The assessment of the annual safety reports
Article 7
1. When assessing annual safety reports, the safety assessing Member State shall: (a) assess the information in all annual safety reports relating to the use of the active substance in clinical trials authorised in the Union, regardless of the pharmaceutical form and strength or indication investigated and regardless of whether the active substance is used in several clinical trials managed by different sponsors; (b) request additional information pursuant to Article 5(1), point (d), from sponsors and assess their responses. If a sponsor does not provide the information within the deadline set in the request, the safety assessing Member State shall inform relevant reporting Member States and Member States concerned to consider taking corrective measures in accordance with Article 77 of Regulation (EU) No 536/2014; (c) submit the final assessment report in the information systems referred to in Article 11 within 42 days after the submission of the latest annual safety report or within a maximum of 84 days from the submission of the latest annual safety report if additional information is requested pursuant to point (b); (d) when necessary, address any safety concerns identified during the assessment, develop recommendations for corrective measures and other actions for safety oversight related to the active substance, and communicate them to the reporting Member States and to the Member States concerned. 2. The safety assessing Member State may increase the extent and shorten the timelines of the assessment referred to in paragraph 1 if the risk to safety of participants in a clinical trial so requires. In this assessment, the safety assessing Member State shall take into account the marketing authorisation status of the investigational medicinal product or active substance, the state of knowledge about the safety profile of the active substance and the degree of deviation in the use of the active substance from normal clinical practice. 3. By way of derogation from paragraph 1, when the sponsor submits a single annual safety report specific to a single clinical trial involving several investigational medicinal products pursuant to Article 43(2) of Regulation (EU) No 536/2014, this annual safety report shall be assessed by the reporting Member State of this particular clinical trial. Upon request of the reporting Member State, the safety assessing Member States for the active substances included in these investigational medicinal products shall support the reporting Member State with this assessment. The reporting Member State shall submit a final assessment report to the information systems referred to in Article 11, and, where necessary, notify safety concerns to the Member States concerned and to every responsible safety assessing Member State for the active substance(s) included in the investigational medicinal products concerned.