Medicinal products for human use and investigational medicinal products for human use

Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (COM(2023)193 final); (182 page(s), in English), (37 page(s), in English)

This Regulation lays down Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human use at Union level, establishes rules and procedures at Union and at Member State level relating to the security of supply of medicinal products and lays down the governance provisions of the European Medicines Agency established by Regulation (EC) No 726/2004 which shall carry out the tasks relating to medicinal products for human use that are laid down in this Regulation, Regulation (EU) No 2019/6 and other relevant Union legal acts.

It revises and replaces Regulation (EC) 726/2004 (general), Regulation (EC) 141/2000 (rare disease medicines) and Regulation (EC) 1901/2006 (paediatric medicines).

The Regulation contains both technical regulations and conformity assessment procedures.

1. Technical regulations: The Regulation establishes certain conditions for the marketing authorisation of medicinal products for human use at central (EU) level. The Regulation also establishes rules at Union and at Member State level relating to the security of supply of medicinal products including the monitoring and management of shortages and critical shortages.

2. Conformity assessment procedures: The Regulation establishes the procedures for the authorisation of medicinal products for human use at central (EU) level. It also establishes procedures at Union and at Member State level relating to the security of supply of medicinal products including the monitoring and management of shortages and critical shortages.