CELEX: 32012R0290
Language: en
Date: 2012-03-30 00:00:00
Title: Commission Regulation (EU) No 290/2012 of 30 March 2012 amending Regulation (EU) No 1178/2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council

5.4.2012   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 100/1
            
         COMMISSION REGULATION (EU) No 290/2012
   of 30 March 2012
   amending Regulation (EU) No 1178/2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (1), and in particular Articles 7(6), 8(5) and 10(5) thereof,
   Whereas:
   
               (1)
            
            
               Commission Regulation (EU) No 1178/2011 (2) lays down detailed rules for certain pilots’ licences and for the conversion of national pilots’ licences and of national flight engineers’ licences into pilots’ licences, as well as the conditions for the acceptance of licences from third countries. Rules for pilots’ medical certificates, the conditions for the conversion of national medical certificates and the certification of aero-medical examiners are also set out in that Regulation. In addition, Regulation (EU) No 1178/2011 includes provisions on medical fitness of the cabin crew.
            
         
               (2)
            
            
               According to Regulation (EC) No 216/2008, pilot training organisations and aero-medical centres are to hold a certificate. The certificate is to be issued upon fulfilment of certain technical and administrative requirements. Rules on the administration and management system of these organisations should therefore be provided for.
            
         
               (3)
            
            
               Flight simulation training devices used for pilot training, testing and checking are to be certified against a set of technical criteria. Those technical requirements and administrative procedures should therefore be provided for.
            
         
               (4)
            
            
               According to Regulation (EC) No 216/2008, cabin crew are to be continuously fit and competent to exercise their assigned safety duties. Those involved in commercial operations are to hold an attestation as initially set out in Annex III, Subpart O, point (d) of OPS 1.1005 to Council Regulation (EEC) No 3922/91 of 16 December 1991 on the harmonisation of technical requirements and administrative procedures in the field of civil aviation (3). Rules on cabin crew qualifications and related attestations should therefore be provided for.
            
         
               (5)
            
            
               Oversight capabilities of competent authorities are not provided for in Regulation (EU) No 1178/2011. This Regulation therefore amends Regulation (EU) No 1178/2011 to include administration and management system of competent authorities and organisations. In accordance with Regulation (EC) No 216/2008, rules on an information network between the Member States, the Commission and the Agency should also be included in Regulation (EU) No 1178/2011.
            
         
               (6)
            
            
               It is necessary to provide sufficient time for the aeronautical industry and Member State administrations to adapt to the new regulatory framework and to recognise under certain conditions the validity of certificates, including attestations of safety training, issued before this Regulation applies.
            
         
               (7)
            
            
               In order to ensure a smooth transition and a high uniform level of civil aviation safety in the Union, implementing measures should reflect the state of the art, including best practices, and scientific and technical progress in the field of aircrew training. Accordingly, Regulation (EEC) No 3922/91 as well as technical requirements and administrative procedures agreed by the International Civil Aviation Organisation (‘ICAO’) and the Joint Aviation Authorities until 30 June 2009, and existing legislation pertaining to a specific national environment, should be considered.
            
         
               (8)
            
            
               Regulation (EU) No 1178/2011 should therefore be amended accordingly.
            
         
               (9)
            
            
               The measures specified in Annex III to Regulation (EEC) No 3922/91 for the attestation of safety training of cabin crew are deleted in accordance with Article 69(3) of Regulation (EC) No 216/2008. The measures adopted by this Regulation are to be regarded as the corresponding measures.
            
         
               (10)
            
            
               The European Aviation Safety Agency (‘the Agency’) prepared draft implementing rules and submitted them as an opinion to the Commission in accordance with Article 19(1) of Regulation (EC) No 216/2008.
            
         
               (11)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 65 of Regulation (EC) No 216/2008,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   Regulation (EU) No 1178/2011 is amended as follows:
   
               (1)
            
            
               in Article 1, the following points are added:
               
                           ‘6.
                        
                        
                           the conditions for issuing, maintaining, amending, limiting, suspending or revoking cabin crew attestations, as well as the privileges and responsibilities of the holders of cabin crew attestations;
                        
                     
                           7.
                        
                        
                           the conditions for issuing, maintaining, amending, limiting, suspending or revoking certificates of pilot training organisations and of aero-medical centres involved in the qualification and aero-medical assessment of civil aviation aircrew;
                        
                     
                           8.
                        
                        
                           the requirements for the certification of flight simulation training devices and for organisations operating and using those devices;
                        
                     
                           9.
                        
                        
                           the requirements for the administration and management system to be fulfilled by the Member States, the Agency and the organisations in relation with the rules referred to in points 1 to 8.’;
                        
                     
         
               (2)
            
            
               in Article 2, the following points (11), (12) and (13) are added:
               
                           ‘(11)
                        
                        
                           “Cabin crew member” means an appropriately qualified crew member, other than a flight crew or technical crew member, who is assigned by an operator to perform duties related to the safety of passengers and flight during operations;
                        
                     
                           (12)
                        
                        
                           “Aircrew” means flight crew and cabin crew;
                        
                     
                           (13)
                        
                        
                           “JAR-compliant certificate, approval or organisation” means the certificate or approval issued or recognised or the organisation certified, approved, registered or recognised, in accordance with the national legislation reflecting JAR and procedures, by a Member State having implemented the relevant JAR and having been recommended for mutual recognition within the Joint Aviation Authorities’ system in relation to such JAR.’;
                        
                     
         
               (3)
            
            
               in Article 4(1):
               
                           —
                        
                        
                           the expression ‘8 April 2012’ is replaced by ‘this Regulation applies’;
                        
                     
                           —
                        
                        
                           the expression ‘8 April 2017’ is replaced by ‘8 April 2018’;
                        
                     
         
               (4)
            
            
               the following Articles 10a, 10b and 10c are inserted:
               ‘Article 10a
               Pilot training organisations
               1.   Pilot training organisations shall comply with the technical requirements and administrative procedures laid down in Annexes VI and VII and shall be certified.
               2.   Pilot training organisations holding JAR-compliant certificates issued or recognised by a Member State before this Regulation applies shall be deemed to hold a certificate issued in accordance with this Regulation.
               In such case the privileges of these organisations shall be limited to the privileges included in the approval issued by the Member State.
               Without prejudice to Article 2, pilot training organisations shall adapt their management system, training programmes, procedures and manuals to be compliant with Annex VII by 8 April 2014 at the latest.
               3.   JAR-compliant training organisations registered in a Member State before this Regulation applies shall be allowed to provide training for a JAR-compliant private pilot licence (PPL).
               4.   Member States shall replace the certificates referred to in the first subparagraph of paragraph 2 with certificates complying with the format laid down in Annex VI by 8 April 2017 at the latest.
               Article 10b
               Flight simulation training devices
               1.   Flight simulation training devices (FSTDs) used for pilot training, testing and checking, with the exception of developmental training devices used for flight test training, shall comply with the technical requirements and administrative procedures laid down in Annexes VI and VII and shall be qualified.
               2.   JAR-compliant FSTD qualification certificates issued or recognised before this Regulation applies shall be deemed to have been issued in accordance with this Regulation.
               3.   Member States shall replace the certificates referred to in paragraph 2 with qualification certificates complying with the format laid down in Annex VI by 8 April 2017 at the latest.
               Article 10c
               Aero-medical centres
               1.   Aero-medical centres shall comply with the technical requirements and administrative procedures laid down in Annexes VI and VII and shall be certified.
               2.   JAR-compliant aero-medical centre approvals issued or recognised by a Member State before this Regulation applies shall be deemed to have been issued in accordance with this Regulation.
               Aero-medical centres shall adapt their management system, training programmes, procedures and manuals to be compliant with Annex VII by 8 April 2014 at the latest.
               3.   Member States shall replace aero-medical centres’ approvals referred to in the first subparagraph of paragraph 2 with certificates complying with the format laid down in Annex VI by 8 April 2017 at the latest.’;
            
         
               (5)
            
            
               the following Articles 11a, 11b and 11c are inserted:
               ‘Article 11a
               Cabin crew qualifications and related attestations
               1.   Cabin crew members involved in commercial operation of aircraft referred to in Article 4(1)(b) and (c) of Regulation (EC) No 216/2008 shall be qualified and hold the related attestation in accordance with the technical requirements and administrative procedures laid down in Annexes V and VI.
               2.   Cabin crew members holding, before this Regulation applies, an attestation of safety training issued in accordance with Regulation (EEC) No 3922/91 (“EU-OPS”):
               
                           (a)
                        
                        
                           shall be deemed to be compliant with this Regulation if they comply with the applicable training, checking and recency requirements of EU-OPS; or
                        
                     
                           (b)
                        
                        
                           if they do not comply with the applicable training, checking and recency requirements of EU-OPS, they shall complete all required training and checking before being deemed to be compliant with this Regulation; or
                        
                     
                           (c)
                        
                        
                           if they have not operated in commercial operations by aeroplanes for more than 5 years, they shall complete the initial training course and shall pass the related examination as required in Annex V before being deemed to be compliant with this Regulation.
                        
                     3.   The attestations of safety training issued in accordance with EU-OPS shall be replaced with cabin crew attestations complying with the format laid down in Annex VI by 8 April 2017 at the latest.
               4.   Cabin crew members involved in commercial operations of helicopters on the date of application of this Regulation:
               
                           (a)
                        
                        
                           shall be deemed to be compliant with the initial training requirements of Annex V if they comply with the applicable training, checking and recency provisions of the JARs for commercial air transportation by helicopters; or
                        
                     
                           (b)
                        
                        
                           if they do not comply with the applicable training, checking and recency requirements of the JARs for commercial air transportation by helicopters, they shall complete all relevant training and checking required to operate on helicopter(s), except the initial training, before being deemed to be compliant with this Regulation; or
                        
                     
                           (c)
                        
                        
                           if they have not operated in commercial operations by helicopters for more than 5 years, they shall complete the initial training course and shall pass the related examination as required in Annex V before being deemed to be compliant with this Regulation.
                        
                     5.   Without prejudice to Article 2, cabin crew attestations complying with the format laid down in Annex VI shall be issued to all cabin crew members involved in commercial operations by helicopters by 8 April 2013 at the latest.
               Article 11b
               Oversight capabilities
               1.   Member States shall designate one or more entities as the competent authority within that Member State with the necessary powers and allocated responsibilities for the certification and oversight of persons and organisations subject to Regulation (EC) No 216/2008 and its implementing rules.
               2.   If a Member State designates more than one entity as competent authority:
               
                           (a)
                        
                        
                           the areas of competence of each competent authority shall be clearly defined in terms of responsibilities and geographic limitation;
                        
                     
                           (b)
                        
                        
                           coordination shall be established between those entities to ensure effective oversight of all organisations and persons subject to Regulation (EC) No 216/2008 and its implementing rules within their respective remits.
                        
                     3.   Member States shall ensure that the competent authority(ies) has/have the necessary capability to ensure the oversight of all persons and organisations covered by their oversight programme, including sufficient resources to fulfil the requirements of this Regulation.
               4.   Member States shall ensure that competent authority personnel do not perform oversight activities when there is evidence that this could result directly or indirectly in a conflict of interest, in particular when relating to family or financial interest.
               5.   Personnel authorised by the competent authority to carry out certification and/or oversight tasks shall be empowered to perform at least the following tasks:
               
                           (a)
                        
                        
                           examine the records, data, procedures and any other material relevant to the execution of the certification and/or oversight task;
                        
                     
                           (b)
                        
                        
                           take copies of or extracts from such records, data, procedures and other material;
                        
                     
                           (c)
                        
                        
                           ask for an oral explanation on site;
                        
                     
                           (d)
                        
                        
                           enter relevant premises, operating sites or means of transport;
                        
                     
                           (e)
                        
                        
                           perform audits, investigations, assessments and inspections, including ramp inspections and unannounced inspections; and
                        
                     
                           (f)
                        
                        
                           take or initiate enforcement measures as appropriate.
                        
                     6.   The tasks under paragraph 5 shall be carried out in compliance with the legal provisions of the relevant Member State.
               Article 11c
               Transitional measures
               As regards organisations for which the Agency is the competent authority in accordance with Article 21(1)(b) of Regulation (EC) No 216/2008:
               
                           (a)
                        
                        
                           Member States shall transfer to the Agency all records related to the oversight of such organisations by 8 April 2013 at the latest;
                        
                     
                           (b)
                        
                        
                           certification processes initiated before 8 April 2012 by a Member State shall be finalised by that Member State in coordination with the Agency. The Agency shall assume all its responsibilities as competent authority concerning such organisation after the issuance of the certificate by that Member State.’;
                        
                     
         
               (6)
            
            
               in Article 12, the following paragraph shall be added:
               ‘1b.   By way of derogation from paragraph 1, Member States may decide not to apply the provisions of Annexes I to IV until 8 April 2013.’;
            
         
               (7)
            
            
               in Article 12(7), the expression ‘paragraphs 2 to 6’ is replaced by ‘paragraphs 1b to 6’;
            
         
               (8)
            
            
               new Annexes V, VI and VII, the text of which is set out in the Annex to this Regulation, are added.
            
         Article 2
   1.   This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   It shall apply from 8 April 2012.
   2.   By way of derogation from the second subparagraph of paragraph 1, Member States may decide not to apply the following provisions:
   
               (a)
            
            
               Annexes V to VII until 8 April 2013;
            
         
               (b)
            
            
               point ORA.GEN.200(a)(3) of Annex VII to FSTD qualification certificate holders not being an approved training organisation and not holding an air operator certificate until 8 April 2014;
            
         
               (c)
            
            
               Annexes VI and VII to non-JAR-compliant approved training organisations and aero-medical centres until 8 April 2014;
            
         
               (d)
            
            
               point CC.GEN.030 of Annex V until 8 April 2015;
            
         
               (e)
            
            
               Annex V to cabin crew members involved in commercial operations by helicopters until 8 April 2015;
            
         
               (f)
            
            
               Annexes VI and VII to training organisations providing training only for the light aircraft pilot licence, private pilot licence, balloon pilot licence or sailplane pilot licence until 8 April 2015;
            
         
               (g)
            
            
               Annexes VI and VII to training organisations providing training for flight test ratings in accordance with point FCL.820 of Annex I to Regulation (EU) No 1178/2011 until 8 April 2015.
            
         3.   When a Member State makes use of the provisions of paragraph 2, it shall notify the Commission and the Agency. This notification shall describe the duration and the reasons for such derogation as well as the programme for implementation containing actions envisaged and related timing.
   
      This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.
      Done at Brussels, 30 March 2012.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 79, 13.3.2008, p. 1.
   
      (2)  OJ L 311, 25.11.2011, p. 1.
   
      (3)  OJ L 373, 31.12.1991, p. 4.
   
      ANNEX
      ‘
            ANNEX V
            
               QUALIFICATION OF CABIN CREW INVOLVED IN COMMERCIAL AIR TRANSPORT OPERATIONS
            
            
               [PART-CC]
            
            SUBPART GEN
            
               
                  GENERAL REQUIREMENTS
               
            
            
               CC.GEN.001 Competent authority
            
            For the purpose of this Part, the competent authority shall be the authority designated by the Member State where a person applies for the issue of a cabin crew attestation.
            
               CC.GEN.005 Scope
            
            This Part establishes the requirements for the issue of cabin crew attestations and the conditions for their validity and use by their holders.
            
               CC.GEN.015 Application for a cabin crew attestation
            
            The application for a cabin crew attestation shall be made in a form and manner established by the competent authority.
            
               CC.GEN.020 Minimum age
            
            The applicant for a cabin crew attestation shall be at least 18 years of age.
            
               CC.GEN.025 Privileges and conditions
            
            
                        (a)
                     
                     
                        The privileges of holders of a cabin crew attestation are to act as cabin crew members in commercial air transport operation of aircraft referred to in Article 4(1)(b) and (c) of Regulation (EC) No 216/2008.
                     
                  
                        (b)
                     
                     
                        Cabin crew members may exercise the privileges specified in (a) only if they:
                        
                                    (1)
                                 
                                 
                                    hold a valid cabin crew attestation as specified in CC.CCA.105; and
                                 
                              
                                    (2)
                                 
                                 
                                    comply with CC.GEN.030, CC.TRA.225 and the applicable requirements of Part-MED.
                                 
                              
                  
               CC.GEN.030 Documents and record-keeping
            
            To show compliance with the applicable requirements as specified in CC.GEN.025(b), each holder shall keep, and provide upon request, the cabin crew attestation, the list and the training and checking records of his/her aircraft type or variant qualification(s), unless the operator employing his/her services keeps such records and can make them readily available upon request by a competent authority or by the holder.
            SUBPART CCA
            
               
                  SPECIFIC REQUIREMENTS FOR THE CABIN CREW ATTESTATION
               
            
            
               CC.CCA.100 Issue of the cabin crew attestation
            
            
                        (a)
                     
                     
                        Cabin crew attestations shall only be issued to applicants who have passed the examination following completion of the initial training course in accordance with this Part.
                     
                  
                        (b)
                     
                     
                        Cabin crew attestations shall be issued:
                        
                                    (1)
                                 
                                 
                                    by the competent authority; and/or
                                 
                              
                                    (2)
                                 
                                 
                                    by an organisation approved to do so by the competent authority.
                                 
                              
                  
               CC.CCA.105 Validity of the cabin crew attestation
            
            The cabin crew attestation shall be issued with unlimited duration and shall remain valid unless:
            
                        (a)
                     
                     
                        it is suspended or revoked by the competent authority; or
                     
                  
                        (b)
                     
                     
                        its holder has not exercised the associated privileges during the preceding 60 months on at least one aircraft type.
                     
                  
               CC.CCA.110 Suspension and revocation of the cabin crew attestation
            
            
                        (a)
                     
                     
                        If holders do not comply with this Part, their cabin crew attestation may be suspended or revoked by the competent authority.
                     
                  
                        (b)
                     
                     
                        In case of suspension or revocation of their cabin crew attestation by the competent authority, holders shall:
                        
                                    (1)
                                 
                                 
                                    be informed in writing of this decision, and of their right of appeal in accordance with national law;
                                 
                              
                                    (2)
                                 
                                 
                                    not exercise the privileges granted by their cabin crew attestation;
                                 
                              
                                    (3)
                                 
                                 
                                    inform, without undue delay, the operator(s) employing their services; and
                                 
                              
                                    (4)
                                 
                                 
                                    return their attestation in accordance with the applicable procedure established by the competent authority.
                                 
                              
                  SUBPART TRA
            
               
                  TRAINING REQUIREMENTS FOR CABIN CREW ATTESTATION APPLICANTS AND HOLDERS
               
            
            
               CC.TRA.215 Provision of training
            
            Training required in this Part shall be:
            
                        (a)
                     
                     
                        provided by training organisations or commercial air transport operators approved to do so by the competent authority;
                     
                  
                        (b)
                     
                     
                        performed by personnel suitably experienced and qualified for the training elements to be covered; and
                     
                  
                        (c)
                     
                     
                        conducted according to a training programme and syllabus documented in the organisation's approval.
                     
                  
               CC.TRA.220 Initial training course and examination
            
            
                        (a)
                     
                     
                        Applicants for a cabin crew attestation shall complete an initial training course to familiarise themselves with the aviation environment and to acquire sufficient general knowledge and basic proficiency required to perform the duties and discharge the responsibilities related to the safety of passengers and flight during normal, abnormal and emergency operations.
                     
                  
                        (b)
                     
                     
                        The programme of the initial training course shall cover at least the elements specified in Appendix 1 to this Part. It shall include theoretical and practical training.
                     
                  
                        (c)
                     
                     
                        Applicants for a cabin crew attestation shall undergo an examination covering all elements of the training programme specified in (b), except CRM training, to demonstrate that they have attained the level of knowledge and proficiency required in (a).
                     
                  
               CC.TRA.225 Aircraft type or variant qualification(s)
            
            
                        (a)
                     
                     
                        Holders of a valid cabin crew attestation shall only operate on an aircraft if they are qualified in accordance with the applicable requirements of Part-ORO.
                     
                  
                        (b)
                     
                     
                        To be qualified for an aircraft type or a variant, the holder:
                        
                                    (1)
                                 
                                 
                                    shall comply with the applicable training, checking and validity requirements, covering as relevant to the aircraft to be operated:
                                    
                                                (i)
                                             
                                             
                                                aircraft-type specific training, operator conversion training and familiarisation;
                                             
                                          
                                                (ii)
                                             
                                             
                                                differences training;
                                             
                                          
                                                (iii)
                                             
                                             
                                                recurrent training; and
                                             
                                          
                              
                                    (2)
                                 
                                 
                                    shall have operated within the preceding 6 months on the aircraft type, or shall have completed the relevant refresher training and checking before operating again on that aircraft type.
                                 
                              
                  
         
            Appendix 1 to Part-CC
            
               Initial training course and examination
            
            TRAINING PROGRAMME
            The training programme of the initial training course shall include at least the following:
            1.   General theoretical knowledge of aviation and aviation regulations covering all elements relevant to the duties and responsibilities required from cabin crew:
            
            
                        1.1.
                     
                     
                        aviation terminology, theory of flight, passenger distribution, areas of operation, meteorology and effects of aircraft surface contamination;
                     
                  
                        1.2.
                     
                     
                        aviation regulations relevant to cabin crew and the role of the competent authority;
                     
                  
                        1.3.
                     
                     
                        duties and responsibilities of cabin crew during operations and the need to respond promptly and effectively to emergency situations;
                     
                  
                        1.4.
                     
                     
                        continuing competence and fitness to operate as a cabin crew member, including as regards flight and duty time limitations and rest requirements;
                     
                  
                        1.5.
                     
                     
                        the importance of ensuring that relevant documents and manuals are kept up-to-date, with amendments provided by the operator as applicable;
                     
                  
                        1.6.
                     
                     
                        the importance of cabin crew performing their duties in accordance with the operations manual of the operator;
                     
                  
                        1.7.
                     
                     
                        the importance of the cabin crew’s pre-flight briefing and the provision of necessary safety information with regards to their specific duties; and
                     
                  
                        1.8.
                     
                     
                        the importance of identifying when cabin crew members have the authority and responsibility to initiate an evacuation and other emergency procedures.
                     
                  2.   Communication:
            
            During training, emphasis shall be placed on the importance of effective communication between cabin crew and flight crew, including communication techniques, common language and terminology.
            3.   Introductory course on human factors (HF) in aviation and crew resource management (CRM)
            
            This course shall be conducted by at least one cabin crew CRM instructor. The training elements shall be covered in depth and shall include at least the following:
            
                        3.1.
                     
                     
                        
                           General: human factors in aviation, general instructions on CRM principles and objectives, human performance and limitations;
                     
                  
                        3.2.
                     
                     
                        
                           Relevant to the individual cabin crew member: personality awareness, human error and reliability, attitudes and behaviours, self-assessment; stress and stress management; fatigue and vigilance; assertiveness; situation awareness, information acquisition and processing.
                     
                  4.   Passenger handling and cabin surveillance:
            
            
                        4.1.
                     
                     
                        the importance of correct seat allocation with reference to aeroplane mass and balance, special categories of passengers and the necessity of seating able-bodied passengers adjacent to unsupervised exits;
                     
                  
                        4.2.
                     
                     
                        rules covering the safe stowage of cabin baggage and cabin service items and the risk of it becoming a hazard to occupants of the passenger compartment or otherwise obstruction or damaging emergency equipment or exits;
                     
                  
                        4.3.
                     
                     
                        advice on the recognition and management of passengers who are, or become, intoxicated with alcohol or are under the influence of drugs or are aggressive;
                     
                  
                        4.4.
                     
                     
                        precautions to be taken when live animals are carried in the passenger compartment;
                     
                  
                        4.5.
                     
                     
                        duties to be undertaken in the event of turbulence, including securing the passenger compartment; and
                     
                  
                        4.6.
                     
                     
                        methods used to motivate passengers and the crowd control necessary to expedite an emergency evacuation.
                     
                  5.   Aero-medical aspects and first-aid:
            
            
                        5.1.
                     
                     
                        general instruction on aero-medical aspects and survival;
                     
                  
                        5.2.
                     
                     
                        the physiological effects of flying with particular emphasis on hypoxia, oxygen requirements, Eustachian tubal function and barotraumas;
                     
                  
                        5.3.
                     
                     
                        basic first-aid, including care of:
                        
                                    (a)
                                 
                                 
                                    air sickness;
                                 
                              
                                    (b)
                                 
                                 
                                    gastro-intestinal disturbances;
                                 
                              
                                    (c)
                                 
                                 
                                    hyperventilation;
                                 
                              
                                    (d)
                                 
                                 
                                    burns;
                                 
                              
                                    (e)
                                 
                                 
                                    wounds;
                                 
                              
                                    (f)
                                 
                                 
                                    the unconscious; and
                                 
                              
                                    (g)
                                 
                                 
                                    fractures and soft tissue injuries;
                                 
                              
                  
                        5.4.
                     
                     
                        in-flight medical emergencies and associated first-aid covering at least:
                        
                                    (a)
                                 
                                 
                                    asthma;
                                 
                              
                                    (b)
                                 
                                 
                                    stress and allergic reactions;
                                 
                              
                                    (c)
                                 
                                 
                                    shock;
                                 
                              
                                    (d)
                                 
                                 
                                    diabetes;
                                 
                              
                                    (e)
                                 
                                 
                                    choking;
                                 
                              
                                    (f)
                                 
                                 
                                    epilepsy;
                                 
                              
                                    (g)
                                 
                                 
                                    childbirth;
                                 
                              
                                    (h)
                                 
                                 
                                    stroke; and
                                 
                              
                                    (i)
                                 
                                 
                                    heart attack;
                                 
                              
                  
                        5.5.
                     
                     
                        the use of appropriate equipment including first-aid oxygen, first-aid kits and emergency medical kits and their contents;
                     
                  
                        5.6.
                     
                     
                        practical cardio-pulmonary resuscitation training by each cabin crew member using a specifically designed dummy and taking account of the characteristics of an aircraft environment; and
                     
                  
                        5.7.
                     
                     
                        travel health and hygiene, including:
                        
                                    (a)
                                 
                                 
                                    hygiene on board;
                                 
                              
                                    (b)
                                 
                                 
                                    risk of contact with infectious diseases and means to reduce such risks;
                                 
                              
                                    (c)
                                 
                                 
                                    handling of clinical waste;
                                 
                              
                                    (d)
                                 
                                 
                                    aircraft disinsection;
                                 
                              
                                    (e)
                                 
                                 
                                    handling of death on board; and
                                 
                              
                                    (f)
                                 
                                 
                                    alertness management, physiological effects of fatigue, sleep physiology, circadian rhythm and time zone changes.
                                 
                              
                  6.   Dangerous goods in accordance with the applicable ICAO Technical Instructions.
            7.   General security aspects in aviation, including awareness of the provisions laid down in Regulation (EC) No 300/2008.
            
            8.   Fire and smoke training:
            
            
                        8.1.
                     
                     
                        emphasis on the responsibility of cabin crew to deal promptly with emergencies involving fire and smoke and, in particular, emphasis on the importance of identifying the actual source of the fire;
                     
                  
                        8.2.
                     
                     
                        the importance of informing the flight crew immediately, as well as the specific actions necessary for coordination and assistance, when fire or smoke is discovered;
                     
                  
                        8.3.
                     
                     
                        the necessity for frequent checking of potential fire-risk areas including toilets, and the associated smoke detectors;
                     
                  
                        8.4.
                     
                     
                        the classification of fires and the appropriate type of extinguishing agents and procedures for particular fire situations;
                     
                  
                        8.5.
                     
                     
                        the techniques of application of extinguishing agents, the consequences of misapplication, and of use in a confined space including practical training in fire-fighting and in the donning and use of smoke protection equipment used in aviation; and
                     
                  
                        8.6.
                     
                     
                        the general procedures of ground-based emergency services at aerodromes.
                     
                  9.   Survival training:
            
            
                        9.1.
                     
                     
                        principles of survival in hostile environments (e.g. polar, desert, jungle, sea); and
                     
                  
                        9.2.
                     
                     
                        water survival training which shall include the actual donning and use of personal flotation equipment in water and the use of slide-rafts or similar equipment, as well as actual practice in water.
                     
                  
         
            ANNEX VI
            
               AUTHORITY REQUIREMENTS FOR AIRCREW
            
            
               [PART-ARA]
            
            SUBPART GEN
            
               
                  GENERAL REQUIREMENTS
               
            
            
               SECTION I
            
            
               
                  General
               
            
            
               ARA.GEN.105   Definitions
            
            For the purposes of this Part and of Part-ORA, the following definitions apply:
            
                        1.
                     
                     
                        “Acceptable Means of Compliance (AMC)” are non-binding standards adopted by the Agency to illustrate means to establish compliance with the Basic Regulation and its Implementing Rules;
                     
                  
                        2.
                     
                     
                        “Alternative means of compliance” are those that propose an alternative to an existing AMC or those that propose new means to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules for which no associated AMC have been adopted by the Agency;
                     
                  
                        3.
                     
                     
                        “Approved training organisation (ATO)” means an organisation qualified for the issue or continuation of an approval to provide training for pilot licences and associated ratings and certificates;
                     
                  
                        4.
                     
                     
                        “Basic instrument training device model (BITD model)” means a defined hardware and software combination, which has obtained a BITD qualification;
                     
                  
                        5.
                     
                     
                        “Certification specifications (CS)” are technical standards adopted by the Agency indicating means to show compliance with the Basic Regulation and its Implementing Rules and which can be used by organisation for the purpose of certification;
                     
                  
                        6.
                     
                     
                        “Flight instructor (FI)” means an instructor with the privileges to provide training in an aircraft, in accordance with Part-FCL;
                     
                  
                        7.
                     
                     
                        “Flight simulation training device (FSTD)” means a training device which is:
                        
                                    (a)
                                 
                                 
                                    in the case of aeroplanes, a full flight simulator (FFS), a flight training device (FTD), a flight and navigation procedures trainer (FNPT), or a basic instrument training device (BITD);
                                 
                              
                                    (b)
                                 
                                 
                                    in the case of helicopters, a full flight simulator (FFS), a flight training device (FTD) or a flight and navigation procedures trainer (FNPT);
                                 
                              
                  
                        8.
                     
                     
                        “FSTD qualification” means the level of technical ability of an FSTD as defined in the compliance document;
                     
                  
                        9.
                     
                     
                        “FSTD user” means the organisation or person requesting training, checking or testing through the use of an FSTD to an ATO;
                     
                  
                        10.
                     
                     
                        “Grounding” means the formal prohibition of an aircraft to take-off and the taking of such steps as are necessary to detain it;
                     
                  
                        11.
                     
                     
                        “Guidance Material (GM)” means non-binding material developed by the Agency that helps to illustrate the meaning of a requirement or specification and is used to support the interpretation of the Basic Regulation, its Implementing Rules and AMC;
                     
                  
                        12.
                     
                     
                        “ARO.RAMP” means the Subpart RAMP of Annex II to the Regulation on Air Operations;
                     
                  
                        13.
                     
                     
                        “Other training device (OTD)” means an aid used for pilot training other than an FSTD that provides for training where a complete flight deck or cockpit environment is not necessary;
                     
                  
                        14.
                     
                     
                        “Part-ARA” means Annex VI to the Regulation on Civil Aviation Aircrew;
                     
                  
                        15.
                     
                     
                        “Part-ORO” means Annex III to the Regulation on Air Operations;
                     
                  
                        16.
                     
                     
                        “Part-CC” means Annex V to the Regulation on Civil Aviation Aircrew;
                     
                  
                        17.
                     
                     
                        “Part-FCL” means Annex I to the Regulation on Civil Aviation Aircrew;
                     
                  
                        18.
                     
                     
                        “Part-MED” means Annex IV to the Regulation on Civil Aviation Aircrew;
                     
                  
                        19.
                     
                     
                        “Part-ORA” means Annex VII to the Regulation on Civil Aviation Aircrew;
                     
                  
                        20.
                     
                     
                        “Principal place of business” means the head office or registered office of the organisation within which the principal financial functions and operational control of the activities referred to in this Regulation are exercised;
                     
                  
                        21.
                     
                     
                        “Qualification test guide (QTG)” means a document designed to demonstrate that the performance and handling qualities of an FSTD represent those of the aircraft, class of aeroplane or type of helicopter, simulated within prescribed limits and that all applicable requirements have been met. The QTG includes both the data of the aircraft, class of aeroplane or type of helicopter and FSTD data used to support the validation.
                     
                  
               ARA.GEN.115   Oversight documentation
            
            The competent authority shall provide all legislative acts, standards, rules, technical publications and related documents to relevant personnel in order to allow them to perform their tasks and to discharge their responsibilities.
            
               ARA.GEN.120   Means of compliance
            
            
                        (a)
                     
                     
                        The Agency shall develop Acceptable Means of Compliance (AMC) that may be used to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules. When the AMC are complied with, the related requirements of the Implementing Rules are met.
                     
                  
                        (b)
                     
                     
                        Alternative means of compliance may be used to establish compliance with the Implementing Rules.
                     
                  
                        (c)
                     
                     
                        The competent authority shall establish a system to consistently evaluate that all alternative means of compliance used by itself or by organisations and persons under its oversight allow the establishment of compliance with Regulation (EC) No 216/2008 and its Implementing Rules.
                     
                  
                        (d)
                     
                     
                        The competent authority shall evaluate all alternative means of compliance proposed by an organisation in accordance with ORA.GEN.120 by analysing the documentation provided and, if considered necessary, conducting an inspection of the organisation.
                        When the competent authority finds that the alternative means of compliance are in accordance with the Implementing Rules, it shall without undue delay:
                        
                                    (1)
                                 
                                 
                                    notify the applicant that the alternative means of compliance may be implemented and, if applicable, amend the approval or certificate of the applicant accordingly; and
                                 
                              
                                    (2)
                                 
                                 
                                    notify the Agency of their content, including copies of all relevant documentation;
                                 
                              
                                    (3)
                                 
                                 
                                    inform other MS about alternative means of compliance that were accepted.
                                 
                              
                  
                        (e)
                     
                     
                        When the competent authority itself uses alternative means of compliance to achieve compliance with Regulation (EC) No 216/2008 and its Implementing Rules it shall:
                        
                                    (1)
                                 
                                 
                                    make them available to all organisations and persons under its oversight; and
                                 
                              
                                    (2)
                                 
                                 
                                    without undue delay notify the Agency.
                                 
                              The competent authority shall provide the Agency with a full description of the alternative means of compliance, including any revisions to procedures that may be relevant, as well as an assessment demonstrating that the Implementing Rules are met.
                     
                  
               ARA.GEN.125   Information to the Agency
            
            
                        (a)
                     
                     
                        The competent authority shall without undue delay notify the Agency in case of any significant problems with the implementation of Regulation (EC) No 216/2008 and its Implementing Rules.
                     
                  
                        (b)
                     
                     
                        The competent authority shall provide the Agency with safety-significant information stemming from the occurrence reports it has received.
                     
                  
               ARA.GEN.135   Immediate reaction to a safety problem
            
            
                        (a)
                     
                     
                        Without prejudice to Directive 2003/42/EC of the European Parliament and of the Council (1) the competent authority shall implement a system to appropriately collect, analyse and disseminate safety information.
                     
                  
                        (b)
                     
                     
                        The Agency shall implement a system to appropriately analyse any relevant safety information received and without undue delay provide to Member States and the Commission any information, including recommendations or corrective actions to be taken, necessary for them to react in a timely manner to a safety problem involving products, parts, appliances, persons or organisations subject to Regulation (EC) No 216/2008 and its Implementing Rules.
                     
                  
                        (c)
                     
                     
                        Upon receiving the information referred to in (a) and (b), the competent authority shall take adequate measures to address the safety problem.
                     
                  
                        (d)
                     
                     
                        Measures taken under (c) shall immediately be notified to all persons or organisations which need to comply with them under Regulation (EC) No 216/2008 and its Implementing Rules. The competent authority shall also notify those measures to the Agency and, when combined action is required, the other Member States concerned.
                     
                  
               SECTION II
            
            
               
                  Management
               
            
            
               ARA.GEN.200   Management system
            
            
                        (a)
                     
                     
                        The competent authority shall establish and maintain a management system, including as a minimum:
                        
                                    (1)
                                 
                                 
                                    documented policies and procedures to describe its organisation, means and methods to achieve compliance with Regulation (EC) No 216/2008 and its Implementing Rules. The procedures shall be kept up-to-date and serve as the basic working documents within that competent authority for all related tasks;
                                 
                              
                                    (2)
                                 
                                 
                                    a sufficient number of personnel to perform its tasks and discharge its responsibilities. Such personnel shall be qualified to perform their allocated tasks and have the necessary knowledge, experience, initial and recurrent training to ensure continuing competence. A system shall be in place to plan the availability of personnel, in order to ensure the proper completion of all tasks;
                                 
                              
                                    (3)
                                 
                                 
                                    adequate facilities and office accommodation to perform the allocated tasks;
                                 
                              
                                    (4)
                                 
                                 
                                    a function to monitor compliance of the management system with the relevant requirements and adequacy of the procedures including the establishment of an internal audit process and a safety risk management process. Compliance monitoring shall include a feedback system of audit findings to the senior management of the competent authority to ensure implementation of corrective actions as necessary; and
                                 
                              
                                    (5)
                                 
                                 
                                    a person or group of persons, ultimately responsible to the senior management of the competent authority for the compliance monitoring function.
                                 
                              
                  
                        (b)
                     
                     
                        The competent authority shall, for each field of activity including management system, appoint one or more persons with the overall responsibility for the management of the relevant task(s).
                     
                  
                        (c)
                     
                     
                        The competent authority shall establish procedures for participation in a mutual exchange of all necessary information and assistance with other competent authorities concerned including on all findings raised and follow-up actions taken as a result of oversight of persons and organisations exercising activities in the territory of a Member State, but certified by the competent authority of another Member State or the Agency.
                     
                  
                        (d)
                     
                     
                        A copy of the procedures related to the management system and their amendments shall be made available to the Agency for the purpose of standardisation.
                     
                  
               ARA.GEN.205   Allocation of tasks to qualified entities
            
            
                        (a)
                     
                     
                        Tasks related to the initial certification or continuing oversight of persons or organisations subject to Regulation (EC) No 216/2008 and its Implementing Rules shall be allocated by Member States only to qualified entities. When allocating tasks, the competent authority shall ensure that it has:
                        
                                    (1)
                                 
                                 
                                    a system in place to initially and continuously assess that the qualified entity complies with Annex V to Regulation (EC) No 216/2008.
                                    This system and the results of the assessments shall be documented;
                                 
                              
                                    (2)
                                 
                                 
                                    established a documented agreement with a the qualified entity, approved by both parties at the appropriate management level, which clearly defines:
                                    
                                                (i)
                                             
                                             
                                                the tasks to be performed;
                                             
                                          
                                                (ii)
                                             
                                             
                                                the declarations, reports and records to be provided;
                                             
                                          
                                                (iii)
                                             
                                             
                                                the technical conditions to be met in performing such tasks;
                                             
                                          
                                                (iv)
                                             
                                             
                                                the related liability coverage; and
                                             
                                          
                                                (v)
                                             
                                             
                                                the protection given to information acquired in carrying out such tasks.
                                             
                                          
                              
                  
                        (b)
                     
                     
                        The competent authority shall ensure that the internal audit process and a safety risk management process required by ARA.GEN.200(a)(4) cover all certification or continuing oversight tasks performed on its behalf.
                     
                  
               ARA.GEN.210   Changes in the management system
            
            
                        (a)
                     
                     
                        The competent authority shall have a system in place to identify changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EC) No 216/2008 and its Implementing Rules. This system shall enable it to take action as appropriate to ensure that its management system remains adequate and effective.
                     
                  
                        (b)
                     
                     
                        The competent authority shall update its management system to reflect any change to Regulation (EC) No 216/2008 and its Implementing Rules in a timely manner, so as to ensure effective implementation.
                     
                  
                        (c)
                     
                     
                        The competent authority shall notify the Agency of changes affecting its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EC) No 216/2008 and its Implementing Rules.
                     
                  
               ARA.GEN.220   Record-keeping
            
            
                        (a)
                     
                     
                        The competent authority shall establish a system of record-keeping providing for adequate storage, accessibility and reliable traceability of:
                        
                                    (1)
                                 
                                 
                                    the management system’s documented policies and procedures;
                                 
                              
                                    (2)
                                 
                                 
                                    training, qualification and authorisation of its personnel;
                                 
                              
                                    (3)
                                 
                                 
                                    the allocation of tasks, covering the elements required by ARA.GEN.205 as well as the details of tasks allocated;
                                 
                              
                                    (4)
                                 
                                 
                                    certification processes and continuing oversight of certified organisations;
                                 
                              
                                    (5)
                                 
                                 
                                    processes for issuing personnel licences, ratings, certificates and attestations and for the continuing oversight of the holders of those licences, ratings, certificates and attestations;
                                 
                              
                                    (6)
                                 
                                 
                                    processes for issuing FSTD qualification certificates and for the continuing oversight of the FSTD and of the organisation operating it;
                                 
                              
                                    (7)
                                 
                                 
                                    oversight of persons and organisations exercising activities within the territory of the Member State, but overseen or certified by the competent authority of another Member State or the Agency, as agreed between these authorities;
                                 
                              
                                    (8)
                                 
                                 
                                    the evaluation and notification to the Agency of alternative means of compliance proposed by organisations and the assessment of alternative means of compliance used by the competent authority itself;
                                 
                              
                                    (9)
                                 
                                 
                                    findings, corrective actions and date of action closure;
                                 
                              
                                    (10)
                                 
                                 
                                    enforcement measures taken;
                                 
                              
                                    (11)
                                 
                                 
                                    safety information and follow-up measures; and
                                 
                              
                                    (12)
                                 
                                 
                                    the use of flexibility provisions in accordance with Article 14 of Regulation (EC) No 216/2008.
                                 
                              
                  
                        (b)
                     
                     
                        The competent authority shall maintain a list of all organisation certificates, FSTD qualification certificates and personnel licences, certificates and attestations it issued.
                     
                  
                        (c)
                     
                     
                        All records shall be kept for the minimum period specified in this Regulation. In the absence of such indication, records shall be kept for a minimum period of 5 years subject to applicable data protection law.
                     
                  
               SECTION III
            
            
               
                  Oversight, certification and enforcement
               
            
            
               ARA.GEN.300   Oversight
            
            
                        (a)
                     
                     
                        The competent authority shall verify:
                        
                                    (1)
                                 
                                 
                                    compliance with the requirements applicable to organisations or persons prior to the issue of an organisation certificate, approval, FSTD qualification certificate or personnel licence, certificate, rating, or attestation, as applicable;
                                 
                              
                                    (2)
                                 
                                 
                                    continued compliance with the applicable requirements of organisations it has certified, of persons and of FSTD qualification certificate holders;
                                 
                              
                                    (3)
                                 
                                 
                                    implementation of appropriate safety measures mandated by the competent authority as defined in ARA.GEN.135(c) and (d).
                                 
                              
                  
                        (b)
                     
                     
                        This verification shall:
                        
                                    (1)
                                 
                                 
                                    be supported by documentation specifically intended to provide personnel responsible for safety oversight with guidance to perform their functions;
                                 
                              
                                    (2)
                                 
                                 
                                    provide the persons and organisations concerned with the results of safety oversight activity;
                                 
                              
                                    (3)
                                 
                                 
                                    be based on audits and inspections, including ramp and unannounced inspections; and
                                 
                              
                                    (4)
                                 
                                 
                                    provide the competent authority with the evidence needed in case further action is required, including the measures foreseen by ARA.GEN.350 and ARA.GEN.355.
                                 
                              
                  
                        (c)
                     
                     
                        The scope of oversight defined in (a) and (b) shall take into account the results of past oversight activities and the safety priorities.
                     
                  
                        (d)
                     
                     
                        Without prejudice to the competences of the Member States and to their obligations as set out in ARO.RAMP, the scope of the oversight of activities performed in the territory of a Member State by persons or organisations established or residing in another Member State shall be determined on the basis of the safety priorities, as well as of past oversight activities.
                     
                  
                        (e)
                     
                     
                        Where the activity of a person or organisation involves more than one Member State or the Agency, the competent authority responsible for the oversight under (a) may agree to have oversight tasks performed by the competent authority(ies) of the Member State(s) where the activity takes place or by the Agency. Any person or organisation subject to such agreement shall be informed of its existence and of its scope.
                     
                  
                        (f)
                     
                     
                        The competent authority shall collect and process any information deemed useful for oversight, including for ramp and unannounced inspections.
                     
                  
               ARA.GEN.305   Oversight programme
            
            
                        (a)
                     
                     
                        The competent authority shall establish and maintain an oversight programme covering the oversight activities required by ARA.GEN.300 and by ARO.RAMP.
                     
                  
                        (b)
                     
                     
                        For organisations certified by the competent authority and FSTD qualification certificate holders, the oversight programme shall be developed taking into account the specific nature of the organisation, the complexity of its activities, the results of past certification and/or oversight activities and shall be based on the assessment of associated risks. It shall include within each oversight planning cycle:
                        
                                    (1)
                                 
                                 
                                    audits and inspections, including ramp and unannounced inspections as appropriate; and
                                 
                              
                                    (2)
                                 
                                 
                                    meetings convened between the accountable manager and the competent authority to ensure both remain informed of significant issues.
                                 
                              
                  
                        (c)
                     
                     
                        For organisations certified by the competent authority and FSTD qualification certificate holders an oversight planning cycle not exceeding 24 months shall be applied.
                        The oversight planning cycle may be reduced if there is evidence that the safety performance of the organisation or the FTSD qualification certificate holder has decreased.
                        The oversight planning cycle may be extended to a maximum of 36 months if the competent authority has established that, during the previous 24 months:
                        
                                    (1)
                                 
                                 
                                    the organisation has demonstrated an effective identification of aviation safety hazards and management of associated risks;
                                 
                              
                                    (2)
                                 
                                 
                                    the organisation has continuously demonstrated under ORA.GEN.130 that it has full control over all changes;
                                 
                              
                                    (3)
                                 
                                 
                                    no level 1 findings have been issued; and
                                 
                              
                                    (4)
                                 
                                 
                                    all corrective actions have been implemented within the time period accepted or extended by the competent authority as defined in ARA.GEN.350(d)(2).
                                 
                              The oversight planning cycle may be further extended to a maximum of 48 months if, in addition to the above, the organisation has established, and the competent authority has approved, an effective continuous reporting system to the competent authority on the safety performance and regulatory compliance of the organisation itself.
                     
                  
                        (d)
                     
                     
                        For persons holding a licence, certificate, rating, or attestation issued by the competent authority the oversight programme shall include inspections, including unannounced inspections, as appropriate.
                     
                  
                        (e)
                     
                     
                        The oversight programme shall include records of the dates when audits, inspections and meetings are due and when such audits, inspections and meetings have been carried out.
                     
                  
               ARA.GEN.310   Initial certification procedure – organisations
            
            
                        (a)
                     
                     
                        Upon receiving an application for the initial issue of a certificate for an organisation, the competent authority shall verify the organisation’s compliance with the applicable requirements.
                     
                  
                        (b)
                     
                     
                        When satisfied that the organisation is in compliance with the applicable requirements, the competent authority shall issue the certificate(s), as established in Appendixes III and V to this Part. The certificate(s) shall be issued for an unlimited duration. The privileges and scope of the activities that the organisation is approved to conduct shall be specified in the terms of approval attached to the certificate(s).
                     
                  
                        (c)
                     
                     
                        To enable an organisation to implement changes without prior competent authority approval in accordance with ORA.GEN.130, the competent authority shall approve the procedure submitted by the organisation defining the scope of such changes and describing how such changes will be managed and notified.
                     
                  
               ARA.GEN.315   Procedure for issue, revalidation, renewal or change of licences, ratings, certificates or attestations – persons
            
            
                        (a)
                     
                     
                        Upon receiving an application for the issue, revalidation, renewal or change of a personal licence, rating, certificate or attestation and any supporting documentation, the competent authority shall verify whether the applicant meets the applicable requirements.
                     
                  
                        (b)
                     
                     
                        When satisfied that the applicant meets the applicable requirements, the competent authority shall issue, revalidate, renew or change the licence, certificate, rating, or attestation.
                     
                  
               ARA.GEN.330   Changes – organisations
            
            
                        (a)
                     
                     
                        Upon receiving an application for a change that requires prior approval, the competent authority shall verify the organisation’s compliance with the applicable requirements before issuing the approval.
                        The competent authority shall prescribe the conditions under which the organisation may operate during the change, unless the competent authority determines that the organisation’s certificate needs to be suspended.
                        When satisfied that the organisation is in compliance with the applicable requirements, the competent authority shall approve the change.
                     
                  
                        (b)
                     
                     
                        Without prejudice to any additional enforcement measures, when the organisation implements changes requiring prior approval without having received competent authority approval as defined in (a), the competent authority shall suspend, limit or revoke the organisation’s certificate.
                     
                  
                        (c)
                     
                     
                        For changes not requiring prior approval, the competent authority shall assess the information provided in the notification sent by the organisation in accordance with ORA.GEN.130 to verify compliance with the applicable requirements. In case of any non-compliance, the competent authority shall:
                        
                                    (1)
                                 
                                 
                                    notify the organisation about the non-compliance and request further changes; and
                                 
                              
                                    (2)
                                 
                                 
                                    in case of level 1 or level 2 findings, act in accordance with ARA.GEN.350.
                                 
                              
                  
               ARA.GEN.350   Findings and corrective actions – organisations
            
            
                        (a)
                     
                     
                        The competent authority for oversight in accordance with ARA.GEN.300 (a) shall have a system to analyse findings for their safety significance.
                     
                  
                        (b)
                     
                     
                        A level 1 finding shall be issued by the competent authority when any significant non-compliance is detected with the applicable requirements of Regulation (EC) No 216/2008 and its Implementing Rules, with the organisation’s procedures and manuals or with the terms of an approval or certificate which lowers safety or seriously hazards flight safety.
                        The level 1 findings shall include:
                        
                                    (1)
                                 
                                 
                                    failure to give the competent authority access to the organisation’s facilities as defined in ORA.GEN.140 during normal operating hours and after two written requests;
                                 
                              
                                    (2)
                                 
                                 
                                    obtaining or maintaining the validity of the organisation certificate by falsification of submitted documentary evidence;
                                 
                              
                                    (3)
                                 
                                 
                                    evidence of malpractice or fraudulent use of the organisation certificate; and
                                 
                              
                                    (4)
                                 
                                 
                                    the lack of an accountable manager.
                                 
                              
                  
                        (c)
                     
                     
                        A level 2 finding shall be issued by the competent authority when any non-compliance is detected with the applicable requirements of Regulation (EC) No 216/2008 and its Implementing Rules, with the organisation’s procedures and manuals or with the terms of an approval or certificate which could lower safety or hazard flight safety.
                     
                  
                        (d)
                     
                     
                        When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EC) No 216/2008 and its Implementing Rules, communicate the finding to the organisation in writing and request corrective action to address the non-compliance(s) identified. Where relevant, the competent authority shall inform the State in which the aircraft is registered.
                        
                                    (1)
                                 
                                 
                                    In the case of level 1 findings the competent authority shall take immediate and appropriate action to prohibit or limit activities and, if appropriate, it shall take action to revoke the certificate or specific approval or to limit or suspend it in whole or in part, depending upon the extent of the level 1 finding, until successful corrective action has been taken by the organisation.
                                 
                              
                                    (2)
                                 
                                 
                                    In the case of level 2 findings, the competent authority shall:
                                    
                                                (i)
                                             
                                             
                                                grant the organisation a corrective action implementation period appropriate to the nature of the finding that in any case initially shall not be more than 3 months. At the end of this period, and subject to the nature of the finding, the competent authority may extend the 3-month period subject to a satisfactory corrective action plan agreed by the competent authority; and
                                             
                                          
                                                (ii)
                                             
                                             
                                                assess the corrective action and implementation plan proposed by the organisation and, if the assessment concludes that they are sufficient to address the non-compliance(s), accept these.
                                             
                                          
                              
                                    (3)
                                 
                                 
                                    Where an organisation fails to submit an acceptable corrective action plan, or to perform the corrective action within the time period accepted or extended by the competent authority, the finding shall be raised to a level 1 finding and action taken as laid down in (d)(1).
                                 
                              
                                    (4)
                                 
                                 
                                    The competent authority shall record all findings it has raised or that have been communicated to it and, where applicable, the enforcement measures it has applied, as well as all corrective actions and date of action closure for findings.
                                 
                              
                  
                        (e)
                     
                     
                        Without prejudice to any additional enforcement measures, when the authority of a Member State acting under the provisions of ARA.GEN.300(d) identifies any non-compliance with the applicable requirements of Regulation (EC) No 216/2008 and its Implementing Rules by an organisation certified by the competent authority of another Member State or the Agency, it shall inform that competent authority and provide an indication of the level of finding.
                     
                  
               ARA.GEN.355   Findings and enforcement measures – persons
            
            
                        (a)
                     
                     
                        If, during oversight or by any other means, evidence is found by the competent authority responsible for oversight in accordance with ARA.GEN.300(a) that shows a non-compliance with the applicable requirements by a person holding a licence, certificate, rating or attestation issued in accordance with Regulation (EC) No 216/2008 and its Implementing Rules, the competent authority shall raise a finding, record it and communicate it in writing to the licence, certificate, rating or attestation holder.
                     
                  
                        (b)
                     
                     
                        When such finding is raised, the competent authority shall carry out an investigation. If the finding is confirmed, it shall:
                        
                                    (1)
                                 
                                 
                                    limit, suspend or revoke the licence, certificate, rating or attestation as applicable, when a safety issue has been identified; and
                                 
                              
                                    (2)
                                 
                                 
                                    take any further enforcement measures necessary to prevent the continuation of the non-compliance.
                                 
                              
                  
                        (c)
                     
                     
                        Where applicable, the competent authority shall inform the person or organisation that issued the medical certificate or attestation.
                     
                  
                        (d)
                     
                     
                        Without prejudice to any additional enforcement measures, when the authority of a Member State acting under the provisions of ARA.GEN.300(d) finds evidence showing a non-compliance with the applicable requirements by a person holding a licence, certificate, rating or attestation issued by the competent authority of any other Member State, it shall inform that competent authority.
                     
                  
                        (e)
                     
                     
                        If, during oversight or by any other means, evidence is found showing a non-compliance with the applicable requirements by a person subject to the requirements laid down in Regulation (EC) No 216/2008 and its Implementing Rules and not holding a licence, certificate, rating or attestation issued in accordance with that Regulation and its Implementing Rules, the competent authority that identified the non-compliance shall take any enforcement measures necessary to prevent the continuation of that non-compliance.
                     
                  SUBPART FCL
            
               
                  SPECIFIC REQUIREMENTS RELATING TO FLIGHT CREW LICENSING
               
            
            
               SECTION I
            
            
               
                  General
               
            
            
               ARA.FCL.120   Record-keeping
            
            In addition to the records required in ARA.GEN.220(a), the competent authority shall include in its system of record-keeping results of theoretical knowledge examinations and the assessments of pilots’ skills.
            
               SECTION II
            
            
               
                  Licences, ratings and certificates
               
            
            
               ARA.FCL.200   Procedure for issue, revalidation or renewal of a licence, rating or certificate
            
            
                        (a)
                     
                     
                        Issue of licences and ratings. The competent authority shall issue a pilot licence and associated ratings, using the form as established in Appendix I to this Part.
                     
                  
                        (b)
                     
                     
                        Issue of instructor and examiner certificates. The competent authority shall issue an instructor or examiner certificate as:
                        
                                    (1)
                                 
                                 
                                    an endorsement of the relevant privileges in the pilot licence as established in Appendix I to this Part; or
                                 
                              
                                    (2)
                                 
                                 
                                    a separate document, in a form and manner specified by the competent authority.
                                 
                              
                  
                        (c)
                     
                     
                        Endorsement of licence by examiners. Before specifically authorising certain examiners to revalidate or renew ratings or certificates, the competent authority shall develop appropriate procedures.
                     
                  
               ARA.FCL.205   Monitoring of examiners
            
            
                        (a)
                     
                     
                        The competent authority shall develop an oversight programme to monitor the conduct and performance of examiners taking into account:
                        
                                    (1)
                                 
                                 
                                    the number of examiners it has certified; and
                                 
                              
                                    (2)
                                 
                                 
                                    the number of examiners certified by other competent authorities exercising their privileges within the territory where the competent authority exercises oversight.
                                 
                              
                  
                        (b)
                     
                     
                        The competent authority shall maintain a list of examiners it has certified and of examiners certified by other competent authorities exercising their privileges in its territory and to which the competent authority has provided a briefing in accordance with FCL.1015(c)(2). The list shall state the privileges of the examiners and be published and kept updated by the competent authority.
                     
                  
                        (c)
                     
                     
                        The competent authority shall develop procedures to designate examiners for the conduct of skill tests.
                     
                  
               ARA.FCL.210   Information for examiners
            
            The competent authority may provide examiners it has certified and examiners certified by other competent authorities exercising their privileges in their territory with safety criteria to be observed when skill tests and proficiency checks are conducted in an aircraft.
            
               ARA.FCL.215   Validity period
            
            
                        (a)
                     
                     
                        When issuing or renewing a rating or certificate, the competent authority or, in the case of renewal, an examiner specifically authorised by the competent authority, shall extend the validity period until the end of the relevant month.
                     
                  
                        (b)
                     
                     
                        When revalidating a rating, an instructor or an examiner certificate, the competent authority, or an examiner specifically authorised by the competent authority, shall extend the validity period of the rating or certificate until the end of the relevant month.
                     
                  
                        (c)
                     
                     
                        The competent authority, or an examiner specifically authorised for that purpose by the competent authority, shall enter the expiry date on the licence or the certificate.
                     
                  
                        (d)
                     
                     
                        The competent authority may develop procedures to allow privileges to be exercised by the licence or certificate holder for a maximum period of 8 weeks after successful completion of the applicable examination(s), pending the endorsement on the licence or certificate.
                     
                  
               ARA.FCL.220   Procedure for the re-issue of a pilot licence
            
            
                        (a)
                     
                     
                        The competent authority shall re-issue a licence whenever necessary for administrative reasons and:
                        
                                    (1)
                                 
                                 
                                    after initial issue of a rating; or
                                 
                              
                                    (2)
                                 
                                 
                                    when paragraph XII of the licence established in Appendix I to this Part is completed and no further spaces remain.
                                 
                              
                  
                        (b)
                     
                     
                        Only valid ratings and certificates shall be transferred to the new licence document.
                     
                  
               ARA.FCL.250   Limitation, suspension or revocation of licences, ratings and certificates
            
            
                        (a)
                     
                     
                        The competent authority shall limit, suspend or revoke as applicable a pilot licence and associated ratings or certificates in accordance with ARA.GEN.355 in, but not limited to, the following circumstances:
                        
                                    (1)
                                 
                                 
                                    obtaining the pilot licence, rating or certificate by falsification of submitted documentary evidence;
                                 
                              
                                    (2)
                                 
                                 
                                    falsification of the logbook and licence or certificate records;
                                 
                              
                                    (3)
                                 
                                 
                                    the licence holder no longer complies with the applicable requirements of Part-FCL;
                                 
                              
                                    (4)
                                 
                                 
                                    exercising the privileges of a licence, rating or certificate when adversely affected by alcohol or drugs;
                                 
                              
                                    (5)
                                 
                                 
                                    non-compliance with the applicable operational requirements;
                                 
                              
                                    (6)
                                 
                                 
                                    evidence of malpractice or fraudulent use of the certificate; or
                                 
                              
                                    (7)
                                 
                                 
                                    unacceptable performance in any phase of the flight examiner’s duties or responsibilities.
                                 
                              
                  
                        (b)
                     
                     
                        The competent authority may also limit, suspend or revoke a licence, rating or certificate upon the written request of the licence or certificate holder.
                     
                  
                        (c)
                     
                     
                        All skill tests, proficiency checks or assessments of competence conducted during suspension or after the revocation of an examiner’s certificate will be invalid.
                     
                  
               SECTION III
            
            
               
                  Theoretical knowledge examinations
               
            
            
               ARA.FCL.300   Examination procedures
            
            
                        (a)
                     
                     
                        The competent authority shall put in place the necessary arrangements and procedures to allow applicants to undergo theoretical knowledge examinations in accordance with the applicable requirements of Part-FCL.
                     
                  
                        (b)
                     
                     
                        In the case of the ATPL, MPL, commercial pilot licence (CPL), and instrument ratings, those procedures shall comply with all of the following:
                        
                                    (1)
                                 
                                 
                                    Examinations shall be done in written or computer-based form.
                                 
                              
                                    (2)
                                 
                                 
                                    Questions for an examination shall be selected by the competent authority, according to a common method which allows coverage of the entire syllabus in each subject, from the European Central Question Bank (ECQB). The ECQB is a database of multiple choice questions held by the Agency.
                                 
                              
                                    (3)
                                 
                                 
                                    The examination in communications may be provided separately from those in other subjects. An applicant who has previously passed one or both of the examinations in visual flight rules (VFR) and instrument flight rules (IFR) communications shall not be re-examined in the relevant sections.
                                 
                              
                  
                        (c)
                     
                     
                        The competent authority shall inform applicants of the languages available for examinations.
                     
                  
                        (d)
                     
                     
                        The competent authority shall establish appropriate procedures to ensure the integrity of the examinations.
                     
                  
                        (e)
                     
                     
                        If the competent authority finds that the applicant is not complying with the examination procedures during the examination, this shall be assessed with a view to failing the applicant, either in the examination of a single subject or in the examination as a whole.
                     
                  
                        (f)
                     
                     
                        The competent authority shall ban applicants who are proven to be cheating from taking any further examination for a period of at least 12 months from the date of the examination in which they were found cheating.
                     
                  SUBPART CC
            
               
                  SPECIFIC REQUIREMENTS RELATING TO CABIN CREW
               
            
            
               SECTION I
            
            
               
                  Cabin crew attestations
               
            
            
               ARA.CC.100   Procedures for cabin crew attestations
            
            
                        (a)
                     
                     
                        The competent authority shall establish procedures for the issue, record-keeping and oversight of cabin crew attestations in accordance with ARA.GEN.315, ARA.GEN.220 and ARA.GEN.300 respectively.
                     
                  
                        (b)
                     
                     
                        Cabin crew attestations shall be issued, using the format and specifications established in Appendix II to this Part,
                        either
                        
                                    (1)
                                 
                                 
                                    by the competent authority;
                                    and/or, if so decided by a Member State
                                 
                              
                                    (2)
                                 
                                 
                                    by an organisation approved to do so by the competent authority.
                                 
                              
                  
                        (c)
                     
                     
                        The competent authority shall make publicly available:
                        
                                    (1)
                                 
                                 
                                    which body(ies) issue cabin crew attestations in their territory; and
                                 
                              
                                    (2)
                                 
                                 
                                    if organisations are approved to do so, the list of such organisations.
                                 
                              
                  
               ARA.CC.105   Suspension or revocation of cabin crew attestations
            
            The competent authority shall take measures in accordance with ARA.GEN.355, including the suspension or revocation of a cabin crew attestation, at least in the following cases:
            
                        (a)
                     
                     
                        non-compliance with Part-CC or with the applicable requirements of Part-ORO and Part-CAT, where a safety issue has been identified;
                     
                  
                        (b)
                     
                     
                        obtaining or maintaining the validity of the cabin crew attestation by falsification of submitted documentary evidence;
                     
                  
                        (c)
                     
                     
                        exercising the privileges of the cabin crew attestation when adversely affected by alcohol or drugs; and
                     
                  
                        (d)
                     
                     
                        evidence of malpractice or fraudulent use of the cabin crew attestation.
                     
                  
               SECTION II
            
            
               
                  Organisations providing cabin crew training or issuing cabin crew attestations
               
            
            
               ARA.CC.200   Approval of organisations to provide cabin crew training or to issue cabin crew attestations
            
            
                        (a)
                     
                     
                        Before issuing an approval to a training organisation or a commercial air transport operator to provide cabin crew training, the competent authority shall verify that:
                        
                                    (1)
                                 
                                 
                                    the conduct, the syllabi and associated programmes of the training courses provided by the organisation comply with the relevant requirements of Part-CC;
                                 
                              
                                    (2)
                                 
                                 
                                    the training devices used by the organisation realistically represent the passenger compartment environment of the aircraft type(s) and the technical characteristics of the equipment to be operated by the cabin crew; and
                                 
                              
                                    (3)
                                 
                                 
                                    the trainers and instructors conducting the training sessions are suitably experienced and qualified in the training subject covered.
                                 
                              
                  
                        (b)
                     
                     
                        If in a Member State organisations may be approved to issue cabin crew attestations, the competent authority shall only grant such approvals to organisations complying with the requirements in (a). Before granting such an approval, the competent authority shall:
                        
                                    (1)
                                 
                                 
                                    assess the capability and accountability of the organisation to perform the related tasks;
                                 
                              
                                    (2)
                                 
                                 
                                    ensure that the organisation has established documented procedures for the performance of the related tasks, including for the conduct of examination(s) by personnel who are qualified for this purpose and free from conflict of interest, and for the issue of cabin crew attestations in accordance with ARA.GEN.315 and ARA.CC.100(b); and
                                 
                              
                                    (3)
                                 
                                 
                                    require the organisation to provide information and documentation related to the cabin crew attestations it issues and their holders, as relevant for the competent authority to conduct its record-keeping, oversight and enforcement tasks.
                                 
                              
                  SUBPART ATO
            
               
                  SPECIFIC REQUIREMENTS RELATED TO APPROVED TRAINING ORGANISATIONS (ATOs)
               
            
            
               SECTION I
            
            
               
                  General
               
            
            
               ARA.ATO.105   Oversight Programme
            
            The oversight programme for ATOs shall include the monitoring of course standards, including the sampling of training flights with students, if appropriate to the aircraft used.
            
               ARA.ATO.120   Record-keeping
            
            In addition to the records required in ARA.GEN.220, the competent authority shall include in its system of record-keeping details of courses provided by the ATO, and if applicable, records relating to FSTDs used for training.
            SUBPART FSTD
            
               
                  SPECIFIC REQUIREMENTS RELATED TO THE QUALIFICATION OF FLIGHT SIMULATION TRAINING DEVICES (FSTDs)
               
            
            
               SECTION I
            
            
               
                  General
               
            
            
               ARA.FSTD.100   Initial evaluation procedure
            
            
                        (a)
                     
                     
                        Upon receiving an application for an FSTD qualification certificate, the competent authority shall:
                        
                                    (1)
                                 
                                 
                                    evaluate the FSTD submitted for initial evaluation or for upgrading against the applicable qualification basis;
                                 
                              
                                    (2)
                                 
                                 
                                    assess the FSTD in those areas that are essential to completing the flight crew member training, testing and checking process, as applicable;
                                 
                              
                                    (3)
                                 
                                 
                                    conduct objective, subjective and functions tests in accordance with the qualification basis and review the results of such tests to establish the qualification test guide (QTG); and
                                 
                              
                                    (4)
                                 
                                 
                                    verify if the organisation operating the FSTD is in compliance with the applicable requirements. This does not apply to the initial evaluation of basic instrument training devices (BITDs).
                                 
                              
                  
                        (b)
                     
                     
                        The competent authority shall only approve the QTG after completion of the initial evaluation of the FSTD and when all discrepancies in the QTG have been addressed to the satisfaction of the competent authority. The QTG resulting from the initial evaluation procedure shall be the master QTG (MQTG), which shall be the basis for the FSTD qualification and subsequent recurrent FSTD evaluations.
                     
                  
                        (c)
                     
                     
                        Qualification basis and special conditions.
                        
                                    (1)
                                 
                                 
                                    The competent authority may prescribe special conditions for the FSTD qualification basis when the requirements of ORA.FSTD.210(a) are met and when it is demonstrated that the special conditions ensure an equivalent level of safety to that established in the applicable certification specification.
                                 
                              
                                    (2)
                                 
                                 
                                    When the competent authority, if other than the Agency, has established special conditions for the qualification basis of an FSTD, it shall without undue delay notify the Agency thereof. The notification shall be accompanied by a full description of the special conditions prescribed, and a safety assessment demonstrating that an equivalent level of safety to that established in the applicable Certification Specification is met.
                                 
                              
                  
               ARA.FSTD.110   Issue of an FSTD qualification certificate
            
            
                        (a)
                     
                     
                        After completion of an evaluation of the FSTD and when satisfied that the FSTD meets the applicable qualification basis in accordance with ORA.FSTD.210 and that the organisation operating it meets the applicable requirements to maintain the qualification of the FSTD in accordance with ORA.FSTD.100, the competent authority shall issue the FSTD qualification certificate of unlimited duration, using the form as established in Appendix IV to this Part.
                     
                  
               ARA.FSTD.115   Interim FSTD qualification
            
            
                        (a)
                     
                     
                        In the case of the introduction of new aircraft programmes, when compliance with the requirements established in this Subpart for FSTD qualification is not possible, the competent authority may issue an interim FSTD qualification level.
                     
                  
                        (b)
                     
                     
                        For full flight simulators (FFS) an interim qualification level shall only be granted at level A, B or C.
                     
                  
                        (c)
                     
                     
                        This interim qualification level shall be valid until a final qualification level can be issued and, in any case, shall not exceed 3 years.
                     
                  
               ARA.FSTD.120   Continuation of an FSTD qualification
            
            
                        (a)
                     
                     
                        The competent authority shall continuously monitor the organisation operating the FSTD to verify that:
                        
                                    (1)
                                 
                                 
                                    the complete set of tests in the MQTG is rerun progressively over a 12-month period;
                                 
                              
                                    (2)
                                 
                                 
                                    the results of recurrent evaluations continue to comply with the qualification standards and are dated and retained; and
                                 
                              
                                    (3)
                                 
                                 
                                    a configuration control system is in place to ensure the continued integrity of the hardware and software of the qualified FSTD.
                                 
                              
                  
                        (b)
                     
                     
                        The competent authority shall conduct recurrent evaluations of the FSTD in accordance with the procedures detailed in ARA.FSTD.100. These evaluations shall take place:
                        
                                    (1)
                                 
                                 
                                    every year, in the case of a full flight simulator (FFS), flight training device (FTD) or flight and navigation procedures trainer (FNPT); the start for each recurrent 12-month period is the date of the initial qualification. The FSTD recurrent evaluation shall take place within the 60 days prior to the end of this 12-month recurrent evaluation period;
                                 
                              
                                    (2)
                                 
                                 
                                    every 3 years, in the case of a BITD.
                                 
                              
                  
               ARA.FSTD.130   Changes
            
            
                        (a)
                     
                     
                        Upon receipt of an application for any changes to the FSTD qualification certificate, the competent authority shall comply with the applicable elements of the initial evaluation procedure requirements as described in ARA.FSTD.100(a) and (b).
                     
                  
                        (b)
                     
                     
                        The competent authority may complete a special evaluation following major changes or when an FSTD appears not to be performing at its initial qualification level.
                     
                  
                        (c)
                     
                     
                        The competent authority shall always conduct a special evaluation before granting a higher level of qualification to the FSTD.
                     
                  
               ARA.FSTD.135   Findings and corrective actions – FSTD qualification certificate
            
            The competent authority shall limit, suspend or revoke, as applicable, an FSTD qualification certificate in accordance with ARA.GEN.350 in, but not limited to, the following circumstances:
            
                        (a)
                     
                     
                        obtaining the FSTD qualification certificate by falsification of submitted documentary evidence;
                     
                  
                        (b)
                     
                     
                        the organisation operating the FSTD can no longer demonstrate that the FSTD complies with its qualification basis; or
                     
                  
                        (c)
                     
                     
                        the organisation operating the FSTD no longer complies with the applicable requirements of Part-ORA.
                     
                  
               ARA.FSTD.140   Record keeping
            
            In addition to the records required in ARA.GEN.220, the competent authority shall keep and update a list of the qualified FSTDs under its supervision, the dates when evaluations are due and when such evaluations were carried out.
            SUBPART AeMC
            
               
                  SPECIFIC REQUIREMENTS RELATING TO AERO-MEDICAL CENTRES (AeMCs)
               
            
            
               SECTION I
            
            
               
                  General
               
            
            
               ARA.AeMC.110   Initial certification procedure
            
            The certification procedure for an AeMC shall follow the provisions laid down in ARA.GEN.310.
            
               ARA.AeMC.150   Findings and corrective actions – AeMC
            
            Without prejudice to ARA.GEN.350, level 1 findings include, but are not limited to, the following:
            
                        (a)
                     
                     
                        failure to nominate a head of the AeMC;
                     
                  
                        (b)
                     
                     
                        failure to ensure medical confidentiality of aero-medical records; and
                     
                  
                        (c)
                     
                     
                        failure to provide the competent authority with the medical and statistical data for oversight purposes.
                     
                  SUBPART MED
            
               
                  SPECIFIC REQUIREMENTS RELATING TO AERO-MEDICAL CERTIFICATION
               
            
            
               SECTION I
            
            
               
                  General
               
            
            
               ARA.MED.120   Medical assessors
            
            The competent authority shall appoint one or more medical assessor(s) to undertake the tasks described in this Section. The medical assessor shall be licensed and qualified in medicine and have:
            
                        (a)
                     
                     
                        postgraduate work experience in medicine of at least 5 years;
                     
                  
                        (b)
                     
                     
                        specific knowledge and experience in aviation medicine; and
                     
                  
                        (c)
                     
                     
                        specific training in medical certification.
                     
                  
               ARA.MED.125   Referral to the licensing authority
            
            When an AeMC, or aero-medical examiner (AME) has referred the decision on the fitness of an applicant to the licensing authority:
            
                        (a)
                     
                     
                        the medical assessor or medical staff designated by the competent authority shall evaluate the relevant medical documentation and request further medical documentation, examinations and tests where necessary; and
                     
                  
                        (b)
                     
                     
                        the medical assessor shall determine the applicant’s fitness for the issue of a medical certificate with one or more limitation(s) as necessary.
                     
                  
               ARA.MED.130   Medical certificate format
            
            The format of the medical certificate shall be in accordance with Appendix VI to this Part.
            
               ARA.MED.135   Aero-medical forms
            
            The competent authority shall use forms for:
            
                        (a)
                     
                     
                        the application form for a medical certificate;
                     
                  
                        (b)
                     
                     
                        the examination report form for class 1 and class 2 applicants; and
                     
                  
                        (c)
                     
                     
                        the examination report form for light aircraft pilot licence (LAPL) applicants.
                     
                  
               ARA.MED.145   GMP notification to the competent authority
            
            The competent authority, when applicable, shall establish a notification process for general medical practitioners (GMPs) to ensure that the GMP is aware of the medical requirements laid down in MED.B.095.
            
               ARA.MED.150   Record-keeping
            
            
                        (a)
                     
                     
                        In addition to the records required in ARA.GEN.220, the competent authority shall include in its system of record-keeping details of aero-medical examinations and assessments submitted by AMEs, AeMCs or GMPs.
                     
                  
                        (b)
                     
                     
                        All aero-medical records of licence holders shall be kept for a minimum period of 10 years after the expiry of their last medical certificate.
                     
                  
                        (c)
                     
                     
                        For the purpose of aero-medical assessments and standardisation, aero-medical records shall be made available after written consent of the applicant/licence holder to:
                        
                                    (1)
                                 
                                 
                                    an AeMC, AME or GMP for the purpose of completion of an aero-medical assessment;
                                 
                              
                                    (2)
                                 
                                 
                                    a medical review board that may be established by the competent authority for secondary review of borderline cases;
                                 
                              
                                    (3)
                                 
                                 
                                    relevant medical specialists for the purpose of completion of an aero-medical assessment;
                                 
                              
                                    (4)
                                 
                                 
                                    the medical assessor of the competent authority of another Member State for the purpose of cooperative oversight;
                                 
                              
                                    (5)
                                 
                                 
                                    the applicant/licence holder concerned upon their written request; and
                                 
                              
                                    (6)
                                 
                                 
                                    after disidentification of the applicant/licence holder to the Agency for standardisation purposes.
                                 
                              
                  
                        (d)
                     
                     
                        The competent authority may make aero-medical records available for other purposes than those mentioned in (c) in accordance with Directive 95/46/EC as implemented under national law.
                     
                  
                        (e)
                     
                     
                        The competent authority shall maintain lists:
                        
                                    (1)
                                 
                                 
                                    of all AMEs that hold a valid certificate issued by that authority; and
                                 
                              
                                    (2)
                                 
                                 
                                    where applicable, of all GMPs acting as AMEs on their territory.
                                 
                              These lists shall be disclosed to other Member States and the Agency upon request.
                     
                  
               SECTION II
            
            
               
                  Aero-medical examiners (AMEs)
               
            
            
               ARA.MED.200   Procedure for the issue, revalidation, renewal or change of an AME certificate
            
            
                        (a)
                     
                     
                        The certification procedure for an AME shall follow the provisions laid down in ARA.GEN.315. Before issuing the certificate, the competent authority shall have evidence that the AME practice is fully equipped to perform aero-medical examinations within the scope of the AME certificate applied for.
                     
                  
                        (b)
                     
                     
                        When satisfied that the AME is in compliance with the applicable requirements, the competent authority shall issue, revalidate, renew or change the AME certificate for a period of 3 years, using the form as established in Appendix VII to this Part.
                     
                  
               ARA.MED.240   General medical practitioners (GMPs) acting as AMEs
            
            The competent authority of a Member State shall notify the Agency and competent authorities of other Member States if aero-medical examinations for the LAPL can be carried out on its territory by GMPs.
            
               ARA.MED.245   Continuing oversight of AMEs and GMPs
            
            When developing the continuing oversight programme referred to in ARA.GEN.305, the competent authority shall take into account the number of AMEs and GMPs exercising their privileges within the territory where the competent authority exercises oversight.
            
               ARA.MED.250   Limitation, suspension or revocation of an AME certificate
            
            
                        (a)
                     
                     
                        The competent authority shall limit, suspend or revoke an AME certificate in cases where:
                        
                                    (1)
                                 
                                 
                                    the AME no longer complies with applicable requirements;
                                 
                              
                                    (2)
                                 
                                 
                                    failure to meet the criteria for certification or continuing certification;
                                 
                              
                                    (3)
                                 
                                 
                                    deficiency of aero-medical record-keeping or submission of incorrect data or information;
                                 
                              
                                    (4)
                                 
                                 
                                    falsification of medical records, certificates or documentation;
                                 
                              
                                    (5)
                                 
                                 
                                    concealment of facts appertaining to an application for, or holder of, a medical certificate or false or fraudulent statements or representations to the competent authority;
                                 
                              
                                    (6)
                                 
                                 
                                    failure to correct findings from audit of the AME practice; and
                                 
                              
                                    (7)
                                 
                                 
                                    at the request of the certified AME.
                                 
                              
                  
                        (b)
                     
                     
                        The certificate of an AME shall be automatically revoked in either of the following circumstances:
                        
                                    (1)
                                 
                                 
                                    revocation of medical licence to practice; or
                                 
                              
                                    (2)
                                 
                                 
                                    removal from the Medical Register.
                                 
                              
                  
               ARA.MED.255   Enforcement measures
            
            If, during oversight or by any other means, evidence is found showing a non-compliance of an AeMC, an AME or a GMP, the licensing authority shall have a process to review the medical certificates issued by that AeMC, AME or GMP and may render them invalid where required to ensure flight safety.
            
               SECTION III
            
            
               
                  Medical certification
               
            
            
               ARA.MED.315   Review of examination reports
            
            The licensing authority shall have a process in place to:
            
                        (a)
                     
                     
                        review examination and assessment reports received from the AeMCs, AMEs and GMPs and inform them of any inconsistencies, mistakes or errors made in the assessment process; and
                     
                  
                        (b)
                     
                     
                        assist AMEs and AeMCs on their request regarding their decision on aero-medical fitness in contentious cases.
                     
                  
               ARA.MED.325   Secondary review procedure
            
            The competent authority shall establish a procedure for the review of borderline and contentious cases with independent medical advisors, experienced in the practice of aviation medicine, to consider and advise on an applicant’s fitness for medical certification.
         
         
            Appendix I to ANNEX VI PART-ARA
            
               Flight crew licence
            
            The flight crew licence issued by a Member State in accordance with Part-FCL shall conform to the following specifications:
            
                        (a)
                     
                     
                        Content. The item number shown shall always be printed in association with the item heading. Items I to XI are the “permanent” items and items XII to XIV are the “variable” items which may appear on a separate or detachable part of the main form. Any separate or detachable part shall be clearly identifiable as part of the licence.
                        
                                    (1)
                                 
                                 
                                    Permanent items:
                                    
                                                (I)
                                             
                                             
                                                State of licence issue;
                                             
                                          
                                                (II)
                                             
                                             
                                                title of licence;
                                             
                                          
                                                (III)
                                             
                                             
                                                serial number of the licence commencing with the UN country code of the State of licence issue and followed by “FCL” and a code of numbers and/or letters in Arabic numerals and in latin script;
                                             
                                          
                                                (IV)
                                             
                                             
                                                name of holder (in latin script, even if the script of the national language(s) is other than latin);
                                             
                                          
                                                (IVa)
                                             
                                             
                                                date of birth;
                                             
                                          
                                                (V)
                                             
                                             
                                                holder’s address;
                                             
                                          
                                                (VI)
                                             
                                             
                                                nationality of holder;
                                             
                                          
                                                (VII)
                                             
                                             
                                                signature of holder;
                                             
                                          
                                                (VIII)
                                             
                                             
                                                competent authority and, where necessary, conditions under which the licence was issued;
                                             
                                          
                                                (IX)
                                             
                                             
                                                certification of validity and authorisation for the privileges granted;
                                             
                                          
                                                (X)
                                             
                                             
                                                signature of the officer issuing the licence and the date of issue; and
                                             
                                          
                                                (XI)
                                             
                                             
                                                seal or stamp of the competent authority.
                                             
                                          
                              
                                    (2)
                                 
                                 
                                    Variable items
                                    
                                                (XII)
                                             
                                             
                                                ratings and certificates: class, type, instructor certificates, etc., with dates of expiry. Radio telephony (R/T) privileges may appear on the licence form or on a separate certificate;
                                             
                                          
                                                (XIII)
                                             
                                             
                                                remarks: i.e. special endorsements relating to limitations and endorsements for privileges, including endorsements of language proficiency and ratings for Annex II aircraft when used for commercial air transportation; and
                                             
                                          
                                                (XIV)
                                             
                                             
                                                any other details required by the competent authority (e.g. place of birth/place of origin).
                                             
                                          
                              
                  
                        (b)
                     
                     
                        Material. The paper or other material used will prevent or readily show any alterations or erasures. Any entries or deletions to the form will be clearly authorised by the competent authority.
                     
                  
                        (c)
                     
                     
                        Language. Licences shall be written in the national language(s) and in English and such other languages as the competent authority deems appropriate.
                     
                  
               
            
               
            
               
         
         
            Appendix II to ANNEX VI PART-ARA
            
               Standard EASA format for cabin crew attestations
            
            Cabin crew attestations issued in accordance with Part-CC in a Member State shall conform to the following specifications:
            
               
            Instructions:
            
                        (a)
                     
                     
                        The cabin crew attestation shall include all items specified in EASA Form 142 in accordance with items 1–12 below.
                     
                  
                        (b)
                     
                     
                        Size shall be one-eighth A4 and the material used shall prevent or readily show any alterations or erasures.
                     
                  
                        (c)
                     
                     
                        The document shall be printed in English and such other languages as the competent authority deems appropriate.
                     
                  
                        (d)
                     
                     
                        The document shall be issued by the competent authority or by an organisation approved to issue cabin crew attestations. In that latter case reference to the approval by the competent authority of the Member State shall be stated.
                     
                  
                        (e)
                     
                     
                        The cabin crew attestation is recognised in all Member States and it is not necessary to exchange the document when working in another Member State.
                     
                  
                        Item 1
                     
                     
                        :
                     
                     
                        The title “CABIN CREW ATTESTATION” and the reference to Part-CC.
                     
                  
                        Item 2
                     
                     
                        :
                     
                     
                        Attestation reference number shall commence with the UN country code of the Member State followed by at least the two last numbers of the year of issue and an individual reference/number according to a code established by the competent authority (e.g. BE-08-xxxx).
                     
                  
                        Item 3
                     
                     
                        :
                     
                     
                        The Member State where the attestation is issued.
                     
                  
                        Item 4
                     
                     
                        :
                     
                     
                        The full name (surname and first name) stated in the official identity document of the holder.
                     
                  
                        Items 5 and 6
                     
                     
                        :
                     
                     
                        Date and place of birth as well as nationality as stated in the official identity document of the holder.
                     
                  
                        Item 7
                     
                     
                        :
                     
                     
                        The signature of the holder.
                     
                  
                        Item 8
                     
                     
                        :
                     
                     
                        Identification details of the competent authority of the Member State where the attestation is issued shall be entered and shall provide the full name of the competent authority, postal address, official seal, and logo if applicable.
                     
                  
                        Item 9
                     
                     
                        :
                     
                     
                        If the competent authority is the issuing body, the term “competent authority” and official seal or stamp shall be entered.
                        In the case of an approved organisation, identification details shall be entered and shall at least provide the full name of the organisation, postal address and if applicable, the logo and:
                        
                                    (a)
                                 
                                 
                                    in the case of a commercial air transport operator, the air operator certificate (AOC) number and detailed reference to the approvals by the competent authority to provide cabin crew training and to issue attestations; or
                                 
                              
                                    (b)
                                 
                                 
                                    in the case of an approved training organisation, the reference number of the relevant approval by the competent authority.
                                 
                              
                  
                        Item 10
                     
                     
                        :
                     
                     
                        The signature of the officer acting on behalf of the issuing body.
                     
                  
                        Item 11
                     
                     
                        :
                     
                     
                        Standard date format shall be used: i.e. day/month/year in full (e.g. 22/02/2008).
                     
                  
                        Item 12
                     
                     
                        :
                     
                     
                        The same sentence in English and its full and precise translation into such other languages as the competent authority deems appropriate.
                     
                  
         
            Appendix III to ANNEX VI PART-ARA
            
               
            
               
         
         
            Appendix IV to ANNEX VI PART-ARA
            
               FLIGHT SIMULATION TRAINING DEVICE QUALIFICATION CERTIFICATE
            
            
               Introduction
            
            EASA Form 145 shall be used for the FSTD qualification certificate. This document shall contain the FSTD Specification including any limitation(s) and special authorisation(s) or approval(s) as appropriate to the FSTD concerned. The qualification certificate shall be printed in English and in any other language(s) determined by the competent authority.
            Convertible FSTDs shall have a separate qualification certificate for each aircraft type. Different engine and equipment fit on one FSTD shall not require separate qualification certificates. All qualification certificates shall carry a serial number prefixed by a code in letters, which shall be specific to that FSTD. The letter code shall be specific to the competent authority of issue.
            
               
            
               
         
         
            Appendix V to ANNEX VI PART-ARA
            
               
         
         
            Appendix VI to ANNEX VI PART-ARA
            
               STANDARD EASA MEDICAL CERTIFICATE FORMAT
            
            The medical certificate shall conform to the following specifications:
            
                        (a)
                     
                     
                        Content
                        
                                    (1)
                                 
                                 
                                    State where the pilot licence has been issued or applied for (I),
                                 
                              
                                    (2)
                                 
                                 
                                    Class of medical certificate (II),
                                 
                              
                                    (3)
                                 
                                 
                                    Certificate number commencing with the UN country code of the State where the pilot licence has been issued or applied for and followed by a code of numbers and/or letters in Arabic numerals and latin script (III),
                                 
                              
                                    (4)
                                 
                                 
                                    Name of holder (IV),
                                 
                              
                                    (5)
                                 
                                 
                                    Nationality of holder (VI),
                                 
                              
                                    (6)
                                 
                                 
                                    Date of birth of holder: (dd/mm/yyyy) (XIV),
                                 
                              
                                    (7)
                                 
                                 
                                    Signature of holder (VII)
                                 
                              
                                    (8)
                                 
                                 
                                    Limitation(s) (XIII)
                                 
                              
                                    (9)
                                 
                                 
                                    Expiry date of the medical certificate (IX) for:
                                    
                                                 
                                             
                                             
                                                Class 1 single pilot commercial operations carrying passengers,
                                             
                                          
                                                 
                                             
                                             
                                                Class 1 other commercial operations,
                                             
                                          
                                                 
                                             
                                             
                                                Class 2,
                                             
                                          
                                                 
                                             
                                             
                                                LAPL
                                             
                                          
                              
                                    (10)
                                 
                                 
                                    Date of medical examination
                                 
                              
                                    (11)
                                 
                                 
                                    Date of last electrocardiogram
                                 
                              
                                    (12)
                                 
                                 
                                    Date of last audiogram
                                 
                              
                                    (13)
                                 
                                 
                                    Date of issue and signature of the AME or medical assessor that issued the certificate (X). GMP may be added to this field if they have the competence to issue medical certificates under the national law of the Member State where the licence is issued.
                                 
                              
                                    (14)
                                 
                                 
                                    Seal or stamp (XI)
                                 
                              
                  
                        (b)
                     
                     
                        Material: Except for the case of LAPL issued by a GMP the paper or other material used shall prevent or readily show any alterations or erasures. Any entries or deletions to the form shall be clearly authorised by the licensing authority.
                     
                  
                        (c)
                     
                     
                        Language: Licences shall be written in the national language(s) and in English and such other languages as the licensing authority deems appropriate.
                     
                  
                        (d)
                     
                     
                        All dates on the medical certificate shall be written in a dd/mm/yyyy format.
                     
                  
                        (e)
                     
                     
                        A standard medical certificate format is shown in this Appendix.
                     
                  
               
            
               
            
               
         
         
            Appendix VII to ANNEX VI PART-ARA
            
               
            
               
         
         
            ANNEX VII
            
               ORGANISATION REQUIREMENTS FOR AIRCREW
            
            
               [PART-ORA]
            
            SUBPART GEN
            
               
                  GENERAL REQUIREMENTS
               
            
            
               SECTION I
            
            
               
                  General
               
            
            
               ORA.GEN.105   Competent authority
            
            
                        (a)
                     
                     
                        For the purpose of this Part, the competent authority exercising oversight over:
                        
                                    (1)
                                 
                                 
                                    organisations subject to a certification obligation shall be:
                                    
                                                (i)
                                             
                                             
                                                for organisations having their principal place of business in a Member State, the authority designated by that Member State;
                                             
                                          
                                                (ii)
                                             
                                             
                                                for organisations having their principal place of business located in a third country, the Agency;
                                             
                                          
                              
                                    (2)
                                 
                                 
                                    FSTDs shall be:
                                    
                                                (i)
                                             
                                             
                                                the Agency, for FSTDs:
                                                
                                                            —
                                                         
                                                         
                                                            located outside the territory of the Member States, or,
                                                         
                                                      
                                                            —
                                                         
                                                         
                                                            located within the territory of the Member States and operated by organisations having their principal place of business located in a third country,
                                                         
                                                      
                                          
                                                (ii)
                                             
                                             
                                                for FSTDs located within the territory of the Member States and operated by organisations having their principal place of business in a Member State, the authority designated by the Member State where the organisation operating it has its principle place of business, or the Agency, if so requested by the Member State concerned.
                                             
                                          
                              
                  
                        (b)
                     
                     
                        When the FSTD located outside the territory of the Member States is operated by an organisation certified by a Member State, the Agency shall qualify this FSTD in coordination with the Member State that has certified the organisation that operates such FSTD.
                     
                  
               ORA.GEN.115   Application for an organisation certificate
            
            
                        (a)
                     
                     
                        The application for an organisation certificate or an amendment to an existing certificate shall be made in a form and manner established by the competent authority, taking into account the applicable requirements of Regulation (EC) No 216/2008 and its Implementing Rules.
                     
                  
                        (b)
                     
                     
                        Applicants for an initial certificate shall provide the competent authority with documentation demonstrating how they will comply with the requirements established in Regulation (EC) No 216/2008 and its Implementing Rules. Such documentation shall include a procedure describing how changes not requiring prior approval will be managed and notified to the competent authority.
                     
                  
               ORA.GEN.120   Means of compliance
            
            
                        (a)
                     
                     
                        Alternative means of compliance to the AMC adopted by the Agency may be used by an organisation to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules.
                     
                  
                        (b)
                     
                     
                        When an organisation wishes to use an alternative means of compliance, it shall, prior to implementing it, provide the competent authority with a full description of the alternative means of compliance. The description shall include any revisions to manuals or procedures that may be relevant, as well as an assessment demonstrating that Regulation (EC) No 216/2008 and its Implementing Rules are met.
                        The organisation may implement these alternative means of compliance subject to prior approval by the competent authority and upon receipt of the notification as prescribed in ARA.GEN.120(d).
                     
                  
               ORA.GEN.125   Terms of approval and privileges of an organisation
            
            A certified organisation shall comply with the scope and privileges defined in the terms of approval attached to the organisation’s certificate.
            
               ORA.GEN.130   Changes to organisations
            
            
                        (a)
                     
                     
                        Any change affecting:
                        
                                    (1)
                                 
                                 
                                    the scope of the certificate or the terms of approval of an organisation; or
                                 
                              
                                    (2)
                                 
                                 
                                    any of the elements of the organisation’s management system as required in ORA.GEN.200(a)(1) and (a)(2),
                                 
                              shall require prior approval by the competent authority.
                     
                  
                        (b)
                     
                     
                        For any changes requiring prior approval in accordance with Regulation (EC) No 216/2008 and its Implementing Rules, the organisation shall apply for and obtain an approval issued by the competent authority. The application shall be submitted before any such change takes place, in order to enable the competent authority to determine continued compliance with Regulation (EC) No 216/2008 and its Implementing Rules and to amend, if necessary, the organisation certificate and related terms of approval attached to it.
                        The organisation shall provide the competent authority with any relevant documentation.
                        The change shall only be implemented upon receipt of formal approval by the competent authority in accordance with ARA.GEN.330.
                        The organisation shall operate under the conditions prescribed by the competent authority during such changes, as applicable.
                     
                  
                        (c)
                     
                     
                        All changes not requiring prior approval shall be managed and notified to the competent authority as defined in the procedure approved by the competent authority in accordance with ARA.GEN.310(c).
                     
                  
               ORA.GEN.135   Continued validity
            
            
                        (a)
                     
                     
                        The organisation’s certificate shall remain valid subject to:
                        
                                    (1)
                                 
                                 
                                    the organisation remaining in compliance with the relevant requirements of Regulation (EC) No 216/2008 and its Implementing Rules, taking into account the provisions related to the handling of findings as specified under ORA.GEN.150;
                                 
                              
                                    (2)
                                 
                                 
                                    the competent authority being granted access to the organisation as defined in ORA.GEN.140 to determine continued compliance with the relevant requirements of Regulation (EC) No 216/2008 and its Implementing Rules; and
                                 
                              
                                    (3)
                                 
                                 
                                    the certificate not being surrendered or revoked.
                                 
                              
                  
                        (b)
                     
                     
                        Upon revocation or surrender the certificate shall be returned to the competent authority without delay.
                     
                  
               ORA.GEN.140   Access
            
            For the purpose of determining compliance with the relevant requirements of Regulation (EC) No 216/2008 and its Implementing Rules, the organisation shall grant access to any facility, aircraft, document, records, data, procedures or any other material relevant to its activity subject to certification, whether it is contracted or not, to any person authorised by:
            
                        (a)
                     
                     
                        the competent authority defined in ORA.GEN.105; or
                     
                  
                        (b)
                     
                     
                        the authority acting under the provisions of ARA.GEN.300(d), ARA.GEN.300(e) or ARO.RAMP.
                     
                  
               ORA.GEN.150   Findings
            
            After receipt of notification of findings, the organisation shall:
            
                        (a)
                     
                     
                        identify the root cause of the non-compliance;
                     
                  
                        (b)
                     
                     
                        define a corrective action plan; and
                     
                  
                        (c)
                     
                     
                        demonstrate corrective action implementation to the satisfaction of the competent authority within a period agreed with that authority as defined in ARA.GEN.350(d).
                     
                  
               ORA.GEN.155   Immediate reaction to a safety problem
            
            The organisation shall implement:
            
                        (a)
                     
                     
                        any safety measures mandated by the competent authority in accordance with ARA.GEN.135(c); and
                     
                  
                        (b)
                     
                     
                        any relevant mandatory safety information issued by the Agency, including airworthiness directives.
                     
                  
               ORA.GEN.160   Occurrence reporting
            
            
                        (a)
                     
                     
                        The organisation shall report to the competent authority, and to any other organisation required by the State of the operator to be informed, any accident, serious incident and occurrence as defined in Regulation (EU) No 996/2010 of the European Parliament and of the Council (2) and Directive 2003/42/EC of the European Parliament and of the Council (3).
                     
                  
                        (b)
                     
                     
                        Without prejudice to paragraph (a) the organisation shall report to the competent authority and to the organisation responsible for the design of the aircraft any incident, malfunction, technical defect, exceeding of technical limitations, occurrence that would highlight inaccurate, incomplete or ambiguous information contained in data established in accordance with Part-21 or other irregular circumstance that has or may have endangered the safe operation of the aircraft and that has not resulted in an accident or serious incident.
                     
                  
                        (c)
                     
                     
                        Without prejudice to Regulation (EU) No 996/2010, Directive 2003/42/EC, Commission Regulation (EC) No 1321/2007 (4) and Commission Regulation (EC) No 1330/2007 (5), the reports referred in paragraphs (a) and (b) shall be made in a form and manner established by the competent authority and contain all pertinent information about the condition known to the organisation.
                     
                  
                        (d)
                     
                     
                        Reports shall be made as soon as practicable, but in any case within 72 hours of the organisation identifying the condition to which the report relates, unless exceptional circumstances prevent this.
                     
                  
                        (e)
                     
                     
                        Where relevant, the organisation shall produce a follow-up report to provide details of actions it intends to take to prevent similar occurrences in the future, as soon as these actions have been identified. This report shall be produced in a form and manner established by the competent authority.
                     
                  
               SECTION II
            
            
               
                  Management
               
            
            
               ORA.GEN.200   Management system
            
            
                        (a)
                     
                     
                        The organisation shall establish, implement and maintain a management system that includes:
                        
                                    (1)
                                 
                                 
                                    clearly defined lines of responsibility and accountability throughout the organisation, including a direct safety accountability of the accountable manager;
                                 
                              
                                    (2)
                                 
                                 
                                    a description of the overall philosophies and principles of the organisation with regard to safety, referred to as the safety policy;
                                 
                              
                                    (3)
                                 
                                 
                                    the identification of aviation safety hazards entailed by the activities of the organisation, their evaluation and the management of associated risks, including taking actions to mitigate the risk and verify their effectiveness;
                                 
                              
                                    (4)
                                 
                                 
                                    maintaining personnel trained and competent to perform their tasks;
                                 
                              
                                    (5)
                                 
                                 
                                    documentation of all management system key processes, including a process for making personnel aware of their responsibilities and the procedure for amending this documentation;
                                 
                              
                                    (6)
                                 
                                 
                                    a function to monitor compliance of the organisation with the relevant requirements. Compliance monitoring shall include a feedback system of findings to the accountable manager to ensure effective implementation of corrective actions as necessary; and
                                 
                              
                                    (7)
                                 
                                 
                                    any additional requirements that are prescribed in the relevant subparts of this Part or other applicable Parts.
                                 
                              
                  
                        (b)
                     
                     
                        The management system shall correspond to the size of the organisation and the nature and complexity of its activities, taking into account the hazards and associated risks inherent in these activities.
                     
                  
               ORA.GEN.205   Contracted activities
            
            
                        (a)
                     
                     
                        Contracted activities include all activities within the organisation’s scope of approval that are performed by another organisation either itself certified to carry out such activity or if not certified, working under the contracting organisation’s approval. The organisation shall ensure that when contracting or purchasing any part of its activity, the contracted or purchased service or product conforms to the applicable requirements.
                     
                  
                        (b)
                     
                     
                        When the certified organisation contracts any part of its activity to an organisation that is not itself certified in accordance with this Part to carry out such activity, the contracted organisation shall work under the approval of the contracting organisation. The contracting organisation shall ensure that the competent authority is given access to the contracted organisation, to determine continued compliance with the applicable requirements.
                     
                  
               ORA.GEN.210   Personnel requirements
            
            
                        (a)
                     
                     
                        The organisation shall appoint an accountable manager, who has the authority for ensuring that all activities can be financed and carried out in accordance with the applicable requirements. The accountable manager shall be responsible for establishing and maintaining an effective management system.
                     
                  
                        (b)
                     
                     
                        A person or group of persons shall be nominated by the organisation, with the responsibility of ensuring that the organisation remains in compliance with the applicable requirements. Such person(s) shall be ultimately responsible to the accountable manager.
                     
                  
                        (c)
                     
                     
                        The organisation shall have sufficient qualified personnel for the planned tasks and activities to be performed in accordance with the applicable requirements.
                     
                  
                        (d)
                     
                     
                        The organisation shall maintain appropriate experience, qualification and training records to show compliance with paragraph (c).
                     
                  
                        (e)
                     
                     
                        The organisation shall ensure that all personnel are aware of the rules and procedures relevant to the exercise of their duties.
                     
                  
               ORA.GEN.215   Facility requirements
            
            The organisation shall have facilities allowing the performance and management of all planned tasks and activities in accordance with the applicable requirements.
            
               ORA.GEN.220   Record-keeping
            
            
                        (a)
                     
                     
                        The organisation shall establish a system of record–keeping that allows adequate storage and reliable traceability of all activities developed, covering in particular all the elements indicated in ORA.GEN.200.
                     
                  
                        (b)
                     
                     
                        The format of the records shall be specified in the organisation’s procedures.
                     
                  
                        (c)
                     
                     
                        Records shall be stored in a manner that ensures protection from damage, alteration and theft.
                     
                  SUBPART ATO
            
               
                  APPROVED TRAINING ORGANISATIONS
               
            
            
               SECTION I
            
            
               
                  General
               
            
            
               ORA.ATO.100   Scope
            
            This Subpart establishes the requirements to be met by organisations providing training for pilot licences and associated ratings and certificates.
            
               ORA.ATO.105   Application
            
            
                        (a)
                     
                     
                        Applicants for the issue of a certificate as an approved training organisation (ATO) shall provide the competent authority with:
                        
                                    (1)
                                 
                                 
                                    the following information:
                                    
                                                (i)
                                             
                                             
                                                name and address of the training organisation;
                                             
                                          
                                                (ii)
                                             
                                             
                                                date of intended commencement of activity;
                                             
                                          
                                                (iii)
                                             
                                             
                                                personal details and qualifications of the head of training (HT), the flight instructor(s), flight simulation training instructors and the theoretical knowledge instructor(s);
                                             
                                          
                                                (iv)
                                             
                                             
                                                name(s) and address(es) of the aerodromes(s) and/or operating site(s) at which the training is to be conducted;
                                             
                                          
                                                (v)
                                             
                                             
                                                list of aircraft to be operated for training, including their group, class or type, registration, owners and category of the certificate of airworthiness, if applicable
                                             
                                          
                                                (vi)
                                             
                                             
                                                list of flight simulation training devices (FSTDs) that the training organisation intends to use, if applicable;
                                             
                                          
                                                (vii)
                                             
                                             
                                                the type of training that the training organisation wishes to provide and the corresponding training programme; and
                                             
                                          
                              
                                    (2)
                                 
                                 
                                    the operations and training manuals.
                                 
                              
                  
                        (b)
                     
                     
                        Flight test training organisations. Notwithstanding (a)(1)(iv) and (v), training organisations providing flight test training shall only need to provide:
                        
                                    (1)
                                 
                                 
                                    the name(s) and address(es) of the main aerodromes and/or operating site(s) at which the training is to be conducted; and
                                 
                              
                                    (2)
                                 
                                 
                                    a list of the types or categories of aircraft to be used for flight test training.
                                 
                              
                  
                        (c)
                     
                     
                        In the case of a change to the certificate, applicants shall provide the competent authority with the relevant parts of the information and documentation referred to in (a).
                     
                  
               ORA.ATO.110   Personnel requirements
            
            
                        (a)
                     
                     
                        An HT shall be nominated. The HT shall have extensive experience as an instructor in the areas relevant for the training provided by the ATO and shall possess sound managerial capability.
                     
                  
                        (b)
                     
                     
                        The HT’s responsibilities shall include:
                        
                                    (1)
                                 
                                 
                                    ensuring that the training provided is in compliance with Part-FCL and, in the case of flight test training, that the relevant requirements of Part-21 and the training programme have been established;
                                 
                              
                                    (2)
                                 
                                 
                                    ensuring the satisfactory integration of flight training in an aircraft or a flight simulation training device (FSTD) and theoretical knowledge instruction; and
                                 
                              
                                    (3)
                                 
                                 
                                    supervising the progress of individual students.
                                 
                              
                  
                        (c)
                     
                     
                        Theoretical knowledge instructors shall have:
                        
                                    (1)
                                 
                                 
                                    practical background in aviation in the areas relevant for the training provided and have undergone a course of training in instructional techniques; or
                                 
                              
                                    (2)
                                 
                                 
                                    previous experience in giving theoretical knowledge instruction and an appropriate theoretical background in the subject on which they will provide theoretical knowledge instruction.
                                 
                              
                  
                        (d)
                     
                     
                        Flight instructors and flight simulation training instructors shall hold the qualifications required by Part-FCL for the type of training that they are providing.
                     
                  
               ORA.ATO.120   Record-keeping
            
            The following records shall be kept for a period of at least 3 years after the completion of the training:
            
                        (a)
                     
                     
                        details of ground, flight, and simulated flight training given to individual students;
                     
                  
                        (b)
                     
                     
                        detailed and regular progress reports from instructors including assessments, and regular progress flight tests and ground examinations; and
                     
                  
                        (c)
                     
                     
                        information on the licences and associated ratings and certificates of the students, including the expiry dates of medical certificates and ratings.
                     
                  
               ORA.ATO.125   Training programme
            
            
                        (a)
                     
                     
                        A training programme shall be developed for each type of course offered.
                     
                  
                        (b)
                     
                     
                        The training programme shall comply with the requirements of Part-FCL and, in the case of flight test training, the relevant requirements of Part-21.
                     
                  
               ORA.ATO.130   Training manual and operations manual
            
            
                        (a)
                     
                     
                        The ATO shall establish and maintain a training manual and operations manual containing information and instructions to enable personnel to perform their duties and to give guidance to students on how to comply with course requirements.
                     
                  
                        (b)
                     
                     
                        The ATO shall make available to staff and, where appropriate, to students the information contained in the training manual, the operations manual and the ATO’s approval documentation.
                     
                  
                        (c)
                     
                     
                        In the case of ATOs providing flight test training, the operations manual shall comply with the requirements for the flight test operations manual, as established in Part-21.
                     
                  
                        (d)
                     
                     
                        The operations manual shall establish flight time limitation schemes for flight instructors, including the maximum flying hours, maximum flying duty hours and minimum rest time between instructional duties in accordance with Part-ORO.
                     
                  
               ORA.ATO.135   Training aircraft and FSTDs
            
            
                        (a)
                     
                     
                        The ATO shall use an adequate fleet of training aircraft or FSTDs appropriate to the courses of training provided.
                     
                  
                        (b)
                     
                     
                        The ATO shall only provide training in FSTDs when it demonstrates to the competent authority:
                        
                                    (1)
                                 
                                 
                                    the adequacy between the FSTD specifications and the related training programme;
                                 
                              
                                    (2)
                                 
                                 
                                    that the FSTDs used comply with the relevant requirements of Part-FCL;
                                 
                              
                                    (3)
                                 
                                 
                                    in the case of full flight simulators (FFSs), that the FFS adequately represents the relevant type of aircraft; and
                                 
                              
                                    (4)
                                 
                                 
                                    that it has put in place a system to adequately monitor changes to the FSTD and to ensure that those changes do not affect the adequacy of the training programme.
                                 
                              
                  
                        (c)
                     
                     
                        If the aircraft used for the skill test is of a different type to the FFS used for the visual flight training, the maximum credit shall be limited to that allocated for flight and navigation procedures trainer II (FNPT II) for aeroplanes and FNPT II/III for helicopters in the relevant flight training programme.
                     
                  
                        (d)
                     
                     
                        Flight test training organisations. Aircraft used for flight test training shall be appropriately equipped with flight testing instrumentation, according to the purpose of the training.
                     
                  
               ORA.ATO.140   Aerodromes and operating sites
            
            When providing flight training on an aircraft, the ATO shall use aerodromes or operating sites that have the appropriate facilities and characteristics to allow training of the manoeuvres relevant, taking into account the training provided and the category and type of aircraft used.
            
               ORA.ATO.145   Pre-requisites for training
            
            
                        (a)
                     
                     
                        The ATO shall ensure that the students meet all the pre-requisites for training established in Part-Medical, Part-FCL, and, if applicable, as defined in the data established in accordance with Part-21.
                     
                  
                        (b)
                     
                     
                        In the case of ATOs providing flight test training, the students shall meet all the pre-requisites for training established in Part-21.
                     
                  
               ORA.ATO.150   Training in third countries
            
            When the ATO is approved to provide training for the instrument rating (IR) in third countries:
            
                        (a)
                     
                     
                        the training programme shall include acclimatisation flying in one of the Member States before the IR skill test is taken; and
                     
                  
                        (b)
                     
                     
                        the IR skill test shall be taken in one of the Member States.
                     
                  
               SECTION II
            
            
               
                  Additional requirements for ATOs providing training for CPL, MPL and ATPL and the associated ratings and certificates
               
            
            
               ORA.ATO.210   Personnel requirements
            
            
                        (a)
                     
                     
                        
                           Head of training (HT). Except in the case of ATOs providing flight test training, the nominated HT shall have extensive experience in training as an instructor for professional pilot licences and associated ratings or certificates.
                     
                  
                        (b)
                     
                     
                        
                           Chief flight instructor (CFI). The ATO providing flight instruction shall nominate a CFI who shall be responsible for the supervision of flight and flight simulation training instructors and for the standardisation of all flight instruction and flight simulation instruction. The CFI shall hold the highest professional pilot licence and associated ratings related to the flight training courses conducted and hold an instructor certificate with the privilege to instruct for at least one of the training courses provided.
                     
                  
                        (c)
                     
                     
                        
                           Chief theoretical knowledge instructor (CTKI). The ATO providing theoretical knowledge instruction shall nominate a CTKI who shall be responsible for the supervision of all theoretical knowledge instructors and for the standardisation of all theoretical knowledge instruction. The CTKI shall have extensive experience as a theoretical knowledge instructor in the areas relevant for the training provided by the ATO.
                     
                  
               ORA.ATO.225   Training programme
            
            
                        (a)
                     
                     
                        The training programme shall include a breakdown of flight and theoretical knowledge instruction, presented in a week-by-week or phase layout, a list of standard exercises and a syllabus summary.
                     
                  
                        (b)
                     
                     
                        The content and sequence of the training programme shall be specified in the training manual.
                     
                  
               ORA.ATO.230   Training manual and operations manual
            
            
                        (a)
                     
                     
                        The training manual shall state the standards, objectives and training goals for each phase of training that the students are required to comply with and shall address the following subjects:
                        
                                    —
                                 
                                 
                                    training plan,
                                 
                              
                                    —
                                 
                                 
                                    briefing and air exercises,
                                 
                              
                                    —
                                 
                                 
                                    flight training in an FSTD, if applicable,
                                 
                              
                                    —
                                 
                                 
                                    theoretical knowledge instruction.
                                 
                              
                  
                        (b)
                     
                     
                        The operations manual shall provide relevant information to particular groups of personnel, as flight instructors, flight simulation training instructors, theoretical knowledge instructors, operations and maintenance personnel, and shall include general, technical, route and staff training information.
                     
                  
               SECTION III
            
            
               
                  Additional requirements for atos providing specific types of training
               
            
            
               Chapter 1
            
            
               
                  Distance Learning Course
               
            
            
               ORA.ATO.300   General
            
            The ATO may be approved to conduct modular course programmes using distance learning in the following cases:
            
                        (a)
                     
                     
                        modular courses of theoretical knowledge instruction;
                     
                  
                        (b)
                     
                     
                        courses of additional theoretical knowledge for a class or type rating; or
                     
                  
                        (c)
                     
                     
                        courses of approved pre-entry theoretical knowledge instruction for a first type rating for a multi-engined helicopter.
                     
                  
               ORA.ATO.305   Classroom instruction
            
            
                        (a)
                     
                     
                        An element of classroom instruction shall be included in all subjects of modular distance learning courses.
                     
                  
                        (b)
                     
                     
                        The amount of time spent in actual classroom instruction shall not be less than 10 % of the total duration of the course.
                     
                  
                        (c)
                     
                     
                        To this effect, classroom accommodation shall be available either at the principal place of business of the ATO or within a suitable facility elsewhere.
                     
                  
               ORA.ATO.310   Instructors
            
            All instructors shall be fully familiar with the requirements of the distance learning course programme.
            
               Chapter 2
            
            
               
                  Zero Flight-Time Training
               
            
            
               ORA.ATO.330   General
            
            
                        (a)
                     
                     
                        Approval for zero flight-time training (ZFTT), as specified in Part-FCL, shall only be given to ATOs that also have the privileges to conduct commercial air transport operations or ATOs having specific arrangements with commercial air transport operators.
                     
                  
                        (b)
                     
                     
                        Approval for ZFTT shall only be given if the operator has at least 90 days of operational experience on the aeroplane type.
                     
                  
                        (c)
                     
                     
                        In the case of ZFTT provided by an ATO having a specific arrangement with an operator, the 90 days of operational experience requirements will not apply if the type rating instructor (TRI(A)) involved in the additional take-offs and landings, as required in Part-ORO, has operational experience on the aeroplane type.
                     
                  
               ORA.ATO.335   Full flight simulator
            
            
                        (a)
                     
                     
                        The FFS approved for ZFTT shall be serviceable according to the management system criteria of the ATO.
                     
                  
                        (b)
                     
                     
                        The motion and the visual system of the FFS shall be fully serviceable, in accordance with the applicable certification specifications for FSTD as mentioned in ORA.FSTD.205.
                     
                  
               Chapter 3
            
            
               
                  Multi-crew pilot licence (MPL) courses
               
            
            
               ORA.ATO.350   General
            
            The privileges to conduct MPL integrated training courses and MPL instructor courses shall only be given to the ATO if it also has the privilege to conduct commercial air transport operations or a specific arrangement with a commercial air transport operator.
            
               Chapter 4
            
            
               
                  Flight test training
               
            
            
               ORA.ATO.355   Flight test training organisations
            
            
                        (a)
                     
                     
                        The ATO that has been approved to provide flight test training for the issue of a category 1 or 2 flight test rating in accordance with Part-FCL may have its privileges extended to providing training for other categories of flight tests and other categories of flight test personnel, provided that:
                        
                                    (1)
                                 
                                 
                                    the relevant requirements of Part-21 are met; and
                                 
                              
                                    (2)
                                 
                                 
                                    a specific arrangement exists between the ATO and the Part-21 organisation that employs, or intends to employ, such personnel.
                                 
                              
                  
                        (b)
                     
                     
                        The training records shall include the written reports by the student, as required by the training programme, including, where applicable, data processing and analysis of recorded parameters relevant to the type of flight test.
                     
                  SUBPART FSTD
            
               
                  REQUIREMENTS FOR ORGANISATIONS OPERATING FLIGHT SIMULATION TRAINING DEVICES (FSTDs) AND THE QUALIFICATION OF FSTDs
               
            
            
               SECTION I
            
            
               
                  Requirements for organisations operating FSTDs
               
            
            
               ORA.FSTD.100   General
            
            
                        (a)
                     
                     
                        The applicant for an FSTD qualification certificate shall demonstrate to the competent authority that it has established a management system in accordance with ORA.GEN Section II. This demonstration shall ensure that the applicant has, directly or through contract, the capability to maintain the performance, functions and other characteristics specified for the FSTD’s qualification level and to control the installation of the FSTD.
                     
                  
                        (b)
                     
                     
                        If the applicant is the holder of a qualification certificate issued in accordance with this Part, the FSTD specifications shall be detailed:
                        
                                    (1)
                                 
                                 
                                    in the terms of the ATO certificate; or
                                 
                              
                                    (2)
                                 
                                 
                                    in the case of an AOC holder, in the training manual.
                                 
                              
                  
               ORA.FSTD.105   Maintaining the FSTD qualification
            
            
                        (a)
                     
                     
                        In order to maintain the qualification of the FSTD, an FSTD qualification certificate holder shall run the complete set of tests contained within the master qualification test guide (MQTG) and functions and subjective tests progressively over a 12-month period.
                     
                  
                        (b)
                     
                     
                        The results shall be dated, marked as analysed and evaluated, and retained in accordance with ORA.FSTD.240, in order to demonstrate that the FSTD standards are being maintained.
                     
                  
                        (c)
                     
                     
                        A configuration control system shall be established to ensure the continued integrity of the hardware and software of the qualified FSTD.
                     
                  
               ORA.FSTD.110   Modifications
            
            
                        (a)
                     
                     
                        The holder of an FSTD qualification certificate shall establish and maintain a system to identify, assess and incorporate any important modifications into the FSTDs it operates, especially:
                        
                                    (1)
                                 
                                 
                                    any aircraft modifications that are essential for training, testing and checking, whether or not enforced by an airworthiness directive; and
                                 
                              
                                    (2)
                                 
                                 
                                    any modification of an FSTD, including motion and visual systems, when essential for training, testing and checking, as in the case of data revisions.
                                 
                              
                  
                        (b)
                     
                     
                        Modifications of the FSTD hardware and software that affect handling, performance and systems operation or any major modifications of the motion or visual system shall be evaluated to determine the impact on the original qualification criteria. The organisation shall prepare amendments for any affected validation tests. The organisation shall test the FSTD to the new criteria.
                     
                  
                        (c)
                     
                     
                        The organisation shall inform the competent authority in advance of any major changes to determine if the tests carried out are satisfactory. The competent authority shall determine if a special evaluation of the FSTD is necessary prior to returning it to training following the modification.
                     
                  
               ORA.FSTD.115   Installations
            
            
                        (a)
                     
                     
                        The holder of an FSTD qualification certificate shall ensure that:
                        
                                    (1)
                                 
                                 
                                    the FSTD is housed in a suitable environment that supports safe and reliable operation;
                                 
                              
                                    (2)
                                 
                                 
                                    all FSTD occupants and maintenance personnel are briefed on FSTD safety to ensure that they are aware of all safety equipment and procedures in the FSTD in case of an emergency; and
                                 
                              
                                    (3)
                                 
                                 
                                    the FSTD and its installations comply with the local regulations for health and safety.
                                 
                              
                  
                        (b)
                     
                     
                        The FSTD safety features, such as emergency stops and emergency lighting, shall be checked at least annually and recorded.
                     
                  
               ORA.FSTD.120   Additional equipment
            
            Where additional equipment has been added to the FSTD, even though not required for qualification, it shall be assessed by the competent authority to ensure that it does not adversely affect the quality of training.
            
               SECTION II
            
            
               
                  Requirements for the qualification of FSTDs
               
            
            
               ORA.FSTD.200   Application for FSTD qualification
            
            
                        (a)
                     
                     
                        The application for an FSTD qualification certificate shall be made in a form and manner established by the competent authority:
                        
                                    (1)
                                 
                                 
                                    in the case of basic instrument training devices (BITDs), by the BITD manufacturer;
                                 
                              
                                    (2)
                                 
                                 
                                    in all other cases, by the organisation intending to operate the FSTD.
                                 
                              
                  
                        (b)
                     
                     
                        Applicants for an initial qualification shall provide the competent authority with documentation demonstrating how they will comply with the requirements established in this Regulation. Such documentation shall include the procedure established to ensure compliance with ORA.GEN.130 and ORA.FSTD.230.
                     
                  
               ORA.FSTD.205   Certification specifications for FSTDs
            
            
                        (a)
                     
                     
                        The Agency shall issue, in accordance with Article 19 of Regulation (EC) No 216/2008, Certification Specifications as standard means to show compliance of FSTDs with the Essential Requirements of Annex III to Regulation (EC) No 216/2008.
                     
                  
                        (b)
                     
                     
                        Such Certification Specifications shall be sufficiently detailed and specific to indicate to applicants the conditions under which qualifications will be issued.
                     
                  
               ORA.FSTD.210   Qualification basis
            
            
                        (a)
                     
                     
                        The qualification basis for the issuance of an FSTD qualification certificate shall consist of:
                        
                                    (1)
                                 
                                 
                                    the applicable Certification Specifications established by the Agency that are effective on the date of the application for the initial qualification;
                                 
                              
                                    (2)
                                 
                                 
                                    the aircraft validation data defined by the data as approved under Part-21, if applicable; and
                                 
                              
                                    (3)
                                 
                                 
                                    any special conditions prescribed by the competent authority if the related Certification Specifications do not contain adequate or appropriate standards for the FSTD because the FSTD has novel or different features to those upon which the applicable Certification Specifications are based.
                                 
                              
                  
                        (b)
                     
                     
                        The qualification basis shall be applicable for future recurrent qualifications of the FSTD, unless it is recategorised.
                     
                  
               ORA.FSTD.225   Duration and continued validity
            
            
                        (a)
                     
                     
                        The full flight simulator (FFS), flight training device (FTD) or flight and navigation procedures trainer (FNPT) qualification shall remain valid subject to:
                        
                                    (1)
                                 
                                 
                                    the FSTD and the operating organisation remaining in compliance with the applicable requirements;
                                 
                              
                                    (2)
                                 
                                 
                                    the competent authority being granted access to the organisation as defined in ORA.GEN.140 to determine continued compliance with the relevant requirements of Regulation (EC) No 216/2008 and its Implementing Rules; and
                                 
                              
                                    (3)
                                 
                                 
                                    the qualification certificate not being surrendered or revoked.
                                 
                              
                  
                        (b)
                     
                     
                        The period of 12 months established in ARA.FSTD.120(b)(1) may be extended up to a maximum of 36 months, in the following circumstances:
                        
                                    (1)
                                 
                                 
                                    the FSTD has been subject to an initial and at least one recurrent evaluation that has established its compliance with the qualification basis;
                                 
                              
                                    (2)
                                 
                                 
                                    the FSTD qualification certificate holder has a satisfactory record of successful regulatory FSTD evaluations during the previous 36 months;
                                 
                              
                                    (3)
                                 
                                 
                                    the competent authority performs a formal audit of the compliance monitoring system defined in ORA.GEN.200(a)(6) of the organisation every 12 months; and
                                 
                              
                                    (4)
                                 
                                 
                                    an assigned person of the organisation with adequate experience reviews the regular reruns of the qualification test guide (QTG) and conducts the relevant functions and subjective tests every 12 months and sends a report of the results to the competent authority.
                                 
                              
                  
                        (c)
                     
                     
                        A BITD qualification shall remain valid subject to regular evaluation for compliance with the applicable qualification basis by the competent authority in accordance with ARA.FSTD.120.
                     
                  
                        (d)
                     
                     
                        Upon surrender or revocation, the FSTD qualification certificate shall be returned to the competent authority.
                     
                  
               ORA.FSTD.230   Changes to the qualified FSTD
            
            
                        (a)
                     
                     
                        The holder of an FSTD qualification certificate shall inform the competent authority of any proposed changes to the FSTD, such as:
                        
                                    (1)
                                 
                                 
                                    major modifications;
                                 
                              
                                    (2)
                                 
                                 
                                    relocation of the FSTD; and
                                 
                              
                                    (3)
                                 
                                 
                                    any de-activation of the FSTD.
                                 
                              
                  
                        (b)
                     
                     
                        In case of an upgrade of the FSTD qualification level, the organisation shall apply to the competent authority for an upgrade evaluation. The organisation shall run all validation tests for the requested qualification level. Results from previous evaluations shall not be used to validate FSTD performance for the current upgrade.
                     
                  
                        (c)
                     
                     
                        When an FSTD is moved to a new location, the organisation shall inform the competent authority before the planned activity along with a schedule of related events.
                        Prior to returning the FSTD to service at the new location, the organisation shall perform at least one third of the validation tests, and functions and subjective tests to ensure that the FSTD performance meets its original qualification standard. A copy of the test documentation shall be retained together with the FSTD records for review by the competent authority.
                        The competent authority may perform an evaluation of the FSTD after relocation. The evaluation shall be in accordance with the original qualification basis of the FSTD.
                     
                  
                        (d)
                     
                     
                        If an organisation plans to remove an FSTD from active status for prolonged periods, the competent authority shall be notified and suitable controls established for the period during which the FSTD is inactive.
                        The organisation shall agree with the competent authority a plan for the de-activation, any storage and re-activation to ensure that the FSTD can be restored to active status at its original qualification level.
                     
                  
               ORA.FSTD.235   Transferability of an FSTD qualification
            
            
                        (a)
                     
                     
                        When there is a change of the organisation operating an FSTD, the new organisation shall inform the competent authority in advance in order to agree upon a plan of transfer of the FSTD.
                     
                  
                        (b)
                     
                     
                        The competent authority may perform an evaluation in accordance with the original qualification basis of the FSTD.
                     
                  
                        (c)
                     
                     
                        When the FSTD no longer complies with its initial qualification basis, the organisation shall apply for a new FSTD qualification certificate.
                     
                  
               ORA.FSTD.240   Record-keeping
            
            The holder of an FSTD qualification certificate shall keep records of:
            
                        (a)
                     
                     
                        all documents describing and proving the initial qualification basis and level of the FSTD for the duration of the FSTD’s lifetime; and
                     
                  
                        (b)
                     
                     
                        any recurrent documents and reports related to each FSTD and to compliance monitoring activities for a period of at least 5 years.
                     
                  SUBPART AeMC
            
               
                  AERO-MEDICAL CENTRES
               
            
            
               SECTION I
            
            
               
                  General
               
            
            
               ORA.AeMC.105   Scope
            
            This Subpart establishes the additional requirements to be met by an organisation to qualify for the issue or continuation of an approval as an aero-medical centre (AeMC) to issue medical certificates, including initial class 1 medical certificates.
            
               ORA.AeMC.115   Application
            
            Applicants for an AeMC certificate shall:
            
                        (a)
                     
                     
                        comply with MED.D.005; and
                     
                  
                        (b)
                     
                     
                        in addition to the documentation for the approval of an organisation required in ORA.GEN.115, provide details of clinical attachments to or liaison with designated hospitals or medical institutes for the purpose of specialist medical examinations.
                     
                  
               ORA.AeMC.135   Continued validity
            
            The AeMC certificate shall be issued for an unlimited duration. It shall remain valid subject to the holder and the aero-medical examiners of the organisation:
            
                        (a)
                     
                     
                        complying with MED.D.030;and
                     
                  
                        (b)
                     
                     
                        ensuring their continued experience by performing an adequate number of class 1 medical examinations every year.
                     
                  
               SECTION II
            
            
               
                  Management
               
            
            
               ORA.AeMC.200   Management system
            
            The AeMC shall establish and maintain a management system that includes the items addressed in ORA.GEN.200 and, in addition, processes:
            
                        (a)
                     
                     
                        for medical certification in compliance with Part-MED; and
                     
                  
                        (b)
                     
                     
                        to ensure medical confidentiality at all times.
                     
                  
               ORA.AeMC.210   Personnel requirements
            
            
                        (a)
                     
                     
                        The AeMC shall:
                        
                                    (1)
                                 
                                 
                                    have an aero-medical examiner (AME) nominated as head of the AeMC, with privileges to issue class 1 medical certificates and sufficient experience in aviation medicine to exercise his/her duties; and
                                 
                              
                                    (2)
                                 
                                 
                                    have on staff an adequate number of fully qualified AMEs and other technical staff and experts.
                                 
                              
                  
                        (b)
                     
                     
                        The head of the AeMC shall be responsible for coordinating the assessment of examination results and signing reports, certificates, and initial class 1 medical certificates.
                     
                  
               ORA.AeMC.215   Facility requirements
            
            The AeMC shall be equipped with medico-technical facilities adequate to perform aero-medical examinations necessary for the exercise of the privileges included in the scope of the approval.
            
               ORA.AeMC.220   Record-keeping
            
            In addition to the records required in ORA.GEN.220, the AeMC shall:
            
                        (a)
                     
                     
                        maintain records with details of medical examinations and assessments performed for the issue, revalidation or renewal of medical certificates and their results, for a minimum period of 10 years after the last examination date; and
                     
                  
                        (b)
                     
                     
                        keep all medical records in a way that ensures that medical confidentiality is respected at all times.
                     
                  ’
      
         (1)  OJ L 167, 4.7.2003, p. 23.
      
         (2)  OJ L 295, 12.11.2010, p. 35.
      
         (3)  OJ L 167, 4.7.2003, p. 23.
      
         (4)  OJ L 294, 13.11.2007, p. 3.
      
         (5)  OJ L 295, 14.11.2007, p. 7.