62021CJ0438_SUM
Joined Cases C‑438/21 P to C‑440/21 P
European Commission and Others
v
Pharmaceutical Works Polpharma S.A.
Judgment of the Court (Fourth Chamber) of 16 March 2023
(Appeal – Public health – Medicinal products for human use – Directive 2001/83/EC – Regulation (EC) No 726/2004 – Application for marketing authorisation for a generic version of the medicinal product Tecfidera – Decision of the European Medicines Agency (EMA) not to validate the application for marketing authorisation – Earlier European Commission decision taking the view that Tecfidera was not covered by the same global marketing authorisation as Fumaderm – Previously authorised combination medicinal product – Subsequent marketing authorisation for a component of the combination medicinal product – Assessment of the existence of a global marketing authorisation)
Approximation of laws – Medicinal products for human use – Marketing authorisation – National authorisation for a combination medicinal product and subsequent authorisation at EU level for a component of that combination – Commission decision finding that there are two different global marketing authorisations
(Commission Regulations No 1085/2003 and No 1234/2008, Art. 2 and Annex I; European Parliament and Council Directive 2001/83, recital 9, Arts 1(3)a, 6(1) and 10(1))
(see paragraphs 82-94)
Appeal – Appeal upheld – Judgment to be given on the substance by the appeal court – Condition – Whether the state of the proceedings permits final judgment to be given
(Statute of the Court of Justice, Art. 61, first para.)
(see paragraphs 97, 98)
See the text of the decision.