On July 29, 2019, the EU Court of Justice rejected the appeal filed by the EMA under Case C-359/18 P and clarified that under certain conditions, a medicinal product can obtain the orphan drug designation even though it contains the same active substance of an existing orphan drug already authorized. The Court of Justice reached this conclusion on the basis of the combined reading of Section 3, paragraph 1, and Section 5, paragraph 2 of Regulation (EC) No. 141/2000, which stipulate that for a specific therapeutic indication in which an authorized medicinal product is already available, the pharmaceutical company seeking the orphan designation must establish that its product will provide significant benefits with respect to the existing one and that the two products are not identical. The EMA claims that the “active ingredient” and the “therapeutic indication” of a medicinal product are essential elements in establishing whether a medicinal product is identical to another already authorized, and these information must be included in the application for the orphan drug designation. Conversely, the Court of Justice highlighted the fact that "medicinal product" and "active substance" are different concepts, as the latter is just a component of the former. Further, pursuant to Directive 2001/83/EC, in order to establish the identity between two medicinal products, other relevant factors must be taken into account, such as the drug’s excipients.