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Feed/RSP2022/2940(RSP)Health & Social

Repeal of Regulation (EC) No 726/2004 on draft granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Spikevax - elasomeran", a medicinal product for human use

COMCMT1R-EP1R-C2R-EPCNCADO
Updated 3mo ago
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This procedure concerns an objection to a draft decision by the European Commission. The Commission proposed to grant marketing authorisation for the human medicinal product 'Spikevax - elasomeran'.

This objection, raised by MEPs, could prevent the Commission from granting the authorisation. It affects the approval process for new medicines within the EU.