny Tiana TOURNIER Position Cross Acceptance Unit. Head of Authorisation Processes Sector Benolt Chevalier Sous-directeur de Ia sécurité et de Ia regulation ferroviaires. Ministère de développement durable et l’écologie, du Date & signature. 04 2015 / Background information The 3 sheets: Back Info-General, Back Info - Roles and Resps, and Back Info - Timeframe shall be filled in with the relevant information. The cells coloured in: are those to be filled in. Additional information Additional information to the flowcharts is requested where the objects are bordered with a thick black line. Reference N° of these objects have been introduced. The 8 sheets: Stage 1, Stage 2, Stage 3, Stage 4, Stage 6, Stage 7 and Stage 8 shall be filled in with the relevant information. The cells coloured in: are those to be filled in. Colour coding from the flowcharts legal option non mandatory/commom practice legal option on national level FR NLF 1.6.1 Page 1 of 11 Contact details for National Legal Framework Reporting country Organisation Name France EPSF (*) Contact name E-mail canisius.gassa@securite-ferroviaire.fr Phone number +33 (0)3 22 33 96 22 jerome.fedelich@securite-ferroviaire.fr +33 (0)3 22 33 96 24 GASSA, Canisius FÉDÉLICH, Jérome Office phone number Is there (Yes/No) EN* = not official translations, version of the document is not consolidated (1) = not really simultaneous but cross acceptance agreements exist see art 54 et 56 of décret 2006-1279 (*) EPSF = Établissement Public de Sécurité Ferroviaire (**) RFN = Réseau Ferré National Classification: (general, specific, detailed) Detailed reference of the rule(s) Language(s) that the rule(s) are available in MSs 1. Loi n°2009-1503 relative à l'organisation et à la régulation des transports ferroviaires et portant diverses dispositions relatives aux transports. Interoperability Directive transposed ? (including 2011/18) Yes N/A 2. Décret n°2010-814 du 13 Juillet 2010 relatif à la sécurité et l'interopérabilité du système ferroviaire. 1.FR 3. Arrêté du 27 octobre 2010 relatif à l'immatriculation des véhicules ferroviaires. 2.FR 4. Décret n°2006-1279 du 19 octobre 2006 relatif à la sécurité des circulations ferroviaires et à l'interopérabilité du système ferroviaire. Consolidated version of 14 February 2014. 5. Arrêté du 19 mars 2012 fixant les objectifs, les méthodes, les indicateurs de sécurité et la réglementation technique de sécurité et d'interopérabilité applicables sur le réseau ferré national dit "arrêté réglementation". 3.FR 4.FR+EN* 5.FR 6.FR N/A 6. Arrêté du 23 juillet 2012 relatif aux autorisations de réalisation et de mise en explotation commerciale de véhicules ou autres sous-systèmes de transport ferroviaire nouveaux ou substantiellement modifiés dit "arrêté AMEC". National guideline Yes N/A Guide d'application à l'usage des promoteurs : "Conditions d'autorisation de mise en exploitation commerciale d’un projet sur le RFN(**) et sur les lignes définies par le décret 2010-1201 du 12 octobre 2010, c'est-à-dire la partie française de la section internationale entre Perpignan et Figueras." Guide sur les autorisations de mise en exploitation commerciale. Available on EPSF website Additional authorisation required Vehicle type Time validity of a type Definitions: Upgrading Renewal Specific national arrangements for on track tests Coordination with Procedure for simultaneous application other MSs Yes No No Yes Yes Yes N/A Décret n°2006-1279. Consolidated version of 14 February 2014 (art.54) FR + EN* Décret n°2006-1279. Consolidated version of 14 February 2014 (art. 31.10) Décret n°2006-1279. Consolidated version of 14 February 2014 (art. 31.11) Décret n°2006-1279. Consolidated version of 14 February 2014 (art.10) FR + EN* FR + EN* FR + EN* Fees To obtain the National guideline For the acknowledgement of receipt of application For issuing authorisation No (1) Is there (Yes/No) Amount (Euro) Conditions (fixed/hourly rate) Detailed reference of the rule Language(s) that the rule(s) are available in Hourly rate Article L.2221-6 du code des transports + délibération du conseil d'administration de l'EPSF. Available in the annual activity report on EPSF website. FR Hourly rate Article L.2221-6 du code des transports + délibération du conseil d'administration de l'EPSF. Available in the annual activity report on EPSF website. FR No No Yes For refusal of authorisation Yes For the appeal procedure to NSA For the appeal procedure to Appeal Body For the NSA acting as assessment body (DeBo/CSM) For NSA issuing certificates (DeBo/CSM) No No No No FR NLF 1.6.1 N/A General General General FR cadre technique (92 €/h) cadre confirmé (118 €/h) expert (144 €/h) cadre technique (92 €/h) cadre confirmé (118 €/h) expert (144 €/h) Page 2 of 11 The following roles/actors might be involved in the authorisation procedure for the placing in service of vehicles: applicant, RU, IM, keeper, NoBo, DeBo, NSA, MS, Assessment body (CSM) and others (laboratories, etc.). Some actors may have several roles. For example, an applicant can be also a RU or a NoBo can be also a DeBo. The purpose of this table is to clarify the requirements, if any, for each of the above roles. This table is to be filled with the following information: • the reference to the rules that describe each role and the language(s) in which these rules are available; • a list of criteria that enables the actor to undertake a role; and • a list of all actors able to undertake a role Requirement on the actor for the role Detailed reference of the rule(s) Language(s) that the rule(s) are available in: Applicant RU IM NoBo DeBo NSA 1. Décret n°2006-1279. Consolidated version of 14 February 2014 (art.31) 1. Décret n°2006-1279. Consolidated version of 14 2. Décret n°2006-1279. February 2014 (art.31 & 45) Consolidated version of 14 February 2014 (art.33 & 2. Arrêté du 21 dé cembre titre IV-chapitre IV) 2007 relatif à l'agré ment Décret n°2006-1279. Décret n°2006-1279. Décret n°2006-1279. des experts ou organismes L.2221-1 du Consolidated version of 14 Consolidated version of 14 Consolidated version of 14 3. Arrêté du 14 octobre qualifiés pour évaluer la transports February 2014 (titre IV) February 2014 (art.9) February 2014 (art.9) 2005 relatif aux organismes conception et la ré alisation habilités à mettre en oeuvre de systèmes ou sous les procédures de systèmes ferroviaires vérification « CE » des sous- nouveaux ou systèmes et d'évaluation de substantiellement modifiés la conformité ou de l'aptitude à l'emploi des 3. Arrêté AMEC constituants d'interopérabilité ferroviaire FR + EN* List of acceptance criteria No restriction List of actors entitled to act as: No restriction FR + EN* FR + EN* 1 & 2. - FR + EN* 3.FR 1. FR+ EN* 2 & 3.FR Arrêté AMEC (art.5 & 13) N/A N/A N/A MS code des Appeal Body 1. Décret n°2006-1279. Consolidated version of 14 February 2014 (art.45-2) Décret n°2006-1279. Décret 2010/1023 (section Consolidated version of 14 3, art.10 & 11) February 2014 2. CSM Regulation 3. Arrêté AMEC (art.3) 1 & 2.FR FR + EN* FR Arrêté du 21 décembre 2007 relatif à l'agrément des experts ou organismes qualifiés pour évaluer la conception et la réalisation de systèmes ou sous systèmes ferroviaires nouveaux ou substantiellement modifiés Appointed by law Appointed by law OQA (*) (list available at EPSF EPSF website) Assessment Body (CSM) MEDDE (**) EPSF ARAF (***) Administrative court 1. FR+ EN* 2. EU languages 3. FR Arrêté du 21 dé 2007 (art.4) cembre OQA (*) (list available at EPSF website) EN* = not official translations, version of the document is not consolidated (*) OQA = L’organisme qualifié agréé (**) MEDDE = Ministère de l´Écologie, du Développement Durable et de l´Énergie (***) ARAF = Autorité de Régulation des Activités Ferroviaires FR NLF 1.6.1 Page 3 of 11 Is there a National timeframe FOR NEW AUTORISATION CASE AFTER UPGRADING/RENEWAL Request for review of the refusal by the applicant to the NSA Specify timeframe (maximum) 4 months Décret n°2006-1279. Consolidated version of 14 February 2014 (art.44) FR + EN* Loi n°2000-321 du 12 avril 2000 (art.18, 21 & 22) FR 2 months 2 months For all authorisation cases where there Maintain of the refusal by the NSA is a refusal of authorisation according Request for review of the refusal by the applicant to the to Art 21.7 of Directive 2008/57/EC: appeal body – Possible opinion of the Agency if required by the 2 months appeal body NSA decision to be taken as soon as possible and not later 4 months than, according to Art. 23.7 of 2008/57/EC: (a) after submission of the authorisation file For additional authorisation case of TSI (b) after provision of any additional information requested by 4 months the national safety authority, where applicable conform vehicles 1.Décret n°20061279. Consolidated version of 14 February 2014 1. FR + EN* (art.44.III, 44.IV & 54.IV) 2. FR (c) after provision of the results of any tests requested by the 4 months national safety authority, where applicable 2.Arrêté (art.17) NSA decision to be taken as soon as possible and not later than, according to Art. 25.5 of 2008/57/EC : 4 months (a) after submission of the authorisation file 1.Décret n°20061279. Consolidated version of 14 February 2014 1. FR + EN* (art.44.III, 44.IV & 54.IV) 2. FR For additional authorisation case of (b) after provision of any additional information requested by non-TSI conform vehicle 4 months the national safety authority, where applicable (c) after provision of the results of any tests requested by the 4 months national safety authority, where applicable For tests/checks (including network compatibility) with the identified actors, in particular the IM, to take place not later 4 months For all additional authorisation cases: than, according to Art. 23.6 and Art.25.4 of Directive TSI and non-TSI conform vehicles 2008/57/EC when there is a deemed authorisation according to Art.21.8 of 2 months Directive 2008/57/EC EN* = not official translations, version of the document is not consolidated FR NLF 1.6.1 Language(s) Detailed reference that the rule(s) of the rule(s) are available in 2.Arrêté (art.17) AMEC AMEC Décret n°2006-1279. Consolidated version of 14 February 2014 (art.44.III & 54.IV) FR + EN* FR + EN* Page 4 of 11 Reference No in flowcharts 1.I Reference to object in flowchart Submit the file describing the project to the MS Requirement that needs additional information The detailed reference of the rule(s) that specify the requirements 1. Décret n°2006-1279. Consolidated version of 14 February 2014 (art.54; vehicle already authorised in another MS) Requirements for the content of the file describing 2. Décret n°2006-1279. Consolidated 1. & 2. FR+ EN* the project version of 14 February 2014 (art.55; vehicle already authorised in France and subject to a substantial modification). 1. Décret n°2006-1279. Consolidated Requirements for the content of the file of the version of 14 February 2014 (art.54) previous authorisation(s) 2. Arrêté AMEC (annexe V) 1.II Language(s) that the rule(s) are available in 1.FR + EN* 2.FR Examine: file of the previous authorisation(s) records on maintenance, operation and technical modifications 1. Décret n°2006-1279. Consolidated Requirements for the content of the records on version of 14 February 2014 (art.54) maintenance, operation and modifications 2. Arrêté AMEC (annexe V) 1.III Submit the file describing the project to the MS Requirements for the content of the file describing the project 1.IV Is a new authorisation required for the project? The criteria for a new authorisation 1.FR + EN* 2.FR No Décret n°2006-1279. Consolidated version of 14 February 2014 (art.44.I) FR + EN* EN* = not official translations, version of the document is not consolidated FR NLF 1.6.1 Page 5 of 11 Reference no in flowcharts Reference to object in flowchart Requirement that needs additional information The detailed reference of the rule(s) that specify the requirements Décret 2.I n°2006-1279. Language(s) that the rule(s) are available in Consolidated Request for track access to run on track test, when Procedure for establishing the conditions to run on version of 14 February 2014 (art.10) necessary track tests FR + EN* SMS(*) of the IM EN* = not official translations, version of the document is not consolidated (*) SMS = Safety Management System FR NLF 1.6.1 Page 6 of 11 Reference no in flowcharts Reference to object in flowchart Requirement that needs additional information The detailed reference of the rule(s) that specify the requirements Language(s) that the rule(s) are available in 3.I Perform verification (including tests and on track tests where necessary) against applicable TSIs and NRs, and The requirements for evidences establish evidences 1. Décret n°2006-1279. Consolidated version of 14 February 2014 (art.46, 51 1.FR + EN* & 52) 2.FR 2. Arrêté AMEC 3.II Perform verification of conformity to type, and The requirements for evidences establish evidences 1. Décret n°2006-1279. Consolidated 1.FR + EN* version of 14 February 2014 (art.53) 2.FR 2. Arrêté AMEC (art.12) 3.III Supply evidences on the completion of the relevant The requirements for evidences assessment of conformity to type 1. Décret n°2006-1279. Consolidated 1.FR + EN* version of 14 February 2014 (art.53) 2.FR 2. Arrêté AMEC 3.IV Supply evidences on the completion of the relevant The requirements for evidences assessment of conformity to type 1. Décret n°2006-1279. Consolidated 1.FR + EN* version of 14 February 2014 (art.53) 2.FR 2. Arrêté AMEC 3.V Apply CSM Regulation for safe integration The requirements for risk assessment 1. CSM directly applicable 2. Arrêté AMEC 3.VI Provide certificate(s) from assessment applicable TSIs requirements to applicant The requirements for evidences 1. Décret n°2006-1279. Consolidated version of 14 February 2014 (art.46, 51 1.FR + EN* & 52) 2.FR 2. Arrêté AMEC (annexes VI & VII) The requirements for evidences 1. Décret n°2006-1279. Consolidated version of 14 February 2014 (art.46, 51 1.FR + EN* & 52) 2.FR 2. Arrêté AMEC (art.15) 3.VII Provide certificate(s) from assessment applicable NRs requirements to applicant against against The requirements for the content of the safety assessment report EN* = not official translations, version of the document is not consolidated 3.VIII FR NLF 1.6.1 Provide safety assessment report to applicant 1.EU languages 2.FR + EN* Regulation (UE) N°402/2013 (art.6 & 15) EU languages Page 7 of 11 Reference no in flowcharts 4.I Reference to object in flowchart Decision on the remedial action? Requirement that needs additional information Possible remedial actions: Alternative method, 1. Règlement CSM Design modification, Change of the conditions of 2. Arrêté réglementation (art.4) use/restrictions The criteria for decision on the remedial action. FR NLF 1.6.1 The detailed reference of the rule(s) that specify the requirements Arrêté réglementation (art.4.III) Language(s) that the rule(s) are available in 1.EU languages 2.FR FR Page 8 of 11 Reference no in flowcharts 6.I 6.II 6.III Reference to object in flowchart Requirement that needs additional information The detailed reference of the rule(s) that specify the requirements Requirements for the content of the authorisation file (including the “technical files”) : - If there is a clear check list to be adhered to when compiling the authorisation file 1. Décret n°2006-1279. Consolidated version of 14 February 2014 (art.53 & - Make a copy of the initial technical file (previous 54) authorisation(s)) 2. Arrêté AMEC (annex IV) - Collect records on operation and technical 1. Décret n°2006-1279. Consolidated - The accepted documentation for authorisation granted modifications version of 14 February 2014 (art.54) before the implementation of Directive 2008/57/EC. 2. Arrêté AMEC (annex IV) Requirements for the content of the authorisation file 1. Décret n°2006-1279. Consolidated (including the “technical files”) : version of 14 February 2014 (art.54) - If there is a clear check list to be adhered to when 2. Arrêté AMEC (annex IV) Identify the content of the technical file for the compiling the authorisation file DeBo(s) part 1. Décret n°2006-1279. Consolidated - The accepted documentation for authorisation granted version of 14 February 2014 (art.54) before the implementation of Directive 2008/57/EC. 2. Arrêté AMEC (annex IV) Requirements for the content of the authorisation file (including the “technical files”) : Arrêté AMEC (annex IV) - If there is a clear check list to be adhered to when Identify the content of the technical file for the compiling the authorisation file Assessment body (CSM) part 6.IV Compile the authorisation file 6.V Identify the format and documentation application for authorisation: -Vehicle type and/or - Vehicle placing in servcie 6.VI Submit the official Application for authorisation Language(s) that the rule(s) are available in 1. FR+EN* 2. FR 1. FR+ EN* 2. FR 1. FR+EN* 2. FR 1. FR+EN* 2. FR FR 1.Décret n°2006-1279. Consolidated - The accepted documentation for authorisation granted version of 14 February 2014 (art. 44 II) before the implementation of Directive 2008/57/EC. 2. Arrêté AMEC (art.2, 5 & 13) 1. FR+EN* 2. FR The requirements and the content for the official Décret n°2006-1279. Consolidated application version of 14 February 2014 (art.51) FR+EN* of the The requirements and the content for the official application Arrêté AMEC Time frame for the submission of the official application from the pre-engagement baseline, if any No FR EN* = not official translations, version of the document is not consolidated FR NLF 1.6.1 Page 9 of 11 Reference no in flowcharts Reference to object in flowchart 7.I Acknowledge receipt of application 7.II Declare the vehicle deemed authorised 7.III 7.IV Is there an appeal to NSA? Issuing the authorisation Requirement that needs additional information The requirements for the acknowledgement of the Arrêté AMEC (art.17) receipt of application Décret 2006-1279. Consolidated The requirements for deemed authorisation version of 14 February 2014 (art.54.IV) 1. Loi n° 2000-321 du 12 avril 2000 relative aux droits des citoyens dans leurs relations avec les The requirements for appeal to NSA administrations. 2. Arrêté AMEC (art.13, courrier d'accusé de reception). FR NLF 1.6.1 Identify conditions for archiving the authorisation file Language(s) that the rule(s) are available in FR FR+EN* FR Loi n° 2000-321 du 12 avril 2000 The requirements for the content of justification of relative aux droits des citoyens dans appeal to NSA leurs relations avec les administrations. FR The requirements for launching appeal to the Article L.2134-1 appeal body transports FR The requirements for issuing authorisation The requirements authorisation file EN* = not official translations, version of the document is not consolidated 7.V The detailed reference of the rule(s) that specify the requirements for NSA archiving the du code des 1.Décret 2006-1279. Consolidated version of 14 February 2014 (titre V) 2.Guide AMEC 1.FR+EN* 2.FR EPSF Internal archiving procedure FR Page 10 of 11 Reference no in flowcharts Reference to object in flowchart Requirement that needs additional information The detailed reference of the rule(s) that specify the requirements 8.I Forms for: - authorisation for placing in service of vehicle(s) and - authorisation for type of vehicle 1.Décret n°2006-1279. Consolidated version of 14 February 2014 (art.44 & The format of issued authorisation (of vehicle type 53). 2. Arrêté AMEC (art.12). and of placing in service of vehicle) 3.Procédure interne de la Direction Autorisation EPSF 8.II Form for authorisation for type of vehicle The format of issued authorisation of vehicle type No 8.III Inform ERA on deemed vehicle type authorisation The procedure for informing the Agency on deemed vehicle type authorisation No FR NLF 1.6.1 Language(s) that the rule(s) are available in FR Page 11 of 11 Annex A: Master diagram Process for Authorisation for placing in service of vehicles and/or type of vehicles Start S1. Identify the rules, applicable requirements, conditions of use and assessments Where it is not necessary to update the verification procedures for renewed authorisation In case of subsequent authorisation S2. Pre-engagement In case of: Modification of vehicle design Authorisation with conditions of use and/or restrictions is not possible In case of refusal of alternative method Alternative method S3. Assessment Version 1.6.1 FR S4.Corrections of non- conformities In case of: Correction of non-conformities is not necessary Verfication and assessment results are ok In case of New (Upgrade/renewal) authorisation is not required. S5.Establishing certificates and declarations of verification In case of extension of type validity when renewed authorisation is not required. S6. Compiling the authorisation file and submitting the application S7. Processing the application for authorisation S8. Final documentation and authorisation End Where: Application is not complete Information is missing There is no appeal to NSA or Appeal Body There is a negative appeal decision There is a refusal of authorisation without appeal to NSA Annex B End of stage 4 Where: there is a modification of vehicle design, or authorisation with conditions of use and/or restrictions is not possible End of stage 7 where: the application is not complete, or there is a negative appeal decision, or there is a refusal of authorisation without appeal Start Legal option Non mandatory / Common practice FR Legal option R: Recommendation 2011/217/EU ID: Interoperability Directive 2008/57/EC CSM: CSM Regulation 352/2009 * The timeline starts from the moment the complete file has been submitted by the applicant Décret n°2006-1279 du 19 octobre 2006. Consolidated version of 14 February 2014 Arrêté AMEC (23 juillet 2012) Stage 1 – Identify the rules, applicable requirements, conditions of use and assessments Applicant MS Start Substage 1-1 Decision on authorisation case Identify: TSI (including derogations if any) and NR requirements, Conditions of use ID:22,24 Verification procedures (including alternative methods, if any), and Required assessment bodies ID:5.1;5.2;5.3; End Substage 1-1 First Evaluation of impact in safety and interoperability, identifying: TSIs (including derogations if any) and NRs requirements related to the changes and their impact Conditions of use, and Verification procedures (including alternative methods, if any) New (Upgrade /renewal) ID:20 I Submit the file describing the project to the MS ID:20.1 File describing the project ID:20.1 Décret 2006-1279 (art.42.II.3, 44.I & 55) Arrêté AMEC (art.3, 10 & 18) 5.6;5.8;9;22.2; R:1;3.1.3; Subsequent Additional ID:26.3 R:5.5 ID:21.5, 23,25, Identify: the authorised vehicle type, and required assessment bodies II Renewed Examine: file of the previous authorisation(s) records on maintenance, operation and technical modifications ID:23.3, 25.2 Version 1.6.1 FR Result from examination of the: file of the previous authorisation(s) records on maintenance, operation and technical modifications ID:26.3 R:5.5 ID:26.3. Identify : changed TSI (including derogations if any) requirements, NRs and/or verification procedures (including alternative methods, if any) correction of critical errors, issued type authorisation ID:26.3. TSI conform vehicle? Yes No ID:23.4-6 Identify : the applicable category B and C national rules that are related to: technical compatibility including open points in the TSIs specific cases in the TSIs derogations if any the associated verification Procedures (including alternative methods, if any); conditions of use and the required assessment bodies Examine the file describing the project ID:20.1 III Submit the file describing the project to the MS File describing the project Notification of a need to renew type authorisation Update of verification procedures? Identify: the applicable category B and C national rules that are related to technical compatibility the associated verification procedures (including alternative methods, if any) conditions of use and the required assessment bodies ID:25.3-4 Result from examination of the file describing the project ID:20.1 Is renewed authorisation required? ID:26.3. Yes Notification of “extension” of type validity No IV Is a new authorisation required for the project? Yes ID:20.1 Yes Update of verification procedure(s) No Beginning of stage 3 Beginning of stage 2 No Identify: TSIs (including derogations if any) and NRs requirements related to the changes and their impact Conditions of use, and Verification procedures (including alternative methods, if any) ID:20 List of requirements (TSI and technical characteristics applicable in place of TSI) Identify required assessment bodies OR Update verification procedure(s) ID:20.2 Beginning of stage 3 ID:20 Beginning of stage 3 Beginning of Stage 8 END Start Substage 1-1 Non mandatory/ Common practice Stage 1 - Identify the rules, applicable requirements, conditions of use and assessments – Substage 1: Decide on authorisation case Applicant Version 1.6.1 FR Identify: -Project scope -TSIs and NRs,in particular A classified rules, related to the change -Conditions of use, and -Verification procedures (including alternative methods, if any) Consult the applicable TSIs, NRD(s) of the MS(s) where authorisation is applied for Plan Is authorisation of type still valid? No No Is it Intended to be authorised in other MS(s) than First MS? No Is it a New/Changed basic design of vehicle/ type of vehicle? Is it a New basic design? Yes Yes Yes No Yes Decision on authorisation case: Renewed Decision on authorisation case: Subsequent Decision on authorisation case: Additional Decision on authorisation case: First End Substage 1-1 Decision on authorisation case: New (Upgrade/ Renewal) Annex B Legal option End of stage 1 Non mandatory / Common practice End of stage 4 for alternative method FR Legal option R: Recommendation 2011/217/EU ID: Interoperability Directive 2008/57/EC CSM: CSM Regulation 352/2009 Annex C Décret n°2006-1279 du 19 octobre 2006. Consolidated version of 14 February 2014 Arrêté AMEC (23 juillet 2012) Stage 2 – Pre-engagement Applicant Select assessment bodies Compile applicable TSI rules and/or NRs and technical solutions (acceptable means of compliance) and the associated verification procedures including additional information to be supplied, risk analyses to be carried out in accordance with Article 6(3)(a) of Directive 2004/49/EC or tests to be conducted on the network in order to verify the criteria referred to in paragraph 4 of Art 23 of 2008/57/EC NSA Start Substage 2-1 DeBo Proposal for pre -engagement NoBo Assessment body (CSM) IM Proposal for pre -engagement End Substage 2-1 Is there a proposal for an alternative method? Start Substage 2-2 Yes Refusal Evaluate proposal for alternative method to meet essential requirements Evaluate proposal for alternative method to meet essential requirements End Substage 2-2 Acceptance No ID:23.6, 25.4 I Request for track access Request for track access to run on track test, when necessary ID:23.6, 25.4 ID:23.6, 25.4 Track access to run on track tests Agreement to track access Will the test take place within the legal timeframe? Yes No Ask NSA to ensure that the tests take place within the legal timeframe ID:23.6, 25.4 ID:23.6, 25.4 Take measures to ensure that the tests take place within the legal timeframe NSA measures for IM to respect the legal timeframe ID:23.6, 25.4 ID:23.6, 25.4 Reviewed acces provisions to run on track tests Review the access provisions to run on track tests OR Is this a First authorisation? Submit pre- engagement file, including proposal for alternative methods, if any to: NSA, assessment bodies Mandatory in case of Yes first authorisation. Arrêté AMEC (art.3 & 6) Pre-engagement file Décret 2006-1279 (art.44.II, 44.IV & 46) Arrêté AMEC (art.3 & 6) Pre-engagement file Pre-engagement file Décret 2006-1279 (art.44.II, 44.IV & 46) Arrêté AMEC (art.3 & 6) Version 1.6.1 FR Décret 2006-1279 (art.44.II, 44.IV & 46) Arrêté AMEC (art.3 & 6) Examine and agree on the preengagement file AND Examine and agree on the preengagement file Examine and agree on the preengagement file Décret 2006-1279 (art.44.II, 44.IV & 46) Arrêté AMEC (art.3 & 6) Compile and Present preengagement file to NSA Décret 2006-1279 (art.44.II, 44.IV & 46) Arrêté AMEC (art.6) Pre engagement baseline draft No Arrêté AMEC (art.6) Discussion and examination on pre engagement baseline draft Arrêté AMEC (art.6) Update of the draft pre-engagement baseline Examination of NSA opinion Arrêté AMEC (art.6) NSA opinion Arrêté AMEC (art.6) Arrêté AMEC (art.6) Pre-engagement baseline Submit pre- engagement file, including proposal for alternative methods, if any to: NSA, assessment bodies Pre-engagement file Pre-engagement file Pre-engagement file Examine and agree on the preengagement file Examine and agree on the preengagement file Examine and agree on the preengagement file Pre-engagement baseline AND Present preengagement file to NSA Pre engagement baseline draft Discussion and examination on pre engagement baseline draft Update of the draft pre-engagement baseline Pre-engagement baseline Beginning of stage 4 for refusal of alternative method Beginning of stage 3 ID:23.6, 25.4 Examination of NSA opinion NSA opinion Pre-engagement baseline Non mandatory/ Common practice Annex C Stage 2 – Pre-engagement – Substage 1: Proposal for pre-engagement Applicant NoBo DeBo Assessment body (CSM) Draft preengagement file Draft preengagement file Draft preengagement file Review of the draft for the preengagement file Review of the draft for the preengagement file Review of the draft for the preengagement file Submit draft preengagement file to assessment bodies Version 1.6.1 FR Start Substage 2-1 AND End Substage 2-1 Non mandatory/ Common practice Annex C Stage 2 – Pre-engagement – Substage 2: Evaluate proposal for alternative method to meet essential requirements Applicant Start Substage 2-2 NSA DeBo Assessment body (CSM) Alternative method of meeting the essential requirements Propose alternative method of meeting the essential requirements Perform the Safety Assessment Provide Safety Assessment report Safety Assessment Report Version 1.6.1 FR Submit alternative methods with supporting evidence (Safety Assessment Report) Alternative methods with supporting evidence Can alternative method be accepted? No Yes Refusal of alternative method Acceptance of alternative method Decision to refuse alternative method Decision to accept alternative method Supply assessment bodies with the accepted alternative method Accepted alternative method End substage 2-2 End of stage 2 for first and renewed (with update of verification procedures) authorisation cases End of Stage 1 for additional and new authorisation cases End of stage 1 for renewed without update of verification procedures R: Recommendation 2011/217/EU ID: Interoperability Directive 2008/57/EC CSM: CSM Regulation 352/2009 Legal option Non mandatory / Common practice End of Stage 1 only for subsequent authorisation case FR Legal option Annex D Arrêté AMEC (23 juillet 2012) Stage 3 - Assessment Applicant NoBo Assessment body (CSM) DeBo I Perform verification (including tests and on track tests where necessary) against applicable TSIs and NRs, and establish evidences II Perform verification of conformity to type, and establish evidences Evidences on the completion of the relevant verifications of conformity to type ID:26.5 Evidence of conformity to type shall be provided by the manufactuer ID:21 Evidences on the completion of the relevant verifications (including tests and on track tests where necessary) against applicable TSIs and NRs Is a specific request to assessment body(es) needed according to the chosen verification procedures? Yes Request to assessment bodies to: - assess conformity to type - provide evidence (e.g. the applicant has/has not Quality Management System that covers all parts of the vehicle) Assess conformity to type according to NR(s) Assess conformity to type according to TSI(s) ID:26.5 ID:26.5(b) ID:26.5(a) ID:21 III Request to assessment bodies to: - perform assessment against applicable TSIs and NRs and - provide certificates/ reports ID:26.5(a) IV ID:26.5(b) Supply evidences on the completion of the relevant assessment of conformity to type Supply evidences on the completion of the relevant assessment of conformity to type No ID:21 AND/OR Are all the requirements for technical compatibility and safe integration covered by NRs/TSIs? ID:23, 25 OR Is it an additional authorisation? Yes Yes R: 5.3 No No V Apply CSM Regulation for safe integration Perform assessment against applicable TSIs requirements Perform risk assessment ID:15.1 Version 1.6.1 FR Yes ID:18; R:4.2.1 Evidences (e.g. copy of certificates [TSI, National rules] that might cover several vehicles) on the completion of the relevant verifications to type Perform assessment against applicable NRs requirements VII VI Certificate(s) from assessment against applicable TSIs requirements CSM:2.2 R: 5.3 Is documentation for safety assessment necessary? ID:17.3: R:4.2.2 CSM:7.3 ID:18; R:4.2.1 CSM:7.3 ID:15.1 CSM:2.2 R: 5.3 Provide certificate(s) from assessment against applicable TSIs requirements to applicant ID:18; R:4.2.1 CSM:7.3 Provide certificate(s) from assessment against applicable NRs requirements to applicant ID:17.3: R:4.2.2 CSM:7.3 Certificate(s) from assessment against applicable NRs requirements Risk assessment report from the applicant ID:17.3; R:4.2,2 CSM:6.1 ID:26.4-5 Is documentation for safety assessment necessary? No No Yes CSM: Annex I.5 Provide documentation for safety assessment to Assessment body (CSM) Collect documentation Provide documentation for safety assessment to Assessment body (CSM) CSM: 6.1, 7.1 CSM: Annex I.5 Perform safety assessment CSM: 6.1, 7.1 VIII CSM:7 Safety assessment report Provide safety assessment report to applicant CSM:7.1 AND/OR Send the file to the CSM assessor for coherence check of the file Arrêté AMEC (art.13) Yes ID: 22.2(b), 24.2, 23.3, Are the 25.2, 26.5 verification and assessment results ok? Safety assessment report Arrêté AMEC (art.13) Check coherence of the file Arrêté AMEC (art.13) No Beginning of stage 5 Beginning of stage 4 Non mandatory/ Common practice End of stage 3 Stage 2 for refusal of alternative method FR Legal option Arrêté réglementation (19 mars 2012) Annex E Stage 4 - Correction of non-conformities Applicant I Decision on the remedial action? Change the conditions for use/restrictions DeBo Evaluate (technically and/ or economically) possible conditions of use and/or other restrictions Version 1.6.1 FR Arrêté réglementation (art.4) Is authorisation with conditions of use and/or restrictions possible based on the results from the evaluation? Design modification Alternative method Modify vehicle design including software modification Yes No Prepare conditions of use and/or other restrictions Modification of vehicle design Conditions of use and/or other restrictions Beginning of stage 2 Beginning of stage 1 Beginning of stage 5 Legal option End of stage 3 when verification and assessment results are ok for subsequent authorisation End of stage 3, for all other cases, when verification and assessment results are ok R: Recommendation 2011/217/EU ID: Interoperability Directive 2008/57/EC CSM: CSM Regulation 352/2009 Annex F End of stage 4 Stage 5 - Establishing certificates and declarations of verification Applicant NoBo DeBo Assessment body (CSM) OR ID:26.5 Establish the declaration of conformity to the authorised type ID: 23,25 Is it the case of additional authorisation? Yes Version 1.6.1 FR No ID: Annex VI R:8.;8.5; Declaration of conformity to type Elaborate and compile EC certificate documentation Elaborate and compile NR certificate documentation ID: Annex VI R:8.6 Provide EC certificates ID:26.5 Reg:201/2011 ID: Annex VI R:8.;8.9; EC Certificate(s) NR Certifcate(s) ID: Annex VI R:8.;8.5; ID: Annex VI R:3.2; CSM report(s) ID: Annex VI R:5.3.1;5.3.2 Is it a vehicle type authorisation only? ID: 26 Yes Beginning of Stage 6 No Establish EC and/or NR declarations of verification ID: Annex V .1,2 EC and/or NR declarations of verification ID:Annex VI-2.3.1;3 R:4.2.3 Provide NR certificates ID: Annex VI R:8.6 Elaborate and compile CSM report documentation ID: Annex VI R:8.9; CSM:7 Provide CSM report ID: Annex VI R:8.9; CSM:7 Legal option End of stage 5 R: Recommendation 2011/217/EU ID: Interoperability Directive 2008/57/EC Annex G Stage 6 - Compiling the authorisation file and submitting the application Applicant Is it the case of additional authorisation? NSA Yes ID:23,25 No I III II - Make a copy of the initial technical file ( previous authorisation(s)) - Collect records on maintenance, operation and technical modifications Identify the content of the technical file for the DeBo(s) part R:8.6;4.2.2; ID Annex VI- 3.3 ID:23.3, 25.2 Version 1.6.1 FR File of the previous authorisation(s) Records on maintenance, operation and technical modifications Identify the content of the technical file for the Assessment body (CSM) part Technical file related to NRs Assessment body (CSM) report on CSM R:8.6;4.2.2; ID Annex VI- 3.3 ID:23.3, 25.2 R:5.3.2; ID:Annex VI- 2.4 R:5.3.2; ID:Annex VI- 2.4 AND/OR IV Compile the authorisation file ID: 23.3, 25.2 ID: 23.3, 25.2 Authorisation file ID: Annex VI-2.6 Archived authorisation file Archive authorisation file V ID:21.6;23.7;25.5 Annex VI:2.6 R:8.1; Identify the format and documentation of the application for authorisation: Vehicle type and/or Vehicle placing in servcie VI ID: Annex VI-2.6 ID:21.6;23.7;25.5 Annex VI:2.6 R:8.1; Submit the official Application for authorisation ID:21.6;23.7;25.5 Annex VI:2.6 R:8.1; Application for authorisation Beginning of stage 7 Legal option (*)The timeline starts from the moment the application has been acknowledged Non mandatory/ Common practice End of stage 6 FR Legal option R: Recommendation 2011/217/EU ID: Interoperability Directive 2008/57/EC Annex H Arrêté AMEC (23 juillet 2012) Stage 7 - Processing the application for authorisation Applicant NSA Letter or any other means of acknowldegement the receipt of application Appeal body Acknowledge receipt AND Complete the information Complementary information OR Yes Check the completeness of application In this context “information” = documents Letter stating: the incomplete application the missing information Is it only a need for additional documentation? Identify missing information Is the application complete? R:4.2.3; No (*)Letter or any other means of acknowledgement of receipt of application ID:20.1; Acknowledgement 23.7.a;25.5.a Acknowledge completeness of application of completeness (instead of receipt) of application Is it the case of additional authorisation? ID:23,25 Yes Is there a NSA decision within the EU legal timeframe? ID: 21.8 II Yes I No Yes No Refusal of authorisation Declare the vehicle deemed authorised ID: 21.7 Justify refusal of authorisation ID: 21.7 Is authorisation granted? ID: 22.2, R:8.7 No ID: 21.8 III ID: 21.7 Is there an appeal to NSA? Version 1.6.1 FR Yes Yes ID: 21.7 Decision to make an appeal to NSA ID: 21.7 Decision to make an appeal to NSA Start Substage 7-1 No Appeal End Substage 7-1 No Negative appeal decision There is no appeal To appeal body The NSA decision is changed after: appeal to NSA or appeal to appeal body Positive appeal decision OR IV Issuing the authorisation ID: 15.1 R:2.1;5.1.1; V Identify conditions for archiving the authorisation file Conditions for archiving the authorisation file Beginning of stage 1 Arrêté AMEC (art.17) Beginning of stage 8 ERA Start Substage 7-1 (*) Timeline starts from the moment the NSA has refused the autorisation (**) Timeline starts from the receipt of the appeal from the applicant (***) Timeline starts from the request of the appeal body to ERA for an opinion Legal option ID: Interoperability Directive 2008/57/EC Non mandatory/ Common practice Annex H Stage 7 - Processing the application for authorisation – Substage 1: Appeal Applicant NSA Justify appeal to NSA Make an appeal to appeal body? ID: 21.7 (**) Refusal of authorisation ID: 21.7 ID: 21.7 (*)Appeal to NSA ID: 21.7 Maintain refusal of No authorisation ID: 21.7 Appeal body ERA Review NSA decision ID: 21.7 Request for appeal Change NSA decision? ID: 21.7 ID: 21.7 No Yes ERA opinion required? Review NSA decision ID: 21.7 Yes ID: 21.7 Accept the appeal? ID: 21.10 ID: 21.7 Version 1.6.1 FR Request for ERA opinion Make request to ERA Launch appeal procedure ID: 21.10 ID: 21.10 Negative appeal decision Inform applicant on negative appeal decisionID: 21.7 ID: 21.7 Negative appeal decision Yes No No (***) Notification of ERA opinion ID: 21.10 (***) Notification of ERA opinion ID: 21.10 Establish ERA opinion ID: 21.10 (***) Notification of ERA opinion ID: 21.10 Positive appeal decision ID: 21.7 (**)Positive appeal decision ID: 21.7 End Substage 7-1 Reverse refusal of authorisation ID: 21.7 Yes Legal option Annex I ID: Interoperability Directive 2008/57/EC Non mandatory / Common practice Décret n°2006-1279 du 19 octobre 2006. Consolidated End of stage 7 Deemed Authorisation FR Legal option End of stage 7 Issued Authorisation version of 14 February 2014 Arrêté du 23 juillet 2012 dit "arrêté AMEC" End of stage 1 for extension of type validity Stage 8- Final documentation and authorisation Applicant NSA Establish the forms for: authorisation for placing in service of vehicle(s)) and authorisation for type of vehicle No ERA Is it a vehicle type authorisation only? Yes Establish the form for authorisation for type of vehicle ID:26,1-2 I Forms for: authorisation for placing in service of vehicle(s) and authorisation for type of vehicle Décret n°2006-1279 (art.44 & 53) Arrêté AMEC (art.12) II Version 1.6.1 FR Form for authorisation for type of vehicle Inform ERA on issued authorisation for type of vehicle ID:26,7. OR III Information on vehicle type authorisation ID:26,7. Inform ERA on deemed vehicle type authorisation ID:26,7. Document on deemed vehicle type authorisation Confirmation of deemed vehicle type authorisation Inform the concerned NSA of the deemed vehicle type authorisation Register in ERATV ID:34. Registration in ERATV ID:34. END