# Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (Text with EEA relevance), Division ARA.MED.330: Special medical circumstances

Extent: E+W+S+N.I.

(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, the CAA may develop and evaluate a medical assessment protocol based on which the CAA 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 CAA.
(d)The protocol 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 ...;
(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 by the CAA on the basis of the protocol shall be restricted to flights in aircraft registered in the United Kingdom. This restriction shall be indicated on the medical certificate.
(g)The CAA must provide the AeMCs and AMEs with details of the protocol before implementation for their information.

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Source: https://www.legislation.gov.uk/eur/2011/1178/annex/VI/division/SUBPART+MED/section/III/division/ARA.MED.330 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-1178/annex-VI/division-SUBPART+MED/section-III/division-ARA.MED.330
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.