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set aside the judgment under appeal;

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reject the application for annulment in Case T-611/18; and

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order the applicant at first instance to pay the costs related to Case T-611/18 and the costs related to the present appeal proceedings.

1.

Under the first ground of appeal, EMA submits that the General Court committed a two-fold error, insofar as it failed to infer from the fact of the recent renewal of the marketing authorisation for a combination medicinal product that said renewal would have been undertaken against the evidence available at the time of the renewal and the regulatory standards applicable at the time of the renewal.

2.

Under the second ground of appeal, EMA submits that the General Court erred in law, insofar as it considered that EMA and the Commission perform a particular function that required the latter to verify the therapeutic effect of one of the active substances of a nationally authorised combination product, when ascertaining the data protection rights of a centrally authorised monotherapy containing one of the active substances of the combination product.

3.

Under the third ground of appeal, EMA submits that the General Court erred in its interpretation of Article 6(1), second subparagraph, of Directive 2001/83/EC (1), insofar as it considered that the Global Marketing Authorisation test involves the verification by the Commission of the therapeutic effect of one of the active substances of a nationally authorised combination product.

4.

Under the fourth ground of appeal, EMA submits that the General Court exceeded the scope of its power of judicial review, insofar as it embarked on a de novo assessment of certain scientific evidence, and insofar as it reproached the Commission for not investigating the supposed doubts that purportedly surrounded this scientific evidence.