Professional Documents
Culture Documents
: : : :
DOCUMENT APPROVAL
AUTHORITY
DATE
21-12-2012
Head of HANSA
Nikolaos ILIAS
21-12-2012
Page ii
AMENDMENT RECORD
Amendment Number
Subject
Edition Date
Page iii
CONTENTS
Page 1
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
Page 2
Page 3
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.
Page 4
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.
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.
Page 5
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.
Page 6
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.
6.2.
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.
Page 7
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
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.
7.2.
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
Page 8
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.
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.
Page 9
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.
Page 10