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HANSA Procedure for Approval and Oversight of Aero Medical Examiners and Aero Medical Centres for European

Class 3 Medical Certificate applicants

Edition Edition Date Status Class

: : : :

1.0 21 Dec 2012 Released Issue Public

HANSA Procedure for Approval and Oversight of AMEs and AeMCs

DOCUMENT APPROVAL

AUTHORITY

NAME AND SIGNATURE Michael PANAGIOTOPOULOS

DATE
21-12-2012

Head of HANSA

Head of Human & Financial Resources Section at HANSA

Nikolaos ILIAS

21-12-2012

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HANSA Procedure for Approval and Oversight of AMEs and AeMCs

AMENDMENT RECORD

Amendment Number

Subject

Edition Date

Date of entry into force

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CONTENTS

DOCUMENT APPROVAL ...........................................................................................ii AMENDMENT RECORD ..................................................................................................iii CONTENTS.................................................................................................................1


1. 2. 3. 4. 5. Objective ....................................................................................................................................2 Definitions ..................................................................................................................................2 Applicability ................................................................................................................................2 European Class 3 Medical Fitness requirements and their application .............................................3 European Class 3 Medical Fitness Assessments ..............................................................................3 General 3 Qualifications of AMEs ......................................................................................................................4 Privileges of AMEs.............................................................................................................................4 Initial AME Approval .........................................................................................................................4 Revalidation of AME Approval............................................................................................................5 Qualifications of AeMCs ....................................................................................................................5 Initial European Class 3 medical fitness Examinations and assessment ................................................6 Revalidation and Renewal Examinations and assessment for European Class 3 Medical Certificates ..........................................................................................................................6 6. Obligations of Aero Medical Examiners .........................................................................................7 AME Competence .............................................................................................................................7 Medical Record Keeping ....................................................................................................................8 Purpose of Examinations ...................................................................................................................8 7. OBLIGATIONS OF THE AMS ...........................................................................................................8 AME/AeMC Competence ...................................................................................................................8 Rules and Procedures ........................................................................................................................9 Medical Record Keeping ....................................................................................................................9 Review/Appeal Mechanism .............................................................................................................10

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HANSA Procedure for Approval and Oversight of AMEs and AeMCs

This Procedure has been developed by the Hellenic Air Navigation Supervisory Authority (HANSA) with regard to Regulation (EU) 805/2011 laying down detailed rules for air traffic controllers (ATCOs) licences and European Class 3 Medical fitness Certificate, pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council and in particular Chapter III concerning Medical Certification.

1. Objective
1.1. The objective of this Procedure is to set out the detailed rules for approval and oversight of aero medical examiners for European Class 3 Medical fitness Certificate for ATCOs in accordance with Regulation EU 805/2011.

2. Definitions
2.1. The Regulation means Regulation EU 805/20111 laying down detailed rules for air traffic controllers licences and certain certificates pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council; 2.2. Aero-medical Centre (AeMC) means an organisation qualified for the issue or continuation of an approval to issue medical certificates, including initial class 1 medical certificates; 2.3. Aero Medical Examiner (AME) means a medical examiner qualified and licensed in the practice of medicine and having received the appropriate training in aviation medicine to conduct Class 3 medical examinations

3. Applicability
3.1. This Procedure shall apply to: The designated competent Aero Medical Section (AMS) The approved Aero Medical Examiners/ Centres (AME/AeMC) All prospective candidates for the issuance/ renewal revalidation of European Class 3 Medical Certificates, as above

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4. European Class 3 Medical Fitness requirements and their application


4.1. According to Article 15 of the Regulation issuing of medical fitness certificates for ATCOs shall be consistent with the provisions of Annex I to the Chicago Convention on International Civil Aviation and, simultaneously, with the Requirements for European Class 3 Medical Certification of Air Traffic Controllers, as laid down by Eurocontrol. The efficient application of the European Class 3 Medical fitness requirements for any legal applicant and specially for ATCOs as detailed in Chapter III of the Regulation, is the responsibility of HANSA, acting through the designated AMS and using the approved AME/AeMCs as medical implementation body to perform the medical examinations and assessments. 4.2. An external Aero Medical Body shall be nominated and designated by HANSA through a Memorandum of Cooperation as the competent AMS regarding the oversight and the application of the medical fitness requirements. The AMS shall have sole responsibility in relation to technical medical matters. Medical confidentiality shall be respected at all times. 4.3. An external Aero Medical Body shall be nominated and designated by HANSA through a Memorandum of Cooperation as the competent AMS regarding the oversight and the application of the medical fitness requirements. The AMS shall have sole responsibility in relation to technical medical matters. Medical confidentiality shall be respected at all times. 4.4. The AME shall ensure that all oral or written reports and electronically stored information on medical matters of licence holders/applicants are made available to the AMS, in order to be used by the AMS for completion of a medical assessment.

5. European Class 3 Medical Fitness Assessments


General
5.1. Medical Fitness assessments for applicants, according to European Class 3 requirements, can be performed at two, mutual exclusive, distinctive levels: 5.2. Initial Examinations and assessment, covering the first medical fitness examinations and assessment of a legal candidate or; 5.3. Revalidation / Renewal medical fitness examinations and assessment. medical

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Qualifications of AMEs
Applicant MDs for an AME approval with the privileges for the revalidation and renewal of Class 3 medical certificates shall: a. be fully qualified and licensed for the practice of medicine and hold a certificate, or have evidence, of completion of specialist training; b. have successfully completed basic and advanced training courses in aviation medicine, including specific modules for the medical assessment of air traffic controllers and the specific environment in air traffic control; c. 1) 2) demonstrate that they: have adequate facilities, procedures, documentation and functioning equipment suitable for aero-medical examinations; and have in place the necessary procedures and conditions to ensure medical confidentiality

Privileges of AMEs
a) In accordance with this Part, the privileges of an AME are to revalidate and renew Class 3 medical certificates, and to conduct the relevant medical examinations and assessments. b) The scope of the privileges of the AME, and any condition thereof, shall be specified in the Approval. c) An approved AME shall not undertake aero-medical examinations and assessments in a Member State other than the Member State that issued their certificate as an AME, unless they have: 1) been granted access by the host Member State to exercise their professional activities as a specialised doctor; 2) informed the competent authority of the host Member State of their intention to conduct aero-medical examinations and assessments and to issue medical certificates within the scope of their privileges as AME; and 3) received a briefing from the competent authority of the host Member State.

Initial AME Approval


5.4. An Approval shall be granted by HANSA to an MD for a three year period to act as Aero Medical Examiner for the renewal/revalidation of European Class 3 medical fitness certificates, on the basis of aero medical examinations and assessments. This Approval procedure is initiated after a written and signed application (see Annex) by the applicant MD, fulfilling at least the requirements of 5.1 above and following a positive written recommendation to this effect by the AMS. 5.5. This recommendation can be positive only

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after the confirmation of the qualifications of the MD as legal candidate AME /AeMC by HANSA and positive written results are established and forwarded to HANSA as findings after an inspection/audit of the legal candidate by the AMS.

Revalidation of AME Approval


5.6. An AME Approval shall be issued for a period not exceeding 3 years. It shall be revalidated after a written and signed application by the holder, subject to: 1. continuing to fulfil the general conditions required for medical practice and maintaining registration as a medical practitioner according to national law; 2. undertaking refresher training in aviation medicine and in the working environments of air traffic controllers within the last 3 years; 3. having performed at least 10 aero-medical examinations every year. This number of examinations may only be reduced by the competent authority in duly justified circumstances; 4. remaining in compliance with the terms of their Approval; and 5. exercising their privileges in accordance with the applicable procedures and related rules and regulations. 5.7. Revalidation of an AME Approval shall be given by HANSA to applicant MDs acting previously as Aero Medical Examiners only following a positive recommendation to this effect by the AMS.

Qualifications of AeMCs
5.8. Aero Medical Centers (AeMCs) must meet at least the following conditions:

a. have all the means necessary for the scope of responsibilities associated with their privileges. These means comprise but are not limited to the following: facilities, personnel, equipment, tools and material, documentation of tasks, responsibilities and procedures, access to relevant data and appropriate record-keeping; b. implement and maintain a management system relating to safety (SMS) and the standards of medical assessment, and aim for continuous improvement of this system; c. have an established relation with other relevant medical, scientific organizations, institutes and foundations, as necessary, to ensure that it is possible the in depth medical investigation of border line applicants if needed.

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Initial European Class 3 medical fitness Examinations and assessment


5.9. These examinations shall be performed by an AeMC having a valid approval and meeting at least the criteria defined in paragraph 5.5 above. 5.10. A copy of the full medical archive of the applicant for a European Class 3 medical fitness certificate shall be sent in an electronic manner to the AMS. 5.11. A full applicants archive is including: the application form signed by the applicant, the full medical examinations report and has as attachments the results of all clinical examinations performed (e.g. ECG, lipid profile, audiograms etc ) as they are required or as clinically indicated. A proposal for an assessment of the applicant, signed by the head of the AeMC, must also be included. 5.12. The e -copy of the applicants archive must be sent to the medical assessors of the AMS by the head of the AeMC, immediately after the completion of the medical examinations/assessment 5.13. In the case of a fit initial applicant, the AMS issues the medical fitness certificate and a copy of the Medical Certificate shall be sent to the HANSA. 5.14. In the case of an unfit applicant, the applicant must be notified in written about the reasons of his/her unfitness (letter of denial). 5.15. Medical confidentiality must be maintained at all times

Revalidation and Renewal Examinations and assessment for European Class 3 Medical Certificates
5.16. Revalidation and renewal examinations and assessment shall be performed by approved AeMCs/ AMEs, having their approval in valid. 5.17. The AeMC/AME shall have the responsibility for the medical examinations, as required, and for the aeromedical fitness assessment of the applicant . 5.18. In the case of a fit applicant, the AeMC/AME issues the medical fitness certificate and a copy of the Medical Certificate shall be sent to the AMS and HANSA.

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5.19.

In the case of an unfit applicant, the applicant must be notified in written about the reasons of his/her unfitness (letter of denial).

5.20.

A copy of the full medical archive of an applicant for a European Class 3 medical fitness certificate shall be sent in an electronic manner to the AMS.

5.21.

A full archive is including: the application form signed by the applicant, the full medical examinations report and has as attachments the results of all clinical examinations

performed (eg ECG, lipid profile, audiograms etc ) as they are required or as clinically indicated. A report for the assessment about the applicant, signed by the head of the AeMC or by the AME , must also be included. 5.22. The e- copy of the applicants archive must be sent electronically to the AMS medical assessors, immediately after the completion of the medical examinations by the head of the AeMC/ AME 5.23. In the case of a border line applicant, the further investigation of him/her is performed by the AMS or, if is indicated, by AMS in consultation with medical and operational experts. 5.24. Medical confidentiality must be maintained at all times.

6. Obligations of Aero Medical Examiners


AME Competence
6.1. AMEs shall perform aero medical examinations and assessments for the issue of European Class 3 medical certificates only if they continue to meet the approval maintenance criteria defined by the HANSA.

6.2.

AMEs shall notify the competent authority of the following changes which could affect their Approval:

1) the AME is subject to disciplinary proceedings or investigation by a medical regulatory body; 2) there are any changes to the conditions on which the certificate was granted, including the content of the statements provided with the application; 3) the requirements for the issue are no longer met; 4) there is a change of the AMEs practice location(s) or correspondence address.

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b. Failure to inform the competent authority shall result in the suspension or revocation of the privileges of the Approval, on the basis of the decision of the competent authority that suspends or revokes the certificate 6.3. Any valid AME approval is subject to revocation: after a serious negative oversight report by the AMS, or after a written and signed request by the AME

Medical Record Keeping


6.4. Aero Medical Examiners shall implement appropriate medical record keeping as specified by HANSA and ensure that : all oral or written reports on medical matters by applicants are registered and electronically stored as information and are made available to the AMS for medical assessment, appeal or auditing purposes. 6.5. An AME shall be allowed access to any existing aero medical documentation held by other AMEs and is directly relevant to such examinations as that AME shall carry out.

Purpose of Examinations
6.6. Aero Medical Examiners shall make distinction between medical examinations and procedures for controller certification purposes and other examinations conducted as part of the compliance with any general national or international requirements on health and safety at work.

7. OBLIGATIONS OF THE AMS


AME/AeMC Competence
7.1. The AMS shall ensure that all European Class 3 medical certificates are initially issued by approved AeMCs and Renewed/revalidated by competent and approved AME/AeMCs.

7.2.

The AMS shall communicate to HANSA the criteria for the initial approval as well as the conditions for maintenance of the approval of AME/AeMCs, to issue European Class 3

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medical certificates. These criteria and conditions as proposed by the AMS shall be forwarded to HANSA for adoption.

7.3.

The AMS shall communicate to HANSA the details of the legal AME/AeMCs inspection /audit findings as well as the corrective measures for maintenance of the approval to issue European Class 3 medical certificates and shall forward them to the interested AME/AeMC for corrective actions .

7.4.

In case the AMS determines that an already approved by HANSA AME/AeMC no longer fulfils the criteria for the maintenance of the approval to issue European Class 3 medical certificate, it shall communicate to HANSA the details of such AME/AeMCs for the revocation/suspension of their approval. The names and details of AME/AeMCs whose approval has been revoked/suspended shall be communicated to the public trough the official web site of HANSA. At any time an updated list of all such revocations/suspensions shall be kept at the AMS and HANSA.

Rules and Procedures


7.5. The HANSA shall inform the AME/AeMCs of any detailed rules and procedures related to European Class 3 medical examination, attestation of fitness, issuing of medical certificates, and renewal periods.

7.6.

The AMS, after written notification by HANSA, shall regularly propose to HANSA reviews/amendments for the applicable procedures for issuing/renewing/revalidating European Class 3 medical certificates as required.

Medical Record Keeping


7.7. The AMS ensures that the AMEs/AeMCs dispose of an appropriate system for medical record keeping to ensure that: all oral or written reports on medical matters by applicants are registered and electronically stored as information and

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are made immediately available to the AMS for medical assessment, appeal or auditing purposes.

7.8.

All AME/AeMCs with their approval in valid, shall be allowed access to any existing aero medical documentation held by the AMS and is directly relevant to such examinations as that AME/AeMC shall carry out.

Review/Appeal Mechanism
7.9. The AMS shall dispose of an appropriate Review procedure and an Appeal mechanism which is notified and accepted by HANSA.

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