Out of focus: EC proposals for changes in the European pharmaceutical legislation that went unnoticed – Part II

In the previous article, we reviewed in detail some of the proposals of the European Commission for a comprehensive overhaul of European pharmaceutical legislation, contained in the new draft Directive on the Union code relating to medicinal products for human use (the “Directive”) and in the draft Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency (the “Regulation”), which were not addressed by the Bulgarian media.

Out of focus: EC proposals for changes in the European pharmaceutical legislation that went unnoticed – Part I

On 26 April 2023, the European Commission presented its long-awaited proposal for a comprehensive reform of the European pharmaceutical legislation. The reform aims to replace Directive 2001/83/EC on the Community code relating to medicinal products for human use with a new Directive (“the Directive”) and the integration into a new general regulation (“the Regulation”) of the Regulations establishing the European Medicines Agency and the centralised procedure for the authorisation of medicinal products (Regulation No 726/2004), orphan medicinal products (Regulation No 141/2000), advanced therapy medicinal products (Regulation No 1394/2007) and medicinal products for paediatric use (Regulation No 1901/2006).