10/6/2022 1:30:24 PM | less than a minute read

Advocate General issues opinion in Tecfidera ECJ appeal

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Jamie Hatzel

Associate

Get in touch

Jamie Hatzel

Associate

Advocate General Medina has today issued his opinion on the joined appeals to the ECJ submitted by the European Commission, the European Medicines Agency and Biogen against the General Court's decision in Pharmaceutical Works Polpharma v EMA (T‑611/18).

The case concerned the interpretation of the "global marketing authorisation" concept, which is relevant to determining whether a marketing authorisation holder can benefit from regulatory data and market exclusivity.

We're processing the decision now, but it appears that the Advocate General recommends overturning the General Court's decision. More to follow on our life sciences hub, On The Pulse.

As requested by the Court, my analysis will focus, in the first place, on the interpretation of the concept of ‘global marketing authorisation’ and its objectives ... In the second place, I will examine whether the General Court could lawfully establish, in the light of the provisions of Directive 2001/83 and Regulation No 726/2004 and the principle of mutual recognition, that the Commission and the EMA have the competence to reassess the marketing authorisation of a fixed combination medicinal product granted by a national competent authority when faced with the decision as to whether a mono-substance medicinal product, composed of one of the substances of that fixed combination, belongs to the same global marketing authorisation.

curia.europa.eu/...