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

Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (COM(2023)192 final); (184 page(s), in English), (103 page(s), in English)

This Directive lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of medicinal products for human use. It repeals and replaces Directive 2001/83/EC and Directive 2009/35/EC and it incorporates relevant parts of Regulation (EC) No 1901/2006;

The Directive contains both technical regulations and conformity assessment procedures.

1. Technical regulations: The Directive establishes standards of quality, safety and efficacy for the authorisation of medicinal products as it establishes the conditions for the marketing authorisation of medicinal products for human use at central (EU) and national (in different Member States) levels. The Directive also establishes the conditions for the manufacturing authorisation and wholesale distribution authorisation. It moreover establishes requirements on labelling and packaging.

2. Conformity assessment procedures: The Directive establishes the procedures for the authorisation of medicinal products for human use at central (EU) and national (in different Member States. It also establishes procedures for the manufacturing authorisation and wholesale distribution authorisation. The Directive moreove establishes procedures for controls, supervision and inspections.