27In that regard, it should be observed, first, that the purpose of the requirement for applicants seeking marketing authorisation to attach to their application the results of preclinical tests and clinical trials, laid down in Article 8(3)(i) of Directive 2001/83, is to provide proof of the safety and efficacy of the medicinal product concerned (see, to that effect, judgment in Generics (UK), C‑527/07, EU:C:2009:379, paragraph 22 and the case-law cited).
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.