Judgment_paragraph 47 · GE Healthcare A/S v European Commission (T-783/17)

47In that system, the first paragraph of Article 116 of Directive 2001/83 confers rights on undertakings which are holders of MAs, since it ensures the retention of MAs as long as the existence of one of the conditions to vary, suspend or revoke them is not established (see, to that effect, judgment of 19 April 2012, Artegodan v Commission, C‑221/10 P, EU:C:2012:216, paragraph 96). It follows that, as regards the burden of proof, it is for the competent authority, in this case the Commission, to establish that the conditions relating to the revocation, suspension or modification of an MA, set out in Article 116 of Directive 2001/83, are met (judgment of 7 March 2013, Acino v Commission, T‑539/10, not published, EU:T:2013:110, paragraph 79).