The objective of this Notice of Proposed Amendment (NPA) is to improve the level of safety, clarify already existing rule text in order to make the regulatory framework more precise and effective, fill the gaps identified through the implementation experience and remove unnecessary burden for competent authorities (CAs), aeromedical examiners (AMEs) and aeromedical centres (AeMCs).
In summary, the proposed amendments are expected to improve the level of safety and clarity by:
- introducing new requirements to strengthen the procedure of limitation, suspension and revocation of medical certificates in order to reflect the amendments in Annex IV (Part-MED) of Regulation (EU) No 1178/2011 (‘Aircrew Regulation’);
- introducing new requirements to reduce the burden for flight crew licence holders as well as for CAs in case of an application for the change of state of licence issue;
- introducing new requirements for cooperative oversight in cases where the activity of an AME or AeMC involves more than one Member State (MS);
- adding ‘class 3’ to the existing requirements and related training for AeMCs to ensure harmonisation between the Aircrew Regulation and Part ATCO.MED (Annex IV to Regulation (EU) 2015/340);
- adding the obligation for AeMCs to report the statistical information regarding the aeromedical assessments, including reports of the drugs and alcohol screening and risk factors identified;
- adding the possibility for AeMCs to have contracted activities;
- improving the requirement for CAs to establish a secondary review procedure in order to increase the quality of the aeromedical examinations;
- mandating the acknowledgement of AeMC’s management system assessment performed by other national authorities or organisations involved in the assessment of medical facilities.
Moreover, the proposed amendments aim to ensure harmonisation between the requirements of Part-MED, Annex VI (Part-ARA) and Annex VII (Part-ORA) to the Aircrew Regulation. Finally, the proposed amendments are expected to enhance clarity and consistency of rules in line with better regulation principles, promote a competitive environment and maintain the current level of safety through harmonisation of the Aircrew Regulation requirements.
This proposed amendment addresses efficiency/proportionality as well safety issues related to Part-ARA and Part-ORA.