ARA.MED.330
Special medical circumstances
Regulation (EU) 2015/445
(a) When new medical technology, medication or procedures are identified that may justify a fit assessment of applicants otherwise not in compliance with the requirements, research may be carried out to gather evidence on the safe exercise of the privileges of the licence.
(b) In order to undertake research, a competent authority, in cooperation with at least one other competent authority, may develop and evaluate a medical assessment protocol based on which these competent authorities may issue a defined number of pilot medical certificates with appropriate limitations.
(c) AeMCs and AMEs may only issue medical certificates on the basis of a research protocol if instructed to do so by the competent authority.
(d) The protocol shall be agreed between the competent authorities concerned and shall include as a minimum:
(1) a risk assessment;
(2) a literature review and evaluation to provide evidence that issuing a medical certificate based on the research protocol would not jeopardise the safe exercise of the privileges of the licence;
(3) detailed selection criteria for pilots to be admitted to the protocol;
(4) the limitations that will be endorsed on the medical certificate;
(5) the monitoring procedures to be implemented by the competent authorities concerned;
(6) the determination of end points for terminating the protocol.
(e) The protocol shall be compliant with relevant ethical principles.
(f) The exercise of licence privileges by licence holders with a medical certificate issued on the basis of the protocol shall be restricted to flights in aircraft registered in the Member States involved in the research protocol. This restriction shall be indicated on the medical certificate.
(g) The participating competent authorities shall:
(1) provide the Agency with:
(i) the research protocol before implementation;
(ii) the details and qualifications of the nominated focal point of each participating competent authority;
(iii) documented reports of regular evaluations of its effectiveness;
(2) provide the AeMCs and AMEs within their jurisdiction with details of the protocol before implementation for their information.