Changing the Safety Assessing Member State
Article 4
1. When the safety assessing Member State of an active substance is no longer a Member State concerned in any clinical trial involving the use of that active substance, or where a safety assessing Member State has a disproportionate workload in comparison to other Member States, that safety assessing Member State may initiate the procedure for the selection of a new safety assessing Member State in accordance with Article 3(2). That procedure shall, if possible, be launched after the submission by the safety assessing Member State of the final assessment report of the annual safety report. The safety assessing Member State initiating the procedure referred to in the first subparagraph shall fulfil the tasks assigned to the reporting Member State in Article 3(2). 2. Any Member State can volunteer at any time to take over the role of the safety assessing Member State, provided that the original safety assessing Member State agrees. 3. When a new safety assessing Member State is appointed pursuant to paragraph 1 or 2, the original safety assessing Member State shall record its identity in the information systems referred to in Article 11 for each relevant clinical trial without undue delay. 4. In the situations referred to in paragraphs 1 and 2, the original safety assessing Member State shall continue carrying out its tasks until all final safety assessment reports and records, including the assessment report of the last annual safety report, have been submitted and the new safety assessing Member State has been recorded in the information systems referred to in Article 11 in accordance with paragraph 3. 5. By way of derogation to paragraph 4, the original safety assessing Member State shall be able to resign immediately without finalising the ongoing assessments and without submitting the corresponding assessment reports and records, provided that the new safety assessing Member State agrees.