Commission Implementing Regulation (EU) 2019/27Show full title

ANNEX II

The following point is added in Section I of Subpart MED of Annex VI to Regulation (EU) No 1178/2011:

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

(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 45/2001(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.’

(1)

Regulation (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).