Parliament adopts rules on medicines authorisation and EMA governance
Decision
The European Parliament approved the Commission proposal COM(2023)0193 and the Parliament’s amendments as set out in report A9-0141/2024 from the Committee on the Environment, Public Health and Food Safety with rapporteur Tiemo Wölken; the text [P9_TA(2024)0221] was adopted by a majority of the votes cast in plenary (PV 10/04/2024 - 21.46) and Parliament’s first reading closed.
What Changes
The adopted regulation lays down Union procedures for the authorisation and supervision of medicinal products for human use and establishes rules governing the European Medicines Agency. It amends Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repeals Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006.
Who Is Affected
The measures concern the authorisation and supervision of medicinal products for human use and the rules governing the European Medicines Agency.
Sources
Official Documents
- Wednesday, 10 April 2024 - Brussels Parliament adopted the regulation on Union procedures for medicinal product authorisation and supervision and EMA governance; first reading closed.
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