53As regards judicial review of the CHMP opinion — and by extension of its assessment report — the Court cannot substitute its own assessment for that of the CHMP. Only the proper functioning of the CHMP, the internal consistency of the opinion and the statement of reasons contained in it can be subject to judicial review. As regards the last aspect, the review consists of examining whether these documents contain a statement of reasons from which it is possible to ascertain the considerations on which they are based and whether they establish a comprehensible link between the medical or scientific findings and the conclusions (see, to that effect, judgments of 7 March 2013, Acino v Commission, T‑539/10, not published, EU:T:2013:110, paragraph 93, and of 5 December 2018, Bristol-Myers Squibb Pharma v Commission and EMA, T‑329/16, not published, EU:T:2018:878, paragraph 99; see also, to that effect and by analogy, judgment of 26 November 2002, Artegodan v Commission, T‑74/00, T‑76/00, T‑83/00 to T‑85/00, T‑132/00, T‑137/00 and T‑141/00, EU:T:2002:283, paragraph 200).
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.