Judgment_paragraph 9 · European Commission and Others v Pharmaceutical Works Polpharma S.A (C-438/21 P)

9Under Article 3(3) of that regulation:‘A generic medicinal product of a reference medicinal product authorised by the [European Union] may be authorised by the competent authorities of the Member States in accordance with Directive 2001/83/EC and Directive 2001/82/EC [of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p. 1)] under the following conditions:(a) the application for authorisation is submitted in accordance with Article 10 of Directive 2001/83/EC or Article 13 of Directive 2001/82/EC;(b) the summary of the product characteristics is in all relevant respects consistent with that of the medicinal product authorised by the [European Union] except for those parts of the summary of product characteristics referring to indications or dosage forms which were still covered by patent law at the time when the generic medicine was marketed; and(c) the generic medicinal product is authorised under the same name in all the Member States where the application has been made. For the purposes of this provision, all the linguistic versions of the INN (international non-proprietary name) shall be considered to be the same name.’