ARA.MED.120 Medical assessors

Regulation (EU) No 1178/2011

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.

AMC1 ARA.MED.120 Medical assessors

ED Decision 2012/006/R

EXPERIENCE AND KNOWLEDGE

Medical assessors should:

(a)  have considerable experience of aero-medical practice and have undertaken a minimum of 200 class 1 medical examinations or equivalent; and

(b)  maintain their medical professional competence in aviation medicine. The following should count towards maintaining medical professional competence:

(1)  undertaking regular refresher training;

(2)  participating in international aviation medicine conferences;

(3)  undertaking research activities, including publication of results of the research.

AMC2 ARA.MED.120 Medical assessors

ED Decision 2012/006/R

TASKS

Medical assessors should:

(a)  provide lectures in basic, advanced and refresher training courses for aero-medical examiners (AMEs) and aero-medical centres (AeMCs);

(b)  carry out supervision and audits of AeMCs, AMEs and AME training facilities; and

(c)  perform the aero-medical assessment of applicants for, or holders of, medical certificates after referral to the licensing authority.

ARA.MED.125 Referral to the licensing authority

Regulation (EU) No 290/2012

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.

AMC1 ARA.MED.125 Referral to the licensing authority

ED Decision 2012/006/R

REFERRAL TO THE LICENSING AUTHORITY

(a)  The licensing authority should supply the AeMC or AME with all necessary information that led to the decision on aero-medical fitness.

(b)  The licensing authority should ensure that unusual or borderline cases are evaluated on a common basis.

ARA.MED.130 Medical certificate format

Regulation (EU) No 245/2014

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 andlatin 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:

(i) Class 1 single pilot commercial operations carrying passengers, ) 

(ii) Class 1 other commercial operations,

(iii) Class 2,

(iv) 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. 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: Certificates 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.

AMC1 ARA.MED.130 Medical certificate format

ED Decision 2014/020/R

STANDARD EASA MEDICAL CERTIFICATE FORMAT

The format of the medical certificate should be as shown below.

* Date of issue is the date the certificate is issued and signed

ARA.MED.135 Aero-medical forms

Regulation (EU) No 290/2012

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.

AMC1 ARA.MED.135(a) Aero-medical forms

ED Decision 2019/002/R

APPLICATION FORM FOR A MEDICAL CERTIFICATE

The form referred to in ARA.MED.135(a) should reflect the information indicated in the following form and corresponding instructions for completion.

LOGO

CIVIL AVIATION ADMINISTRATION / MEMBER STATE

APPLICATION FORM FOR A MEDICAL CERTIFICATE

Complete this page fully and in block capitals - Refer to instructions pages for details.

MEDICAL IN CONFIDENCE

General and medical history: Do you have, or have you ever had, any of the following? (Please tick). If yes, give details in remarks section (30).

INSTRUCTIONS FOR COMPLETION OF THE APPLICATION FORM FOR A MEDICAL CERTIFICATE

This application form and all attached report forms will be transmitted to the licensing authority. Medical confidentiality shall be respected at all times.

The applicant should personally complete, in full, all questions (sections) on the application form. Writing should be legible and in block capitals, using a ball-point pen. Completion of this form by typing/printing is also acceptable. If more space is required to answer any questions, a plain sheet of paper should be used, bearing the applicant’s name and signature, and the date of signing. The following numbered instructions apply to the numbered headings on the application form for a medical certificate.

Failure to complete the application form in full, or to write legibly, may result in non-acceptance of the application form. The making of false or misleading statements or the withholding of relevant information in respect of this application may result in criminal prosecution, denial of this application and/or withdrawal of any medical certificate(s) granted.

AMC1 ARA.MED.135(b);(c) Aero-medical forms

ED Decision 2012/006/R

MEDICAL EXAMINATION REPORT FORMS

The forms referred to in ARA.MED.135(b) and (c) should reflect the information indicated in the following forms and corresponding instructions for completion.

MEDICAL EXAMINATION REPORT FORM FOR CLASS 1 & CLASS 2 APPLICANTS

MEDICAL IN CONFIDENCE

Clinical exam: Check each item                          Normal      Abnormal                                                                                            Normal      Abnormal

Visual acuity                                                                        

(229) Distant vision at 5m/6m                                                                        (236) Pulmonary function              (237) Haemoglobin

(249) AME declaration:

Shaded areas do not require completion

MEDICAL EXAMINATION REPORT FORM FOR LAPL APPLICANTS

MEDICAL IN CONFIDENCE

Clinical exam: Check each item                          Normal      Abnormal                                                                                            Normal      Abnormal

Visual acuity                                                                        

(229) Distant vision at 5m/6m                                                                        (236) Pulmonary function              (237) Haemoglobin

(249) AME/GMP declaration:

INSTRUCTIONS FOR COMPLETION OF THE MEDICAL EXAMINATION REPORT FORMS

The AME performing the examination should verify the identity of the applicant.

All questions (sections) on the medical examination report form should be completed in full. If an otorhinolaryngology examination report form is attached, then questions 209, 210, 211, and 234 may be omitted. If an ophthalmology examination report form is attached, then questions 212, 213, 214, 229, 230, 231, 232, and 233 may be omitted.

Writing should be legible and in block capitals using a ball-point pen. Completion of this form by typing/printing is also acceptable. If more space is required to answer any question, a plain sheet of paper should be used, bearing the applicant’s name, the AME’s name and signature, and the date of signing. The following numbered instructions apply to the numbered headings on the medical examination report form.

Failure to complete the medical examination report form in full, as required, or to write legibly, may result in non-acceptance of the application in total and may lead to withdrawal of any medical certificate issued. The making of false or misleading statements or the withholding of relevant information by an AME may result in criminal prosecution, denial of an application or withdrawal of any medical certificate(s) granted.

Shaded areas do not require completion for the medical examination report form for the LAPL.

201 EXAMINATION CATEGORY – Tick appropriate box.

Initial – Initial examination for either LAPL, class 1 or 2; also initial examination for upgrading from LAPL to class 2, or class 2 to 1 (notate ‘upgrading’ in box 248).

Renewal/Revalidation – Subsequent ROUTINE examinations.

Extended Renewal/Revalidation – Subsequent ROUTINE examinations, which include comprehensive ophthalmological and otorhinolaryngology examinations.

202 HEIGHT – Measure height, without shoes, in centimetres to nearest cm.

203 WEIGHT – Measure weight, in indoor clothes, in kilograms to nearest kg.

204 COLOUR EYE – State colour of applicant’s eyes from the following list: brown, blue, green, hazel, grey, multi.

205 COLOUR HAIR – State colour of applicant’s hair from the following list: brown, black, red, fair, bald.

206 BLOOD PRESSURE – Blood pressure readings should be recorded as Phase 1 for Systolic pressure and Phase 5 for Diastolic pressure. The applicant should be seated and rested. Recordings in mm Hg.

207 PULSE (RESTING) – The pulse rate should be recorded in beats per minute and the rhythm should be recorded as regular or irregular. Further comments if necessary may be written in section 228, 248 or separately.

208 to 227 inclusive constitute the general clinical examination, and each of the boxes should be marked (with a tick) as normal or abnormal.

208 HEAD, FACE, NECK, SCALP – To include appearance, range of neck and facial movements, symmetry, etc.

209 MOUTH, THROAT, TEETH – To include appearance of buccal cavity, palate motility, tonsillar area, pharynx and also gums, teeth and tongue.

210 NOSE, SINUSES – To include appearance and any evidence of nasal obstruction or sinus tenderness on palpation.

211 EARS, DRUMS, EARDRUM MOTILITY – To include otoscopy of external ear, canal, tympanic membrane. Eardrum motility by valsalva manoeuvre or by pneumatic otoscopy.

212 EYES – ORBIT AND ADNEXA; VISUAL FIELDS – To include appearance, position and movement of eyes and their surrounding structures in general, including eyelids and conjunctiva. Visual fields check by campimetry, perimetry or confrontation.

213 EYES – PUPILS AND OPTIC FUNDI – To include appearance, size, reflexes, red reflex and fundoscopy. Special note of corneal scars.

214 EYES – OCULAR MOTILITY, NYSTAGMUS – To include range of movement of eyes in all directions; symmetry of movement of both eyes; ocular muscle balance; convergence; accommodation; signs of nystagmus.

215 LUNGS, CHEST, BREASTS – To include inspection of chest for deformities, operation scars, abnormality of respiratory movement, auscultation of breath sounds. Physical examination of female applicant’s breasts should only be performed with informed consent.

216 HEART – To include apical heartbeat, position, auscultation for murmurs, carotid bruits, palpation for trills.

217 VASCULAR SYSTEM – To include examination for varicose veins, character and feel of pulse, peripheral pulses, evidence of peripheral circulatory disease.

218 ABDOMEN, HERNIA, LIVER, SPLEEN – To include inspection of abdomen; palpation of internal organs; check for inquinal hernias in particular.

219 ANUS, RECTUM – Examination only with informed consent.

220 GENITO-URINARY SYSTEM – To include renal palpation; inspection palpation male/female reproductive organs only with informed consent.

221 ENDOCRINE SYSTEM – To include inspection, palpation for evidence of hormonal abnormalities/imbalance; thyroid gland.

222 UPPER AND LOWER LIMBS, JOINTS – To include full range of movements of joints and limbs, any deformities, weakness or loss. Evidence of arthritis.

223 SPINE, OTHER MUSCULOSKELETAL – To include range of movements, abnormalities of joints.

224 NEUROLOGIC – REFLEXES ETC. To include reflexes, sensation, power, vestibular system – balance, romberg test, etc.

225 PSYCHIATRIC – To include appearance, appropriate mood/thought, unusual behaviour.

226 SKIN, IDENTIFYING MARKS AND LYMPHATICS – To include inspection of skin; inspection, palpation for lymphadenopathy, etc. Briefly describe scars, tattoos, birthmarks, etc. which could be used for identification purposes.

227 GENERAL SYSTEMIC – All other areas, systems and nutritional status.

228 NOTES – Any notes, comments or abnormalities to be described – extra notes if required on separate sheet of paper, signed and dated.

229 DISTANT VISION AT 5/6 METRES – Each eye to be examined separately and then both together. First without correction, then with spectacles (if used) and lastly with contact lenses, if used. Record visual acuity in appropriate boxes. Visual acuity to be tested at either 5 or 6 metres with the appropriate chart for the distance.

230 INTERMEDIATE VISION AT 100 CM – Each eye to be examined separately and then both together. First without correction, then with spectacles if used and lastly with contact lenses if used. Record visual acuity in appropriate boxes as ability to read N14 at 100 cm (Yes/No).

231 NEAR VISION AT 30-50 CM. – Each eye to be examined separately and then both together. First without correction, then with spectacles if used and lastly with contact lenses, if used. Record visual acuity in appropriate boxes as ability to read N5 at 30-50 cm (Yes/No).

Note: Bifocal contact lenses and contact lenses correcting for near vision only are not acceptable.

232 SPECTACLES – Tick appropriate box signifying if spectacles are or are not worn by applicant. If used, state whether unifocal, bifocal, varifocal or look-over.

233 CONTACT LENSES – Tick appropriate box signifying if contact lenses are or are not worn. If worn, state type from the following list; hard, soft, gas-permeable or disposable.

313 COLOUR PERCEPTION – Tick appropriate box signifying if colour perception is normal or not. If abnormal; state number of plates of the first 15 of the pseudo-isochromatic plates (Ishihara 24 plates) have not been read correctly.

234 HEARING – Tick appropriate box to indicate hearing level ability as tested separately in each ear at 2 m.

235 URINALYSIS – State whether result of urinalysis is normal or not by ticking appropriate box. If no abnormal constituents, state NIL in each appropriate box.

236 PULMONARY FUNCTION – When required or on indication, state actual FEV1/FVC value obtained in % and state if normal or not with reference to height, age, sex and race.

237 HAEMOGLOBIN – Enter actual haemoglobin test result and state units used. Then state whether normal value or not, by ticking appropriate box.

238 to 244 inclusive: ACCOMPANYING REPORTS – One box opposite each of these sections must be ticked. If the test is not required and has not been performed, then tick the NOT PERFORMED box. If the test has been performed (whether required or on indication) complete the normal or abnormal box as appropriate. In the case of question 244, the number of other accompanying reports must be stated.

247 AME RECOMMENDATION – The applicant’s name, date of birth and reference number, should be entered here in block capitals. The applicable class of medical certificate should be indicated by a tick in the appropriate box. If a fit assessment is recommended and a medical certificate has been issued, this should be indicated in the appropriate box. An applicant may be recommended as fit for a lower class of medical certificate (e.g. class 2), but also be deferred or recommended as unfit for a higher class of medical certificate (e.g. class 1). If an unfit recommendation is made, applicable Part-MED paragraph references should be entered. If an applicant is deferred for further evaluation, the reason and the doctor or licensing authority to whom the applicant is referred should be indicated.

248 COMMENTS, LIMITATIONS, ETC. – The AME’s findings and assessment of any abnormality in the history or examination, should be entered here. The AME should also state any limitation required.

249 AME DETAILS – The AME should sign the declaration, complete his/her name and address in block capitals, contact details and lastly stamp the relevant section with his/her designated AME stamp incorporating his/her AME number. The GMP identification no. is the number provided by the national medical system.

250 PLACE AND DATE – The place (town or city) and the date of examination should be entered here. The date of examination is the date of the general examination and not the date of finalisation of the form. If the medical examination report is finalised on a different date, the date of finalisation should be entered in section 248 as ‘Report finalised on .......’.

GM1 ARA.MED.135(b);(c) Aero-medical forms

ED Decision 2012/006/R

OPHTHALMOLOGY AND OTORHINOLARYNGOLOGY EXAMINATION REPORT FORMS

The ophthalmology and otorhinolaryngology examination report forms may be used as indicated in the following forms and corresponding instructions for completion.

OPHTHALMOLOGY EXAMINATION REPORT FORM

Complete this page fully and in block capitals – Refer to instructions for completion.

MEDICAL IN CONFIDENCE

Applicant’s details

Clinical examination      Visual acuity

(321) Ophthalmological remarks and recommendation:

(322) Examiner’s declaration:

INSTRUCTIONS FOR COMPLETION OF THE OPHTHALMOLOGY EXAMINATION REPORT FORM

Writing should be legible and in block capitals using a ball-point pen. Completion of this form by typing or printing is also acceptable. If more space is required to answer any question, a plain sheet of paper should be used, bearing the applicant’s name, the name and signature of the AME or ophthalmology specialist performing the examination and the date of signing. The following numbered instructions apply to the numbered headings on the ophthalmology examination report form.

Failure to complete the medical examination report form in full, as required, or to write legibly may result in non-acceptance of the application in total and may lead to withdrawal of any medical certificate issued. The making of false or misleading statements or the withholding of relevant information by an examiner may result in criminal prosecution, denial of an application or withdrawal of any medical certificate granted.

The AME or ophthalmology specialist performing the examination should verify the identity of the applicant. The applicant should then be requested to complete the sections 1, 2, 3, 4, 5, 6, 7, 12 and 13 on the form and then sign and date the consent to release of medical information (section 301) with the examiner countersigning as witness.

302  EXAMINATION CATEGORY – Tick appropriate box.

Initial – Initial examination for either class 1 or 2; also initial examination for upgrading from class 2 to 1 (notate ‘upgrading’ in section 303).

Renewal/Revalidation – Subsequent comprehensive ophthalmological examinations (due to refractive error).

Special referral – NON-ROUTINE examination for assessment of an ophthalmological symptom or finding.

303 OPHTHALMOLOGICAL HISTORY – Detail here any history of note or reasons for special referral.

304 to 309 inclusive: CLINICAL EXAMINATION – These sections together cover the general clinical examination and each of the sections should be marked (with a tick) as normal or abnormal. Any abnormal findings or comments on findings should be entered in section 321.

310 CONVERGENCE – Enter near point of convergence in cm, as measured using RAF near point rule or equivalent. Tick whether normal or abnormal. Any abnormal findings or comments on findings should be entered in section 321.

311 ACCOMMODATION – Enter measurement recorded in dioptres using RAF near point rule or equivalent. Tick whether normal or abnormal. Any abnormal findings or comments on findings should be entered in section 321.

312 OCULAR MUSCLE BALANCE – Ocular muscle balance is tested at distant 5 or 6 m and near at 30-50 cm and results recorded. Presence of tropia or phoria must be entered accordingly and also whether fusional reserve testing was NOT performed and if performed whether normal or not.

313 COLOUR PERCEPTION – Enter type of pseudo-isochromatic plates (ishihara) as well as number of plates presented with number of errors made by examinee. State whether advanced colour perception testing is indicated and what methods used (which colour lantern or anomaloscopy) and finally whether judged to be colour safe or unsafe. Advanced colour perception testing is usually only required for initial assessment, unless indicated by change in applicant’s colour perception.

314–316 VISUAL ACUITY TESTING AT 5 m/6 m, 1 m and 30-50 cm – Record actual visual acuity obtained in appropriate boxes. If correction not worn nor required, put line through corrected vision boxes. Distant visual acuity to be tested at either 5 m or 6 m with the appropriate chart for that distance.

317 REFRACTION – Record results of refraction. Indicate also whether for class 2 applicants, refraction details are based upon spectacle prescription.

318 SPECTACLES – Tick appropriate box signifying if spectacles are or are not worn by applicant. If used, state whether unifocal, bifocal, varifocal or look-over.

319 CONTACT LENSES – Tick appropriate box signifying if contact lenses are or are not worn. If worn, state type from the following list; hard, soft, gas-permeable, disposable.

320 INTRA-OCULAR PRESSURE – Enter intra-ocular pressure recorded for right and left eyes and indicate whether normal or not. Also indicate method used – applanation, air etc.

321 OPHTHALMOLOGICAL REMARKS AND RECOMMENDATION – Enter here all remarks, abnormal findings and assessment results. Also enter any limitations recommended. If there is any doubt about findings or recommendations, the examiner may contact the AMS for advice before finalising the report form.

322 OPHTHALMOLOGY EXAMINER’S DETAILS – The ophthalmology examiner must sign the declaration, complete his/her name and address in block capitals, contact details and lastly stamp the report with his/her designated stamp incorporating his/her AME or specialist number.

323 PLACE AND DATE – Enter the place (town or city) and the date of examination. The date of examination is the date of the clinical examination and not the date of finalisation of form. If the ophthalmology examination report is finalised on a different date, enter date of finalisation on section 321 as ‘Report finalised on ............’.

OTORHINOLARYNGOLOGY EXAMINATION REPORT FORM

Complete this page fully and in block capitals – Refer to instructions for completion.

MEDICAL IN CONFIDENCE

Applicant’s details

Clinical examination

INSTRUCTIONS FOR COMPLETION OF THE OTORHINOLARYNGOLOGY EXAMINATION REPORT FORM

Writing should be legible and in block capitals using a ball-point pen. Completion of this form by typing or printing is also acceptable. If more space is required to answer any question, a plain sheet of paper should be used, bearing the applicant’s name, the name and signature of the AME or otorhinolaryngology specialist performing the examination and the date of signing. The following numbered instructions apply to the numbered headings on the otorhinolaryngology examination report form.

Failure to complete the medical examination report form in full, as required, or to write legibly may result in non-acceptance of the application in total and may lead to withdrawal of any medical certificate issued. The making of false or misleading statements or the withholding of relevant information by an examiner may result in criminal prosecution, denial of an application or withdrawal of any medical certificate granted.

The AME or otorhinolaryngology specialist performing the examination should verify the identity of the applicant. The applicant should then be requested to complete the sections 1, 2, 3, 4, 5, 6, 7, 12 and 13 on the form and then sign and date the consent to release of medical information (section 401) with the examiner countersigning as witness.

402 EXAMINATION CATEGORY – Tick appropriate box.

Initial – Initial examination for class 1; also initial examination for upgrading from class 2 to 1 (notate upgrading’ in section 403)

Special Referral – NON-ROUTINE examination for assessment of an ORL symptom or finding

403 OTORHINOLARYNGOLOGICAL HISTORY – Detail here any history of note or reasons for special referral.

404-413 inclusive: CLINICAL EXAMINATION – These sections together cover the general clinical examination and each of the sections should be marked (with a tick) as normal or abnormal. Any abnormal findings or comments on findings should be entered in section 421.

414-418 inclusive: ADDITIONAL TESTING – These tests are only required to be performed if indicated by history or clinical findings and are not routinely required. For each test one of the boxes must be completed – if the test is not performed then tick that box – if the test has been performed then tick the appropriate box for a normal or abnormal result. All remarks and abnormal findings should be entered in section 421.

419 PURE TONE AUDIOMETRY – Complete figures for dB HL (hearing level) in each ear at all listed frequencies.

420 AUDIOGRAM – Complete audiogram from figures as listed in section 419.

421 OTORHINOLARYNGOLOGY REMARKS AND RECOMMENDATION – Enter here all remarks, abnormal findings and assessment results. Also enter any limitations recommended. If there is any doubt about findings or recommendations the examiner may contact the AMS for advice before finalising the report form.

422 OTORHINOLARYNGOLOGY EXAMINER’S DETAILS – The otorhinolaryngology examiner must sign the declaration, complete his/her name and address in block capitals, contact details and lastly stamp the report with his/her designated stamp incorporating his/her AME or specialist number.

423 PLACE AND DATE – Enter the place (town or city) and the date of examination. The date of examination is the date of the clinical examination and not the date of finalisation of form. If the ORL examination report is finalised on a different date, enter date of finalisation in section 421 as ‘Report finalised on ........’.

ARA.MED.145 GMP notification to the competent authority

Regulation (EU) No 290/2012

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

Regulation (EU) No 1178/2011

(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) anAeMC, 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.

AMC1 ARA.MED.150 Record-keeping

ED Decision 2012/006/R

RELEASE OF AERO-MEDICAL RECORDS

In accordance with Directive 95/46/EC as implemented under national law, aero-medical records may also be released:

(a)  upon written request of the applicant, to management of the competent authority, for review in response to a complaint;

(b)  to research institutes for the purpose of scientific research, with assurance of de-identification prior to publication;

(c)  to any investigation body (accident, security, police), when required under national law; and

(d)  for any other circumstances, as required under national law.

ARA.MED.160 Exchange of information on medical certificates through a central repository.

Regulation (EU) 2019/27

(a) The Agency shall establish and manage a central repository, the European Aero-Medical Repository (EAMR).

(b) For the purposes of medical certification and oversight of applicants for and holders of class 1 medical certificates and for the oversight of AMEs and AeMCs, the persons referred to in point (c) shall exchange the following information through EAMR:

(1) basic data of the applicant for or holder of a class 1 medical certificate: licensing authority; surname and forename; date of birth; nationality; email address and the number of one or more identification documents (national identity card or passport) as provided by the applicant;

(2)  class 1 medical certificate data: date of the medical examination or, in case the medical examination is not finalised, the date of initiation of the medical examination; dates of issuing and of expiration of the class 1 medical certificate; place of the examination; status of limitations; status of that certificate (new, released, suspended or revoked); unique reference number of the medical assessor of the licensing authority; AME or AeMC issuing that certificate and of its competent authority.

(c) For the purposes of point (b), the following persons shall have access to EAMR and the information contained therein:

(1) medical assessors of the licensing authority of the applicant for or holder of a class 1 medical certificate, as well as any other duly authorised personnel of that authority in charge of creating or managing the record of that applicant or holder as required by this Regulation;

(2) AMEs and any duly authorised personnel of AeMCs to whom that applicant or holder has provided a declaration in accordance with point MED.A.035(b)(2);

(3) any duly authorised personnel of the competent authority responsible for the oversight of AMEs or AeMCs conducting aero-medical assessments of those applicants or holders.

In addition, the Agency and national competent authorities may grant access to EAMR and the information contained therein to other persons, where necessary for the purposes of ensuring the proper functioning of EAMR, in particular its technical maintenance. In that case, the Agency or the national competent authority concerned shall ensure that those persons are duly authorised and qualified, that their access remains limited to what is necessary for the purposes for which they have been granted access and that they have received prior training on the applicable personal data protection legislation and related safeguards. Whenever a competent authority grants a person such access, it shall inform the Agency beforehand.

(d) The licensing authorities, AMEs and AeMCs referred to in point (c) shall, each time immediately upon having examined an applicant for or a holder of a class 1 medical certificate, enter the data referred to in point (b) into EAMR or update that data where necessary.

 (e)  Where the data constitutes personal data as defined in point a of Article 2 of Regulation (EC) No 45/2001²⁵Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1)., they shall, each time when entering or updating that data, inform, ex ante, the applicant for or holder of the class 1 certificate thereof.

(f)  The Agency shall ensure the integrity and security of EAMR and the information contained therein by appropriate information technology infrastructure. It shall establish and apply, in consultation with the national competent authorities, the protocols and technological measures necessary to ensure that any access to EAMR and the information contained therein is lawful and secure.

(g)  The Agency shall ensure that any information contained in EAMR is deleted after a period of 10 years. That period shall be calculated from the date of expiration of the last class 1 certificate issued in respect of the applicant or holder concerned, or from the date of the last entry or update of data in respect of that applicant or holder, whichever date is later.

(h)   The Agency shall ensure that applicants for or holders of class 1 medical certificates can access any information relating to them contained in EAMR and that they are informed that they can request that information to be rectified or deleted. The licensing authorities shall assess such requests and, where they consider that the information concerned is incorrect or not necessary for the purposes specified in point (b), ensure that the information is rectified or deleted.’

AMC1 ARA.MED.160(b) Exchange of information on medical certificates

ED Decision 2019/002/R

DATA CATEGORIES

For the purpose of the EAMR, the information processed is divided into two categories as follows:

Category 1: Basic applicant data as described in ARA.MED.160(b)(1)

Category 2: Medical certificate data as described in ARA.MED.160(b)(2)

Typically, the following information should not be recorded:

—             Reasons for which a medical certificate has not been issued

Only the fact that no certificate has been issued should be indicated. Any need for further clarification on whether the certificate has not been issued because of medical reasons, administrative matters or interruption of the medical assessment process before reaching the conclusion should be addressed, outside the scope of the EAMR, by the medical assessor of the licensing authority associated with the applicant’s class 1 medical certificate.

—             Details of the limitations associated with a given medical certificate

Only a ‘Yes/No’ status on the existence of such a limitation should be recorded. Any need for further clarification on the limitation(s) should be addressed, outside the scope of the EAMR, by the medical assessor of the licensing authority associated with the applicant’s class 1 medical certificate.

AMC1 ARA.MED.160(c) Exchange of information on medical certificates

ED Decision 2019/002/R

ROLE OF THE COMPETENT AUTHORITIES

Each competent authority should:

(a)  designate its EAMR administrator;

(b)  ensure control and oversight of all personnel managing or using the EAMR.

AMC2 ARA.MED.160(c) Exchange of information on medical certificates

ED Decision 2019/002/R

RESTRICTED ACCESS TO INFORMATION

Each competent authority should restrict access to personal data in the EAMR on need-to-know basis as follows:

AMC3 ARA.MED.160(c) Exchange of information on medical certificates

ED Decision 2019/002/R

USE OF THE EAMR

The competent authority should ensure that:

(a)  all personnel accessing the EAMR are trained and proficient in using the system and having the necessary knowledge for implementing the applicable data protection legislation;

(b)  the oversight of persons and organisations, subject to Regulation (EU) No 2018/1139 and its implementing rules, includes the assessment of compliance with the provisions applicable to the use and functioning of the EAMR.

AMC1 ARA.MED.160(d) Exchange of information on medical certificates

ED Decision 2019/002/R

APPLICANT’S RECORD

Each competent authority should ensure that:

(a)  for each applicant for a class 1 medical certificate, a unique personal record is created in the EAMR, containing the category 1 personal data listed in ARA.MED.160(b)(1). This record is referred to as the ‘applicant’s record’;

(b)  the applicant’s record is managed in accordance with the applicable regulation (typically for inserting, updating, viewing, validating data, etc.).

(c)  an applicant is granted the right to obtain, without undue delay, the rectification of inaccurate personal data concerning them and, taking into account the purposes of the EAMR, the applicant is granted the right to have incomplete personal data completed. Such corrections should also be mirrored in the associated records kept in accordance with ARA.MED.150.

(d)  the data recorded in the EAMR is complete as relevant for the purpose of the EAMR as described in AMC1 ARA.MED.160(b).

AMC1 ARA.MED.160(d) Exchange of information on medical certificates

ED Decision 2019/002/R

RECOVERY FROM UNSERVICEABILITY

The competent authority should ensure that class 1 medical certificates issued or amended without being properly recorded in the EAMR, due to unserviceability of the system, are entered in the EAMR without undue delay when the system recovers.

AMC1 ARA.MED.160(h) Exchange of information on medical certificates

ED Decision 2019/002/R

INFORMATION OF APPLICANTS

The competent authority should ensure at least the following:

(a)  At the time of the creation of the applicant’s record at the latest, the applicants should be informed:

(1)  that their personal data as listed in ARA.MED.160(b)(1) will be lawfully processed in a European central repository, in accordance with Article 72 of Regulation (EU) 2018/1139 and ARA.GEN.200(c) and ARA.MED.160 of Commission Regulation (EU) No 1178/2011.

(2)  that the purpose of the processing is to verify that the information, as regards their previous medical certificates, provided in their declaration submitted in accordance with MED.A.035(b)(2), is consistent with the records available to all competent authorities in accordance with ARA.MED.150;

(3)  of the contact details of the data protection officer as applicable;

(4) that the period for which the personal data will be stored is determined in accordance with ARA.MED.160(g);

(5) of the existence of their right to request access to, and rectification of personal data;

(6)  of the contact details of the data controller;

(7)  of their right to lodge a complaint with the competent data protection authority in accordance with the applicable data protection legislation;

(8) that it is ensured that access to personal data contained in the EAMR is restricted to authorised personnel in accordance with Commission Regulation (EU) No 1178/2011.

(b) When applying for a class 1 medical certificate, the applicants should be informed that the category 2 data of their medical certificate, as listed in ARA.MED.160(b)(2), will be processed to verify that the information provided in their declaration, as regards their previous medical certificates, is consistent with the information available in the EAMR.