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AMC1 ARO.GEN.220(a)(7) Record-keeping

ED Decision 2014/025/R

ACTIVITIES PERFORMED IN THE TERRITORY OF A MEMBER STATE BY PERSONS OR ORGANISATIONS ESTABLISHED OR RESIDING IN ANOTHER MEMBER STATE

(a) Records related to the oversight of activities performed in the territory of a Member State by persons or organisations established or residing in another Member State should include, as a minimum:

(1) oversight records, including all audit and inspection records and related correspondence;

(2) copies of all relevant correspondence to exchange information with other competent authorities relating to the oversight of such persons/organisations;

(3) details of any enforcement measures and penalties; and

(4) any report from other competent authorities relating to the oversight of these persons/organisations, including any notification of evidence showing non-compliance with the applicable requirements.

(b) Records should be kept by the competent authority having performed the audit or inspection and should be made available to other competent authorities at least in the following cases:

(1) serious incidents or accidents;

(2) findings through the oversight programme where organisations certified or authorised by another competent authority are involved, to determine the root cause;

(3) an organisation being certified, authorised or having approvals in several Member States.

(c) When records are requested by another competent authority, the reason for the request should be clearly stated.

(d) The records can be made available by sending a copy or by allowing access to them for consultation.