Chapter II, Article 3, Paragraph 2. · Commission Implementing Regulation (EU) 2022/20

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2.In the situations described in paragraph 1, points (a) and (b), any Member State, whether or not it received the application referred to in those points, may express interest, through the IT tools as described in Article 11, to become the safety assessing Member State, within 7 days after the authorisation of the clinical trial or of the substantial modification in the second Member State concerned. If more than one Member State expresses interest, the reporting Member State selects the safety assessing Member State within 5 days from the end of the 7 days period referred to in the first sentence, taking into account the existing expertise of the Member States relating to the active substance and the fair division of workload between Member States. If no Member State expresses interest, the reporting Member State, within 12 days after the authorisation of the clinical trial or of the substantial modification in the second Member State concerned, shall appoint the safety assessing Member State from among the Member States concerned, taking into account the fair division of workload between them.