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annul the EMA’s decision of 21 September 2021 (EMA/468888/2021) rejecting the applicant’s appeal of 13 August 2021 against the EMA’s decision of 28 July 2021 (EMA/421922/2021);

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grant access to the ‘c4591001-interim-ado-report-body’ study on the basis of which the EMA’s Assessment Report EMA/CHMP/282047/2021 Rev. 1 of 22 July 2021 or Commission Implementing Decision C(2021) 4034 (final) of 31 May 2021 were adopted.

1.

First plea in law, alleging invalidity by reason of an error of law concerning the classification of anonymised data records of study C4591001 in respect of US participants in the study as personal data under Regulation 2018/7125. (1)

2.

Second plea in law, alleging invalidity by reason of an error of law by the EMA in finding that study C4591001 has not been finalised as regards a change in the paediatric indication and is consistent with ‘EMA Policy(0070) on Clinical Data Publication’ (EMA/144064/2019).

3.

Third plea in law, alleging invalidity by reason of an error of law in the finding that the first indent of Article 4(2) of Regulation No 1049/2001 (2) (‘protection of commercial interests of a natural or legal person, including intellectual property’) is applicable.

4.

Fourth plea in law, alleging invalidity by reason of an error of law in the finding that there is no overriding public interest pursuant to the last sentence of Article 4(2) of Regulation No 1049/2001.