Regulation (EU) 2019/27
For the purpose of this Annex (Part-MED), the competent authority shall be:
(a) for aero-medical centres (AeMCs):
(1) the authority designated by the Member State, where the AeMC has its principal place of business;
(2) the Agency, if the AeMC is located in a third country;
(b) for aero-medical examiners (AMEs):
(1) the authority designated by the Member State where the AME has its principal place of practice;
(2) if the principal place of practice of an AME is located in a third country, the authority designated by the Member State to which the AME applies for the issue of the AME certificate;
(c) for general medical practitioners (GMPs), the authority designated by the Member State to which the GMP notify their activity;
(d) for occupational health medical practitioners (OHMPs) assessing the medical fitness of cabin crew, the authority designated by the Member State to which the OHMP notify their activity.
Regulation (EU) 2019/27
This Annex (Part-MED) establishes the requirements for:
(a) the issuance, validity, revalidation and renewal of the medical certificate required for exercising the privileges of a pilot licence or of a student pilot;
(b) the medical fitness of cabin crew;
(c) the certification of AMEs;
(d) the qualification of GMPs and OHMPs.
Regulation (EU) 2019/27
For the purpose of this Annex (Part-MED), the following definitions shall apply:
— ‘limitation’ means a condition placed on the medical certificate or cabin crew medical report that shall be complied with whilst exercising the privileges of the licence or cabin crew attestation;
— ‘aero-medical examination’ means an inspection, palpation, percussion, auscultation or any other means of investigation for determining the medical fitness to exercise the privileges of the licence, or to carry out cabin crew safety duties;
— ‘aero-medical assessment’ means the conclusion on the medical fitness of an applicant based on the evaluation of the applicant as required in this Annex (Part-MED) and further examinations and medical tests as clinically indicated;
— ‘significant’ means a degree of a medical condition, the effect of which would prevent the safe exercise of the privileges of the licence or of the cabin crew safety duties;
— ‘applicant’ means a person applying for, or being the holder of, a medical certificate who undergoes an aero-medical assessment of fitness to exercise the privileges of the licence, or to carry out cabin crew safety duties;
— ‘medical history’ means a narrative or record of past diseases, injuries, treatments or other medical facts, including unfit assessment(s) or limitation of a medical certificate, that are or may be relevant to an applicant’s current state of health and aero-medical fitness;
— ‘licensing authority’ means the competent authority of the Member State that issued the licence, or to which a person applies for the issuance of a licence, or, when a person has not yet applied for a licence, the competent authority as determined in accordance with FCL.001 of Annex I (Part-FCL);
— ‘colour safe’ means the ability of an applicant to readily distinguish the colours used in air navigation and to correctly identify aviation coloured lights;
— ‘investigation’ means the assessment of a suspected pathological condition of an applicant by means of examinations and tests in order to verify the presence or absence of a medical condition;
— ‘accredited medical conclusion’ means the conclusion reached by one or more medical experts acceptable to the licensing authority, on the basis of objective and non-discriminatory criteria, for the purposes of the case concerned, in consultation with flight operations or other experts as necessary, for which an operational risk assessment may be appropriate;
— ‘misuse of substances’ means the use of one or more psychoactive substances by aircrew in a way that, alternatively or jointly:
(a) constitutes a direct hazard to the user or endangers the lives, health or welfare of others;
(b) causes or worsens an occupational, social, mental or physical problem or disorder;
— ‘psychoactive substances’ means alcohol, opioids, cannabinoids, sedatives and hypnotics, cocaine, other psychostimulants, hallucinogens, and volatile solvents, with the exception of caffeine and tobacco;;
— ‘refractive error’ means the deviation from emmetropia measured in dioptres in the most ametropic meridian, measured by standard methods.
MED.A.015 Medical confidentiality
Regulation (EU) 2019/27
All persons involved in aero-medical examinations, assessments and certification shall ensure that medical confidentiality is respected at all times.
AMC1 MED.A.015 Medical confidentiality
ED Decision 2019/002/R
To ensure medical confidentiality, all medical reports and records should be securely held with accessibility restricted to personnel authorised by the medical assessor or, where applicable, by the head of the aero-medical centre (AEMC), the aero-medical examiner (AME), general medical practitioner (GMP) or occupational health medical practitioner (OHMP).
MED.A.020 Decrease in medical fitness
Regulation (EU) 2019/27
(a) Licence holders shall not exercise the privileges of their licence and related ratings or certificates, and student pilots shall not fly solo, at any time when they:
(1) are aware of any decrease in their medical fitness which might render them unable to safely exercise those privileges;
(2) take or use any prescribed or non-prescribed medication which is likely to interfere with the safe exercise of the privileges of the applicable licence;
(3) receive any medical, surgical or other treatment that is likely to interfere with the safe exercise of the privileges of the applicable licence.
(b) In addition, holders of a medical certificate shall, without undue delay and before exercising the privileges of their licence, seek aero-medical advice from the AeMC, AME or GMP, as applicable, when they:
(1) have undergone a surgical operation or invasive procedure;
(2) have commenced the regular use of any medication;
(3) have suffered any significant personal injury involving incapacity to function as a member of the flight crew;
(4) have been suffering from any significant illness involving incapacity to function as a member of the flight crew;
(5) are pregnant;
(6) have been admitted to hospital or medical clinic;
(7) first require correcting lenses.
(c) In the cases referred to in point (b):
(1) holders of class 1 and class 2 medical certificates shall seek the aero-medical advice of an AeMC or AME. In that case, the AeMC or AME shall assess their medical fitness and decide whether they are fit to resume the exercise of their privileges;
(2) holders of light aircraft pilot licence medical certificates shall seek the aero-medical advice of an AeMC, an AME or the GMP who signed the medical certificate. In that case, the AeMC, AME or GMP shall assess their medical fitness and decide whether they are fit to resume the exercise of their privileges.
(d) Cabin crew members shall not perform duties on an aircraft and, where applicable, shall not exercise the privileges of their cabin crew attestation when they are aware of any decrease in their medical fitness, to the extent that this medical condition might render them unable to discharge their safety duties and responsibilities.
(e) In addition, if any of the medical conditions specified in points (1) to (5) of point (b) apply, cabin crew members shall, without undue delay, seek the advice of an AME, AeMC or OHMP, as applicable. In that case, the AME, AeMC or OHMP shall assess the medical fitness of the cabin crew members and decide whether they are fit to resume their safety duties.
GM1 MED.A.020 Decrease in medical fitness
ED Decision 2019/002/R
MEDICATION – GUIDANCE FOR PILOTS AND CABIN CREW MEMBERS
(a) Any medication can cause side effects, some of which may impair the safe performance of flying duties. Equally, symptoms of colds, sore throats, diarrhoea and other abdominal upsets may cause little or no problem whilst on the ground but may distract the pilot or cabin crew member and degrade their performance whilst on duty. The in-flight environment may also increase the severity of symptoms which may only be minor whilst on the ground. Therefore, one issue with medication and flying is the underlying condition and, in addition, the symptoms may be compounded by the side effects of the medication prescribed or bought over the counter for treatment. This guidance material provides some help to pilots and cabin crew in deciding whether expert aero-medical advice by an AME, AeMC, GMP, OHMP or medical assessor is needed.
(b) Before taking any medication and acting as a pilot or cabin crew member, the following three basic questions should be satisfactorily answered:
(1) Do I feel fit to fly?
(2) Do I really need to take medication at all?
(3) Have I given this particular medication a personal trial on the ground to ensure that it will not have any adverse effects on my ability to fly?
(c) Confirming the absence of adverse effects may well need expert aero-medical advice.
(d) The following are some widely used medicines with a description of their compatibility with flying duties:
(1) Antibiotics. Antibiotics may have short-term or delayed side effects which can affect pilot or cabin crew performance. More significantly, however, their use usually indicates that an infection is present and, thus, the effects of this infection may mean that a pilot or cabin crew member is not fit to fly and should obtain expert aero-medical advice.
(2) Anti-malaria drugs. The decision on the need for anti-malaria drugs depends on the geographical areas to be visited, and the risk that the pilot or cabin crew member has of being exposed to mosquitoes and of developing malaria. An expert medical opinion should be obtained to establish whether anti-malaria drugs are needed and what kind of drugs should be used. Most of the anti-malaria drugs (atovaquone plus proguanil, chloroquine, doxycycline) are compatible with flying duties. However, adverse effects associated with mefloquine include insomnia, strange dreams, mood changes, nausea, diarrhoea and headaches. In addition, mefloquine may cause spatial disorientation and lack of fine coordination and is, therefore, not compatible with flying duties.
(3) Antihistamines. Antihistamines can cause drowsiness. They are widely used in ‘cold cures’ and in treatment of hay fever, asthma and allergic rashes. They may be in tablet form or a constituent of nose drops or sprays. In many cases, the condition itself may preclude flying, so that, if treatment is necessary, expert aero-medical advice should be sought so that so-called non-sedative antihistamines, which do not degrade human performance, can be prescribed.
(4) Cough medicines. Antitussives often contain codeine, dextromethorfan or pseudo-ephedrine which are not compatible with flying duties. However, mucolytic agents (e.g. carbocysteine) are well-tolerated and are compatible with flying duties.
(5) Decongestants. Nasal decongestants with no effect on alertness may be compatible with flying duties. However, as the underlying condition requiring the use of decongestants may be incompatible with flying duties, expert aero-medical advice should be sought. For example, oedema of the mucosal membranes causes difficulties in equalising the pressure in the ears or sinuses.
(6) Nasal corticosteroids are commonly used to treat hay fever, and they are compatible with flying duties.
(7) (i) Common pain killers and antifebrile drugs. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and paracetamol, commonly used to treat pain, fever or headaches, may be compatible with flying duties. However, the pilot or cabin crew member should give affirmative answers to the three basic questions listed in (b) before using the medication and carrying out flying duties.
(ii) Strong analgesics. The more potent analgesics including codeine are opiate derivatives, and may produce a significant decrement in human performance and, therefore, are not compatible with flying duties.
(8) Anti-ulcer medicines. Gastric secretion inhibitors such as H2 antagonists (e.g. ranitidine, cimetidine) or proton pump inhibitors (e.g. omeprazole) may be acceptable after diagnosis of the pathological condition. It is important to seek for the medical diagnosis and not to only treat the dyspeptic symptoms.
(9) Anti-diarrhoeal drugs. Loperamide is one of the more common anti-diarrhoeal drugs and is usually safe to take whilst flying. However, the diarrhoea itself often makes the pilot and cabin crew member unfit for flying duties.
(10) Hormonal contraceptives and hormone replacement therapy usually have no adverse effects and are compatible with flying duties.
(11) Erectile dysfunction medication. This medication may cause disturbances in colour vision and dizziness. There should be at least 6 hours between taking sildenafil and flying duty; and 36 hours between taking vardenafil or tadalafil and flying duty.
(12) Smoking cessation. Nicotine replacement therapy may be acceptable. However, other medication affecting the central nervous system (buproprion, varenicline) is not acceptable for pilots.
(13) High blood pressure medication. Most anti-hypertensive drugs are compatible with flying duties However, if the level of blood pressure is such that drug therapy is required, the pilot or cabin crew member should be monitored for any side effects before carrying out flying duties. Therefore, consultation with the AME, AeMC, GMP, OHMP or medical assessor as applicable, is needed.
(14) Asthma medication. Asthma has to be clinically stable before a pilot or cabin crew member can return to flying duties. The use of respiratory aerosols or powders, such as corticosteroids, beta-2-agonists or chromoglycic acid may be compatible with flying duties. However, the use of oral steroids or theophylline derivatives is incompatible with flying duty. Pilots or cabin crew members using medication for asthma should consult the AME, AeMC, GMP, OHMP or medical assessor, as applicable.
(15) Tranquillisers and sedatives. The inability to react, due to the use of this group of medicines, has been a contributory cause to fatal aircraft accidents. In addition, the underlying condition for which these medications have been prescribed will almost certainly mean that the mental state of a pilot or cabin crew member is not compatible with flying duties.
(16) Sleeping tablets. Sleeping tablets dull the senses, may cause confusion and slow reaction times. The duration of effect may vary from individual to individual and may be unduly prolonged. Expert aero-medical advice should be obtained before using sleeping tablets.
(17) Melatonin. Melatonin is a hormone that is involved with the regulation of the circadian rhythm. In some countries it is a prescription medicine, whereas in most other countries it is regarded as a ‘dietary supplement’ and can be bought without any prescription. The results from the efficiency of melatonin in treatment of jet lag or sleep disorders have been contradictory. Expert aero-medical advice should be obtained.
(18) Coffee and other caffeinated drinks may be acceptable, but excessive coffee drinking may have harmful effects, including disturbance of the heart’s rhythm. Other stimulants including caffeine pills, amphetamines, etc. (often known as ‘pep’ pills) used to maintain wakefulness or suppress appetite can be habit forming. Susceptibility to different stimulants varies from one individual to another, and all may cause dangerous overconfidence. Overdosage causes headaches, dizziness and mental disturbance. These other stimulants should not be used.
(19) Anaesthetics. Following local, general, dental and other anaesthetics, a period of time should elapse before returning to flying. The period will vary considerably from individual to individual, but a pilot or cabin crew member should not fly for at least 12 hours after a local anaesthetic, and for at least 48 hours after a general, spinal or epidural anaesthetic (see MED.A.020).
(e) Many preparations on the market nowadays contain a combination of medicines. It is, therefore, essential that if there is any new medication or dosage, however slight, the effect should be observed by the pilot or the cabin crew member on the ground prior to flying. It should be noted that medication which would not normally affect pilot or cabin crew performance may do so in individuals who are ‘oversensitive’ to a particular preparation. Individuals are, therefore, advised not to take any medicines before or during flight unless they are completely familiar with their effects on their own bodies. In cases of doubt, pilots and cabin crew members should consult an AME, AeMC, GMP, OHMP or medical assessor, as applicable.
(f) Other treatments
Alternative or complementary medicine, such as acupuncture, homeopathy, hypnotherapy and several other disciplines, is developing and gaining greater credibility. Such treatments are more acceptable in some States than others. There is a need to ensure that ‘other treatments’, as well as the underlying condition, are declared and considered by the AME, AeMC, GMP, OHMP or medical assessor, as applicable, for assessing fitness.
MED.A.025 Obligations of the AeMC, AME, GMP and OHMP
Regulation (EU) 2019/27
(a) When conducting aero-medical examinations and aero-medical assessments as required in this Annex (Part-MED), the AeMC, AME, GMP and OHMP shall:
(1) ensure that communication with the applicant can be established without language barriers;
(2) make the applicant aware of the consequences of providing incomplete, inaccurate or false statements on their medical history;
(3) notify the licensing authority, or, in the case of cabin crew attestation holders, notify the competent authority, if the applicant provides incomplete, inaccurate or false statements on their medical history;
(4) notify the licensing authority if an applicant withdraws the application for a medical certificate at any stage of the process.
(b) After completion of the aero-medical examinations and assessments, the AeMC, AME, GMP and OHMP shall:
(1) inform the applicant whether he or she is fit, unfit or referred to the medical assessor of the licensing authority, AeMC or AME, as applicable;
(2) inform the applicant of any limitation that may restrict flight training or the privileges of his or her licence or cabin crew attestation, as applicable;
(3) if the applicant has been assessed as unfit, inform him or her of his or her right to have the decision reviewed in accordance with the procedures of the competent authority;
(4) in the case of applicants for a medical certificate, submit without delay to the medical assessor of the licensing authority a signed, or electronically authenticated, report containing the detailed results of the aero-medical examinations and assessments as required for the class of medical certificate and a copy of the application form, the examination form, and the medical certificate;
(5) inform the applicant of his or her responsibilities in the case of decrease in medical fitness, as specified in point MED.A.020.
(c) Where consultation with the medical assessor of the licensing authority is required in accordance with this Annex (Part-MED), the AeMC and AME shall follow the procedure established by the competent authority.
(d) AeMCs, AMEs, GMPs and OHMPs shall maintain records with details of aero-medical examinations and assessments performed in accordance with this Annex (Part-MED) and their results for a minimum of 10 years, or for a longer period if so determined by national legislation.
(e) AeMCs, AMEs, GMPs and OHMPs shall submit to the medical assessor of the competent authority, upon request, all aero-medical records and reports, and any other relevant information, when required for:
(1) medical certification;
(2) oversight functions.
(f) AeMCs and AMEs shall enter or update the data included in the European Aero-Medical Repository in accordance with point (c) of point ARA.MED.160.
AMC1 MED.A.025 Obligations of the AeMC, AME, GMP and OHMP
ED Decision 2019/002/R
(a) If the medical examination is carried out by two or more AMEs or GMPs, only one of them should be responsible for coordinating the results of the examination, evaluating the findings with regard to medical fitness, and signing the report.
(b) The applicant should be made aware that the associated medical certificate or cabin crew report may be suspended or revoked if the applicant provides incomplete, inaccurate or false statements on their medical history to the AeMC, AME, GMP or OHMP.
(c) In cases where the AeMC or AME is required to assess the fitness of an applicant for a class 2 medical certificate in consultation with the medical assessor of the licensing authority, they should document the consultation in accordance with the procedure established by the competent authority.
(d) The AeMC, AME, GMP or OHMP should give advice to the applicant on treatment and preventive measures if, during the course of the examination, medical conditions or risk factors are identified which may endanger the medical fitness of the applicant in the future.
(e) When data is not being properly recorded in the European aero-medical data repository (EAMR due to unserviceability of the system, the AeMCs and AMEs should enter, or correct the existing data, in the EAMR without undue delay when the system recovers.
(f) In case of denial or referral to the licensing authority, the AeMC, AME, GMP or OHMP should inform the applicant in writing regarding the result of the assessment in a form and manner established by the competent authority.
GM1 MED.A.025 Obligations of the AeMC, AME, GMP and OHMP
ED Decision 2019/002/R
(a) Before performing the medical examination, the AeMC, AME or GMP should:
(1) verify the applicant’s identity by checking their identity card, passport, driving licence or other official document containing a photograph of the applicant;
(2) obtain details of the applicant’s flight crew licence from the applicant’s licensing authority if they do not have their licence with them;
(3) except for initial applicants, obtain details of the applicant’s most recent medical certificate from the medical assessor of the applicant’s licensing authority if they do not have their certificate with them;
(4) in the case of a specific medical examination(s) (SIC) limitation on the existing medical certificate, obtain details of the specific medical condition and any associated instructions from the medical assessor of the applicant’s licensing authority. This could include, for example, a requirement to undergo a specific examination or test;
(5) except for initial applicants, ascertain, from the previous medical certificate, which routine medical test(s) should be conducted, for example electrocardiography (ECG);
(6) provide the applicant with the application form for a medical certificate and the instructions for completion and ask the applicant to complete the form but not to sign it yet;
(7) go through the form with the applicant and give information to help the applicant understand the significance of the entries and ask any questions which might help the applicant to recall important historical medical data;
(8) verify that the form is complete and legible, ask the applicant to sign and date the form and then sign it as well. If the applicant declines to complete the application form fully, inform the applicant that it may not be possible to issue a medical certificate regardless of the outcome of the clinical examination and assessment.
(b) Once all the items in (a) have been addressed, the AeMC, AME or GMP should:
(1) perform the medical examination of the applicant in accordance with the applicable rules;
(2) arrange for additional specialist medical examinations, such as otorhinolaryngology (ENT) or ophthalmology, to be conducted as applicable and obtain the associated report forms or reports;
(3) complete the medical examination report form in accordance with the associated instructions for completion;
(4) ensure that all of the report forms are complete, accurate and legible.
(c) Once all the actions in (b) have been carried out, the AeMC, AME or GMP should review the report forms and:
(1) if satisfied that the applicant meets the applicable medical requirements as set out in Part-MED, issue a medical certificate for the appropriate class, with limitations if necessary. The applicant should sign the certificate once signed by the AeMC, AME or GMP; or
(2) if the applicant does not meet the applicable medical requirements, or if the fitness of the applicant for the class of medical certificate applied for is in doubt:
(i) refer the decision on medical fitness to, or consult the decision on medical fitness with, the medical assessor of the licensing authority or AME in compliance with MED.B.001; or
(ii) deny issuance of a medical certificate, explain the reason(s) for denial to the applicant and inform them of their right of a review according to the procedures of the competent authority.
(d) The AeMC, AME or GMP should send the documents as required by MED.A.025(b) to the medical assessor of the applicant’s licensing authority within 5 days from the date of the medical examination. If a medical certificate has been denied or the decision has been referred, the documents should be sent to the medical assessor of the licensing authority on the same day that the denial or referral decision is reached.