Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance) (c. 536)

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ANNEX IIIU.K.SAFETY REPORTING

3.ANNUAL SAFETY REPORTING BY THE SPONSORU.K.

23.The report shall contain, in an appendix, the RSI in effect at the start of the reporting period.U.K.

24.The RSI in effect at the start of the reporting period shall serve as RSI during the reporting period.U.K.

25.If there are significant changes to the RSI during the reporting period they shall be listed in the annual safety report. Moreover, in this case the revised RSI shall be submitted as an appendix to the report, in addition to the RSI in effect at the start of the reporting period. Despite the change to the RSI, the RSI in effect at the start of the reporting period serves as RSI during the reporting period.U.K.