4.2What information shall be collected by the competent authority and how should it be handled?

• GM to Reg. (EU) No 376/2014 and its IRs found in: Occurrence Reporting (376/2014) (Dec 2022)

4.2 What information shall be collected by the competent authority and how should it be handled? GM to Reg. (EU) No 376/2014 and its IRs Detailed information on the type of information to be collected by the competent authority is provided in Section [3.7](#_DxCrossRefBm2103820834). Regulation 376/2014 establishes two different systems, the mandatory one and the voluntary one, in order to clarify reporting obligations for reporters and for organisations. It is understood that this differentiation has no impact at the level of the competent authority. <table border="1" cellpadding="0" cellspacing="0"><tr><td valign="top" width="599"><p align="center">Key principle</p><p>All occurrences reported by an organisation to its competent authority in application of Regulation 376/2014 and its implementing rules shall be handled and addressed in the same manner by this competent authority.</p><p>All occurrences directly by an individual reporter to a competent authority, whether or not it is reported on the basis of Regulation 2015/1018, shall be handled and addressed in the same manner by that competent authority</p><p>In general, Regulation 376/2014 does not differentiate the way mandatorily reportable and voluntarily reportable occurrences shall be addressed by the competent authority.</p><p>It does, however, impose differentiated requirements to the competent authority for handling, from one side, occurrences transferred by an organisation and, from the other side, occurrences directly reported by an individual.</p></td></tr></table> All information collected from organisations, whether it was reported in application of [Article 4](#_DxCrossRefBm2103820737) or of [Article 5](#_DxCrossRefBm2103820741), is subject to similar handling by the competent authority. And all information directly reported by individuals to the competent authority, whether it was reported in application of [Article 4](#_DxCrossRefBm2103820737) or of [Article 5](#_DxCrossRefBm2103820741), is subject to the same analysis and follow-up obligations. More detailed information on the way information collected should be handled is included in the questions below.