Judgment_paragraph 73 · Fresenius Kabi Austria GmbH and Others v European Commission (T-416/22)

73In that regard, the applicants submit that the risk-benefit balance, as defined in Article 1(28a) of Directive 2001/83, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (OJ 2004 L 136, p. 34), is assessed primarily in the light of the intended use of the medicinal product, which is defined by the MA indications and the related restrictions on use also mentioned in the MA. According to Article 1(28) of Directive 2001/83, as amended by Directive 2004/27, the term ‘risk’ encompasses any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health. In accordance with recital 7 of Directive 2001/83, the concepts of harmfulness and therapeutic efficacy can only be examined in relation to each other and only have a relative significance assessed in the light of the state of progress of science and taking into account the intended purpose of the medicinal product. The quality, efficacy and safety of the medicinal product is always linked to its intended use, which is examined during the authorisation procedure. No medicinal product can be safe and effective if it is not used as indicated.

Fresenius Kabi Austria GmbH and Others v European Commission (T-416/22)

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