EU: New pharmaceutical legislation published

 

EU published a proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products.

The Regulation would also establishe 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.

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.

The Regulation would amend 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.

The proposed date of adoption is 31 December 2024.

The full text of the Regulation is available HERE.

To find out more about regulations for pharmaceuticals, please contact the Product Compliance Institute directly.