21L.B.145 Oversight activities

(a)When the competent authority verifies the compliance of the declared production organisation in accordance with point 21L.B.143 and the oversight programme established in accordance with point 21L.B.144, it shall:

1.provide the personnel responsible for oversight with guidance to perform their functions;

2.conduct assessments, audits, inspections, and, if needed, unannounced inspections;

3.collect the evidence needed in case further action is required, including the measures provided for in points 21L.B.21 and 21L.B.22;

4.inform the declared production organisation about the results of the oversight activities.

(b)If the facilities of the declared production organisation are located in more than one State, the competent authority identified in point 21L.2 may agree to have oversight tasks performed by the competent authority(ies) of the Member State(s) where other facilities are located, or by the Agency for facilities that are located in a non-Member State. Any declared production organisation that is subject to such an agreement shall be informed of its existence and of its scope.

(c)For any oversight activities that are performed by the competent authority at facilities located in a Member State other than where the organisation has its principal place of business, the competent authority shall inform the competent authority of that Member State before performing any on-site audit or inspection of the facilities.

(d)The competent authority shall collect and process any information deemed necessary for conducting oversight activities.

(e)If the competent authority detects a non-compliance of the declared production organisation with the applicable requirements of Section A and the implementation of safety measures mandated according to points (c) and (d) of point 21L.B.15, the competent authority shall act in accordance with points 21L.B.21 and 21L.B.22.