Judgment_paragraph 101 · GE Healthcare A/S v European Commission (T-783/17)

101In any event, the Commission rightly points out that when questions which are relevant to the EU are brought before a committee, such as the PRAC or the CHMP, in the context of the procedure set out in Article 31(1) of Directive 2001/83, it is for that committee to carry out, at European level, its own assessment of the relevant medicinal product, which is independent of the assessment by the national authorities, and this assessment cannot be used to challenge the committee’s assessment (see, to that effect, judgment of 3 December 2015, PP Nature-Balance Lizenz v Commission, C‑82/15 P, not published, EU:C:2015:796, paragraphs 36 and 37).